PHARMADOCX (Pharma Consultant)

Transcription

1 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 1 NEW DRUG LIST MAY 2017 PHARMADOCX (Pharma Consultant) Consultant for Setting up: Pharmaceuticals, Cosmetics, Medicals Devices, Bandages and Diagnostic Kit Factory & Grant of ISO, WHO GMP Office. : Opp. Dewan Mill,Old D.C. Road, Sonepat Ph , (M) , whogmp@pharmadocx.com, Web : Blog: Skype : Yashdeep Pharmaceuticals

2 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 2 COMPANY PROFILE Founded in 2007, Pharmadocx is an India based FDA consultation firm providing consultation services to Pharmaceutical & allied industries. OUR ACTIVITIES:- Designing of plant, supervision of construction of plant & FDA approval. Upgradation of existing plant as per WHOGMP. WHO GMP certification of plant. Preparation of Registration Dossiers. Pharmadocx provides services for following types of plants. Pharmaceutical Formulation, API, Homoeopathic & Herbal formulation plants, Medical Devices Plant, Surgical Dressing Plant, Medical Oxygen Plant, Diagnostic Kits & Cosmetics Plant. PHARMACEUTICAL STATIONARY We are pleased to offer Pharmaceutical, Cosmetics & Medical Devices Stationary. Various types of registers are needed for maintaining records as per Schedule M, M-I, M-II, M-III U, U1. We can provide following pre printed registers, duly bound, page numbered, as per Drugs & Cosmetics Rules:- 1. Production Register 2. Raw Material Stock Register ( As per Schedule U for Drugs) 3. Raw Material Stock Register ( As per Schedule U1 for Cosmetics) 4. Raw Material Sampling Register 5. RLAF Log Book Register 6. Packing Material Stock Register 7. Finished Goods Stock Register 8. Chemical Stock Register 9. Control/ Retain Sample Register 10.Potable/ Purified Water Tank Cleaning Record Register 11. Temperature / Humidity Record Register 12. RM/ PM/FG Entry Register in Lab 13.Daily ph Meter Standardisation Register 14.Equipment operation & cleaning log book Register 15.Building Maintenance Record 16.Service Record of Machine

3 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 3 Name of Drug Approval Date 1 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg & 2 23/06/2010 tablet of Nevirapine 200mg combipack 1 tablet of Atazanavir 300mg & 1 tablet of ritonavir Ritonavir 100mg & FDC 19/07/10 of Tenofovir Disoproxil fumarate 300mg + Lamivudine 300mg (Each Copack contains :- 1 capsule of Atazanavir 300mg & 1 Tablet of Ritonavir 100mg & 1 Tablet of FDC of Tenofovir Disoproxil Fumarate 300mg + Lamivudine 300mg) 1 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg & 2 tablet of 23/06/2010 Nevirapine 200mg combipack 1-(2-tetrahydrofuryl)-5-flourouracil Jun, Bromo-2-nitropropan-1,3-diol Sep, Pyrrolidone Acetamide Dec, Pyrrolidone Acetamide Capsule 400 mg Jan, Pyrrolidone Acetamide Injection 200mg/ml Jan, thymyl-oxy-methyl glyoxalidine hydrochloride Nasal Spray Jan, tablets of artesunate 100mg + 3 tablets of Artesuante 50mg & 2 28/05/2010 tablets of FDC of Pyrimethamine 25mg + Sulphadoxine 500mg combipack 3 tablets of artesunate 100mg + 3 tablets of Artesuante 50mg & 2 tablets of 28/05/2010 FDC of Pyrimethamine 25mg + Sulphadoxine 500mg combipack 3,5-Dinitro-o-toluamide Jan, mg of elemental iron in a complex of iron polymaltose + Vit. B6-2mg + Feb-77 Vit. B12 40mcg tablet 50mg of elemental iron in a complex of iron polymaltose aq. solution + Vit. Feb-77 B6 2mg + Vit. B12 5mcg Syrup 5-Aminosalicyclic acid Jun-89 5-Fluorouracil Capsule 250 mg Nov, Fluorouracil Oral Solution 250mg/5ml Jan, Methylsulphadiazine aminopenicillanic acid Capsule, 250 & 500 mg May, aminopenicillanic acid Injection 250 & 500 mg Aug, aminopenicillanic acid Oral Suspension 125mg/5ml, 250mg/5ml Aug, pills of 0.5mg Norethindrone & 35 mcg ethinylestradiol Tablets, 7 pills Jan-88 of 0.75mg Norethindrone & 35 mcg ethinylestradiol Tablets and 7 pills of 1mg Norethindrone & 35 mcg ethinylestradiol Tablets Abacavir Abacavir Sulfate Tablet 60mg Abacavir Sulphate syrup 20mg/ml 29/08/06 Abatacept powder for injection 250mg/vial Abatacept Injection 250mg/vial (Addl. Indication) Abatacept Injection 250mg/vial (additional indication) Abciximab Abiraterone acetate Tablet 250 mg (Additional Indication) Abiraterone Acetate Tablet 250 mg (Additional Indication) Abiraterone Acetate Tablets 250mg Acamprosate Calcium

4 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 4 Acarbose Acarbose 25mg/50mg + Metformin 500mg/500mg FC Tablet Acarbose tabs 50mg/100mg 6-Mar-97 Acebrophylline capsules 100mg Acebrophylline SR Tablet 200 mg Acebrophylline Syrup 10mg/ ml Acebrophylline Syrup 10mg/ml (Additional Indication) Acebutolol HCl 200mg + HCTZ 12.5mg Aug-86 Acebutolol Hydrochloride injection 5 mg Dec-85 Acebutolol Hydrochloride capsule 100 mg/ 200 mg/ 400 mg Dec-85 Aceclofenac Aceclofenac gel 1.5% alongwith linseed oil, menthol, Salicylate, Capsaicin 06/08/2005 gel Aceclofenac (100 mg) + Paracetamol (500 mg) Aceclofenac 1% w/w + Menthol 5% Spray 28/05/2010 Aceclofenac 100mg + Tizanidine 2mg film coated tablets Aceclofenac 100mg + Paracetamol 500mg tablets Aceclofenac 200mg (S.R) tablet 22/02/2006 Aceclofenac 200mg / 200mg SR + Rabeprazole 10mg / 20mg Capsule Aceclofenac dispersible tablet 100mg (new dosage form) 21/12/06 Aceclofenac gel 1.5% alongwith Linseed Oil, Menthol, Salicylate, Capsaicin 8/6/2005 Aceclofenac Inj. (150mg/ml) 28/09/06 Aceclofenac Inj. 50mg/ml (additional strength) 12/1/2006 Aceclofenac injection (150mg/3ml) Aceclofenac injection 150mg/ml Aceclofenac IP (Sustained released pellets) 200mg/200mg Thiocolchicoside IP (Sustained released pellets) 8mg/16mg Capsules. (New Dosage Form) Aceclofenac Roll - On 1% Aceclofenac 100mg + Tizanidine 2mg film coated tablets Aceclofenac (100mg) + Thiocolchicoside (4 mg) tablets (Additional strength) Aceclofenac (100mg) + Thiocolchicoside (8 mg) tablets Acesulfame Potassium Acetyl Cysteine Eye Drops 5% w/v Acetyl salicylic acid 100mg + Cal. Carbonate 30mg + Anhydrous citric acid Sep-91 10mg Tablet Acetylsalicyclic acid 350mg + Al. Hydroxide 90mg + Mg. Hydroxide tablet Nov-81 Acipimox Capsules 250mg Acitretin 9/9/2005 Aclarubicin HCl Mar-88 Aclarubicin Inj. Mar-88 Acotiamide Hydrochloride Bulk & Tablet 100mg Acrivastine Capsules 8mg Actarit 100mg Tablets Activated Dimethicone 50mg + Magnesium Hydroxide 250mg+ Dried 28/05/2010 Aluminium Hydroxide250 mg + Sorbitol (70%)1.25 gm /5ml Solution

5 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 5 Activated Methylpolysiloxane 125mg + Magnesium Hydroxide 100mg + Jun-73 Aluminium Hydroxide 5gm per 5ml solution Acyclovir 1985 to 87 Acyclovir 50g + Hydrocortisone 10mg Cream Acyclovir SR Tablet 1200 mg Acyclovir Tablets/ Cream/ Ointment/ Ophthalmic Ointment May-87 Adapalene 0.1% + Benzoyl Peroxide 2.5% gel Adapalene1mg +Clindamycin Phosphate eq. to Clindamycin 10mg per gram Gel Adefovir Dipivoxil 4/3/2004 Ademetionine enteric coated Tablets 200mg/400mg Adenosine Adenosine injection 6 mg /2ml 8-Jul-97 Adenosylcobalamin 15mcg + Ferrous Ascorbate 100mg + Folic Acid IP mg + Zinc Sulphate USP Eq. to Elemental Zinc 22.5mg tablet Afatinib Tablets 20mg/30mg/40mg/50mg (Free base) corresponding to Afatinib dimaleate 29.56mg/44.34mg/59.12mg/73.9mg (Additional Indication) Agomelatine Tablets 25mg Akiskiren Hemifumarate eq. to Aliskiren mg/150mg/300mg/300mg +Amlodipine Besilate IP eq. to Amlodipine 5mg/10mg/5mg/10mg Tablets Albendazole 3\1979 to 7/1981 Albendazole 400 mg + Ivermectin 6 mg tablet Albendazole Suspension 2.5 % w/v & 10% w/v Oct, 1979 Albendazole suspension 200mg / 5 ml Feb-86 Albendazole tablet 200mg / 400 mg Feb-86 Albendazole tablet 400mg and suspension 400mg/10ml (Additional 28/11/2011 Indication) Albendazole 400 mg + Ivermectin 6 mg tablet Alcaftadine Eye Drops 0.25% w/v & Bulk Alclometasone Dipropionate 1985 to 87 Alclometasone Dipropionate cream/ointment 0.05% Jul-87 Alendronate 70mg + Colealciferol 140mcg (5600 IU) Tablets Alendronate Sodium 18-Sep-97 Alendronate Sodium (equiv. to Alendronic acid 70mg) + Cholecalciferol 02/01/ mcg (equiv. to 2800 I.U Vit.D) Tablet Alendronate Sodium tab -10mg 18-Sep-97 Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg tablet Aliskiren 150/150/300/300mg + HCTZ 12.5/25/12.5/25mg tablets Aliskiren 150/160mg + Valsartan 300/320mg tablets 19/01/2010 Aliskiren Tablet 150mg/300mg Alkyl dimethyl benzoyl ammonium chloride 5% + Nonyl phenolethoxide 6% Inert ingredient 89% Allergen extracts Jan,1979 Almotriptan Tablet 6.25mg/12.5mg Alogliptin Tablet 6.25 mg/12.5 mg/ 25 mg

6 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 6 Alpha chymotrypsin 60mg + Ethyl nicotinate 200mg per 20gm ointment Sep-71 Alpha chloropyridazine sodium10gm + trimethoprim 2gm per 00gm powder May-90 for vetarnary use Alpha Lipoic acid 100mg + Folic acid 1.5mg + Methylcobalamin 1500mcg Pyridoxine Hydrochloride 3mg + Vitamin D IU Tablets Alpha Lipoic Acid USP 100mg + Methylcobalamin 1500mcg + Vitamin B IP 3mg + Folic Acid IP 1.5mg + Benfotiamine 50mg + Biotin USP 5mg + Chromium Picolinate USP Eq. to Chromuim 200mcg Capsule Alphachymotrypsin injection 5mg/vial Aug,1973 Alphachymotrypsin Tablet 25 chg units Jul,1975 Alprazolam Dispersible Tab mg/0.25mg/0.50mg 20/09/06 Alprazolam SR 0.25mg + Sertraline (As Hcl) 25mg/50mg tablet 9/8/2006 Alprazolam SR 0.25mg + Sertraline (As Hcl) 25mg/50mg tablet 08/09/2006 Alprazolam SR tab 1.5mg Alprazolam sublingual tablets 0.5mg/1mg (New dosage form) 27/10/2011 Alprazolam tablets 0.25 mg/0.5 mg/ 1 mg Jun-88 Alprostadil Injection Altretamine Altretamine caps -50mg 29-Mar-05 Aluminium hydroxide paste eq. to Dried Aluminium hydroxide gel IP 250mg Magnesium hydroxide paste eq. to Magnesium hydroxide IP 250mg + Simethicone Emulsion USP eq. to Simethicone 50mg + Oxetacaine BP 10mg Each 5 ml Contains: Aluminium sodium silicate + Magnesium hydroxide + Methypolysiloxane Jun-67 Tablet Amantadine Hydrochloride Dec,1972 Ambodryl 100mg + Aspirin 190mg + Phenacetin 65mg + Caffiene 15mg + Nov-70 Phenylephrine HCl 10mg + Aluminium hydroxide gel 100mg tablet Ambrisentan film coated Tablets 5 mg / 10mg 24/05/2010 Ambroxol (as Hcl) S.R. 7.5mg+ Doxycyline Hcl 100mg tablet Ambroxol + loratadine + Guaifenesin Syrup (30mg + 5mg + 50mg per ml) Ambroxol 30mg + Gnaiphenesin 100mg + Menthol 1mg + Psendoephedrine mg per 5ml syrup Ambroxol Hcl 30mg + Guaiphenesin 200mg tablet Ambroxol HCl 75mg (S.R) + Desloratadine 5mg Capsule. 11/10/2005 Ambroxol tablet/liquid/drops [1. Each tab. Contains, Ambroxol HCL-30mg, 1-Dec Each 5ml liquid contains, Ambroxol HCL-30mg, 3. Each ml drops contains, Ambroxol HCL-7.5mg] Ambroxol + Doxycyline Ambroxol + loratadine + Guaifenesin Syrup (30mg + 5mg + 50mg per 5ml) Ambroxol 30 mg+ Terbutaline 2.5 mg + Guaiphenesin 100mg + Menthol mg per 5 ml syrup Ambroxol 30mg + Levo salbutamol 1mg+Guiphenesin 50mg /5ml syrup Ambroxol 30mg + Terbutaline 2.5mg + Guaiphenesin 100mg + Menthol mg per 5 ml syrup (additional strength)

7 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 7 Ambroxol HCl 15mg + Salbulamol 1mg + Guaiphenesin 50mg + Methol mg per 5 ml syrup Ambroxol HCl 15mg + Guaiphenesin 100mg + Ethanol 95% eq.to. Ethanol % v/v per 5 ml oral liquid Ambroxol HCl 30mg + Guaiphenesin 100mg + Terbutaline sulphate 2.5mg per 10ml Syrup Ambroxol HCl 75mg (S.R) + Desloratadine 5mg Capsule. 11/10/2005 Ambroxol HCl. 15mg + Guiphenesin 50mg + Terbutalin sulphate 1.25mg Menthol 2.5mg per 5 ml of syrup Ambroxol Hydrochloride Ambroxol 30mg + Levo salbutamol 1mg+ Guiphenesin 50mg /5ml syrup Ambroxol+Pseudoephedmine+Chlorpheniramin e maleats tabs/suspension/syrup Amifostine Sep-84 Amikacin 1985 to 87 Amikacin injection Jun-86 Amiloride 5mg / 5mg + Frusemide 20mg/40mg tablet Jun-89 Amiloride 5mg + HCTZ 50mg Tablet Sep-79 Amiloride HCl 3/1979 to 7/1981 Amiloride HCl Tablet 5 mg Sep, 1979 Amiloride+ Frusemide Jun-89 Amineptine Jan-88 Amino acid 5% w/v IV Infusion with & without electrolytes Amino Acid, Glucose Parentral Solution (Solution for intravenous infusion) Aminoglutethimide Aug-85 Aminomix-2 Infusion Solution Solution A 500ml & 7 Solution B 500ml Aminophylline CR 225/350mg Aminosidine Sulphate Inj. Vial, 500mg May, 1976 Amiodarone HCl Apr-90 Amiodarone Injection (additional Indication). 5/10/2007 Amisulpiride 300mg tablets (Additional Strength) Amisulpiride SR Tablet 100 mg Amisulpiride Tablet (50/100/200mg) 1/8/2006 Amisulpride 400mg tablet (additional strength) 1/12/2006 Amisulpride S.R.Bilayered tablet 200/400mg Amitraz Aug Amitraz 2%w/v pour on solution 12/6/2010 Amitriptyline Hydrochloride IP 4%w/w + Ketamine HCL eq. to Ketamine 2% w/w per gm cream. Amitriptyline Hydrochloride IP 4%w/w + Ketamine HCL eq. to Ketamine 2% w/w per gm cream. Amitryptylline Hydrochloride Tablet 75 mg Oct,1978 Amlexanox Oral Paste (5%) Amlodipine Amlodipine (5mg) + Nebivolol (5mg) tablet (addl. Strength) Amlodipine Besylate IP Eq. to Amlodipine 10mg/5mg/2.5mg Telmisartan 80mg/40mg/ 20mg + HCTZ 25mg/12.5mg/12.5mg tablet

8 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 8 Amlodipine (5 mg) + Ramipril (2.5 mg) tablet Amlodipine (5mg) + Nebivolol (5mg) tablet (addl. Strength). 6/9/2007 Amlodipine (as besylate ) 5mg + Losartan Pot. 50mg tablet. 12/08/2005 Amlodipine (As besylate )5mg/10mg + Perindopril 4mg tablet Amlodipine (As besylate) 10mg + Perindopril 8mg tablets (additional strength) Amlodipine (as besylate) -2.5mg/5mg + Benazepril-10mg/20mg capsule Amlodipine (as besylate) 5mg + Bisoprolol 5mg Tablet (Addl. Strength) Amlodipine (as besylate) 5mg + HCTZ 12.5mg Tablet 24/04/2006 Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER 25mg (additional strength) Amlodipine (as besylate) 5mg + Metoprolol Succinate equivalent to 5/6/2006 Metoprolol Tartrate 50mg. Amlodipine (As besylate) 5mg/10mg + Perindopril 4mg tablet Amlodipine (as besylate) 5mg/2.5mg + HCTZ12.5mg/12.5mg Tablet 24/04/2006 Amlodipine (As besylate) 5mg/5mg/10mg + valsartan 80mg/160mg/160mg tablet Amlodipine + Enalapril Amlodipine + Metoprolol (2.5/5 mg + 25/50mg (ER)) Tablets Amlodipine + Metoprolol (2.5mg/5mg + 25mg/50mg (ER) Tablets(additional strength) Amlodipine 10mg/10mg+ Telmisartan 40mg/80mg Tablets (Additional Strength) Amlodipine 2.5/5/5mg + Metoprolol 25/50/25mg Capsules Amlodipine 25mg + Metoprolol 25mg (additional lower strength) 1/11/2006 Amlodipine 25mg + Metoprolol 25mg (additional lower strength) tablet 11/01/2006 Amlodipine 5 mg + Ramipril 2.5mg capsule Amlodipine 5mg/10mg/5mg/10mg/10mg + Valsartan 160mg/160mg/160mg/ mg/320mg + Hydrochlorothizide 2.5mg/12.5mg/25mg/ 25mg/ 25mg Tablets Amlodipine 5mg/2.5mg + Enalapril Maleate 5mg/2.5mg tablets Amlodipine 5mg/2.5mg + Valsartan 320mg/80mg + HCTZ 12.5mg/12.5mg tablet (additional strength) Amlodipine besilate IP Eq. to Amlodipine 10mg + Indapamide SR 1.5 mg Tablet (Additional Strength) Amlodipine Besilate IP Eq. to Amlodipine 5mg + Indapamide USP SR 1.5mg Tablet Amlodipine Besilate IP eq. to Amlodipine 5mg + Perindopril Erbumine BP mg Tablets (Additional Strength) Amlodipine Besilate IP eq.to Amlodipine 10mg/5mg/5mg/5mg/2.5mg Olmesartan Medoxomil 40mg/40mg/20mg/5mg/5mg + Hydrochlorothiazide IP 25mg/12.5mg/12.5mg/12.5mg/12.5mg Tablet Amlodipine Besilate tablets 5/10 mg 19-May-93 Amlodipine Besylate BP Eq. to Amlodpine 5mg + Losartan Potassium USP mg/50mg film coated tablets Amlodipine besylate eq. to Amlodipine 5mg + Atenolol 50mg Besylate uncoated tablets

9 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 9 Amlodipine besylate Eq. to Amlodipine 5mg + Lisinoril eq. to Lisinopril anhydrous 5mg tablet Amlodipine Besylate eq.to Amlodipine 5mg + Atorvastatin calcium eq. to Atorvastatin 10mg each tablets Amlodipine Besylate IP Eq. to Amlodipine 10mg/5mg/2.5mg +Telmisartan mg/40mg/20mg + HCTZ 25mg/12.5mg/12.5mg tablet Amlodipine Orally Disintegrating Strips 2.5mg/5mg/10mg Amlodipine Tablets 5mg/10mg (additional indication) Amlodipine5mg + Ramipril10mg/5mg Tablets (additional strength) 03/10/2010 Ammoidin + Amidine Jul-67 Ammonium Lactate Cream 12% w/w Amorolfine Amoscanate 1985 to 87 Amoscanate tablet 250 mg Nov-85 Amoxapine 1985 to 87 Amoxapine tablet 25/ 50/ 100 mg Nov-85 Amoxicillin 125mg + Carbocistine 75mg per 5ml syrup Apr-91 Amoxicillin 250/500mg + Carbocistine 150mg/150mg capsule Apr-91 Amoxicillin 250mg + Lacto- Bacillus 1.7 billion Spores Amoxicillin 250mg/125mg + Cloxacillin 250mg/125mg + Lactic Acid Bacillus 1.7 Billion spores Amoxicillin Dispersible Tablet 125 mg Mar,1980 Amoxicillin trihydrate IP e.q. to Amoxicillin 400 mg Caluvulanate Potassium e.q. to Clavulanic acid 57 mg Dispersible Tablet: Each dispersible tablet contains: Amoxicillin Trihydrate IP eq to Amoxicillin 80 mg+ Potassium Clavulanate IP eq to Clavulanic Acid 11.4 mg (additional Strength) Each 1 ml of the constituted suspension contains Amoxicillin trihydrate USP e.q. to Amoxicillin 400 mg Caluvulanate Potassium e.q. to Clavulanic acid 57 mg Oral Suspension: Each 5ml of reconstituted suspension contains: Amoxicillin+ Carbocistine Apr-91 Amoxycillin Dec,1978 Amoxycillin (Present as amoxicillin trihydrate IP) 500mg + Clavulanic Acid (Present as potassium clavulanate USP) 125mg film coated tablets Amoxycillin + Clavulanic acid Feb-87 Amoxycillin + Clavulanic acid(1gm mg ) FC Tablets Amoxycillin + Sulbactum Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tablet 06/08/2006 Amoxycillin 125mg/250mg/500mg + Lactobacillus 1.66 billion Spores (Capsules) Amoxycillin 250mg + Clavulanic acid 150mg dispersible tablet Amoxycillin 250mg + Cloxacillin 250mg + Lactobacillus 2 billion spores capsules Amoxycillin 250mg + Dicloxacillin 250mg + Lactobacillus 2.5 million spores capsules Amoxycillin 250mg + Dicloxacillin 250mg cap. 28/08/06

10 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 10 Amoxycillin 500mg + Potassium Clavulanate 100mg injection Amoxycillin 500mg/1gm + Clavulanic acid 100mg/200mg each vial Injection May-87 Amoxycillin 875mg + Clavulanic Acid 125mg tablets Amoxycillin Capsule 250mg & 500mg Jan,1979 Amoxycillin Injection 250mg/500mg/1g/vial Jun,1979 Amoxycillin Oral Suspension 200/400 mg per 5ml 9/8/2010 Amoxycillin Paediatric Suspension 125mg/1.25 ml Jan,1979 Amoxycillin Sodium IP Eq. to Amoxycillin 200mg/2000mg/3000mg Sulbactam Sodium USP Eq. to Sulbactam 100mg/1000mg/1500mg 2. One ampoule of Sterile water for injection IP 5ml/15ml/15ml Each combipack contains: 1. One vial Containing: Amoxycillin Syrup 125mg/5ml & 250mg/5ml Jan,1979 Amoxycillin trihydrate 250mg + Potassium Clavulanic eq. to Clavulanic acid Feb mg each tablet Amoxycillin trihydrate IP e.q. to Amoxycillin 200 mg + Potassium caluvulanate e.q. to Clavulanic acid 28.5 mg Each uncoated dispersible tablet contains: Amoxycillin trihydrate IP e.q. to Amoxycillin 200 mg Caluvulanate Potassium e.q. to Clavulanic acid 28.5 mg Each 5ml of reconstituted suspension contains: Amoxycillin trihydrate IP e.q. to anhydrous Amoxycillin 250 mg/125 mg Caluvulanate Potassium e.q. to Clavulanic acid 62.5 mg/31.25mg Each uncoated dispersible tablet contains: Amphotericin B Emulsion 5mg/ml (Addl. Indication) Amphotericin B Lipid suspension 50mg/ vial (Addl. Strength) Amphotericin B Lipid suspension injection (25mg/vial) with lipid suspension Ampicillin + Probenecid 83/01/01 Ampicillin + Sulbactum Sep-91 Ampicillin 250mg + Dicloxacillin 250mg tablet 13/12/06 Ampicillin 3.5gm + Probenecid 1.0gm single vial Feb-83 Ampicillin Sodium 0.25/0.5gm + Sulbactum Sodium 1gm/2gm per vial Injection Ampicillin Sodium 0.5gm + Sulbactum Sodium 1gm per vial Injection Sep-91 Amrinone Lactate May-88 Amsacrine Injection Feb-92 Amtolmetin Guacil tablets 600mg Amylase + Cellulose + Protinase + Pencreatic enzyme + Lipase Capsule Dec-71 Amylobarbitone + Trifluperazine Dihydrochloride Capsule Feb-67 Anastrazole Anidulafungin Injection (Lyophilized powder) 50mg/100mg per vial Anti-Rabies Vaccine Mar-89 Apixaban Tablets 2.5/5mg (add. Indication) Apixaban Tablets 2.5mg Apixaban tablets 2.5mg/5mg (Additional Strength & Additional Indication) Apomorphine HCL-2mg/3mg Sublingual tablet Apraclonidine Ophthalmic Sol Apramycin Sulphate Aprepitant 40mg capsules (additional strength)

11 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 11 Aprepitant cap (80mg/125mg) 30/08/06 Aprotonin Nov,1973 Aprotonin Injection KIU/5ml, KIU/10ml Jan,1974 Aremther 20mg + Lumefantrine 120mg tablet Arformoterol (as Tartrate ) 15mcg / 2ml Inhalation Solution Aripiprazole Armodafinil uncoated tablet 50/150/250mg 23/04/2010 Arteether 14-Jan-97 Arteether injection 150mg/ml Arteether injection I.M. -150mg per vial 14-Jan-97 Artemether + Lumefantrine (80mg + 480mg/5ml) Dry syrup Artemether + Lumefantrine Dispersible tablet (40/80mg + 240/480mg ) (Additional Strength) Artemether 20mg + Lumefantrine 120mg Dispersible tablet (Additional Strength) Artemether 20mg + Lumefantrine 120mg Syrup Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets (additional Strength) Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets (additional Strength) Artemether 60mg +Lumefantrine 360mg (additional Strength) uncoated Tablets Artemether Capsule 40mg 3-Aug-96 Artemether Injection -80mg 2-Aug-96 Arterolane Maleate 150mg + Piperaquine Phosphate 750mg Tablet Arterolane Maleate 150mg + Piperaquine Phosphate 750mg Tablet Artesunate Aug Artesunate (25/50/100mg) + Amodiaquine (67.5 mg/135/270mg) bilayerd Tablets Artesunate 150mg/200mg + Sulphadoxine 500mg/750mg + Pyrimethamine /37.5mg Combipack Artesunate injection 60mg 2-Sep-96 Artesunate injection. Each combipack contains: "Artesunate for injection mg ( Each vial contains Artesunate IP 120mg), Sodium bicarbonate injection IP 5%w/v (Each 2ml ampoule contains: Sodium Bicarbonate IP 5% w/v), Sodium chloride Injection IP 0.9% w/v (Each 10ml ampoule contains: Sodium chloride IP 0.9% w/v)" Artesunate powder for injection 60mg/vial alongwith 6ml ampoule of phosphate buffer solution (ph 8.0;0.30M) Artesunate tabs 50mg 7-Oct-96 Arthemether Injection Aug Articaine Hydrochloride Aug-86 Asenapine Maleate Sublingual Tablets 5mg/10mg Asiaticoside Nov,1976 Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl. Strength) 22/06/2006 Aspirin 25mg+ Dipyridamole BP 200mg (ER) capsule Aspirin 75mg/75mg + Clopidogrel 150mg/150mg Tablet

12 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 12 Aspirin (EC Tablets) 75mg/75mg/150mg +Rosuvastatin (Granules) mg/10mg/10mg Capsules Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl. Strength) 22/06/2006 Aspirin 150mg + Clopidogrel 300mg Tablet (additional strength) Aspirin 150mg + ISMN 60mg SR Tablets Aspirin 75mg / 150mg + Glycine 37.5mg/75mg tablet 08/10/2006 Aspirin 75mg + Simvastatin 10mg/20mg + Lisinopril 5mg/10mg + Atenolol 1/6/ mg/50mg Tablets Aspirin Bolus (Vet.) 6gm/bolus) Astemizole Feb-88 Astemizole Susp. Aug-88 Atazanavir (100/150/200mg) 24/04/2006 Atazanavir + Ritonavir (300mg + 100mg) FC Tablets Atazanavir 150mg + Ritonavir 50mg capsules 12/12/2006 Atazanavir 300mg capsules (Additional strength) Atenolol 1985 to 87 Atenolol 25/50mg + Chlorthalidone 6.25 mg tablets Atenolol (25mg, 50mg) + HCTZ (12.5mg) Atenolol (25mg, 50mg) + HCTZ (12.5mg, 12.5 mg ) Tablet Atenolol + Amlodipine Atenolol 25mg/50mg + Indapamide SR 1.5mg Atenolol 25mg/50mg + Indapamide SR 1.5mg tablet Atenolol 50mg + HCTZ 25mg (addl. Strength) 02/03/2006 Atenolol BP 50mg + Nifedipine SR 20mg capsule Jan-90 Atenolol tablet 50 mg/ 100 mg Sep-85 Atomoxetine (as HCl) Sachet (10/18/25/40mg) Atomoxetine 60mg capsule (Addl. Strength) 27/02/2006 Atomoxetine HCl (10,18, 25 & 40mg ) capsule 9/11/2004 Atorvastatin Atorvastatin (10mg/20mg) + Ezetimibe (10mg) Tablet Atorvastatin (40mg) + Ezetimibe (10mg) Tablet (addl. Strength) Atorvastatin + Metformin (10mg + 500mg SR) Tablets Atorvastatin 10mg + Aspirin 75/150mg Capsules Atorvastatin 10mg + Fenofibrate 80mg tablet (Additional Indication) Atorvastatin 10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + 04/05/2010 Metoprolol (ER tablets) 25mg Capsules Atorvastatin 10mg/20mg + Ezetimibe10mg/10mg tablet Atorvastatin 20mg + Ramipril 2.5mg/5mg Capsules (additional strength) 17/03/2010 Atorvastatin 5/10/5mg + Telmisartan 20/20/40 mg Atorvastatin 5mg + Fenofibrate 160mg (additional strength) tablets 12/01/2006 Atorvastatin Calcium (10mg ) + Ramipril (2.5mg/5mg) tablet Atorvastatin Calcium (10mg) + Fenofibrate (145mg) (addl. strength) Atorvastatin Calcium (10mg) + Ramipril (2.5mg/5mg) tablet Atorvastatin calcium 5mg/10mg/20mg/40mg/80mg (Additional Dosage Form) 20/04/2011 Atorvastatin Calcium 80mg tablets (Additional Strength) Atorvastatin Calcium eq. Atorvastatin 10 mg + Fenofibrate (micronised) mg film coated tablets

13 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 13 Atorvastatin Calcium IP Eq. to Atorvastatin 5mg + Fenofibrate BP 145mg film coated tablet (additional strengths) Atorvastatin10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + 5/4/2010 Metoprolol (ER tablets) 25mg Capsules Atorvastin 10mg/20mg + Ezatimib 10mg/10mg tablet Atorvaststin 10mg + Nicotinic Acid 375mg/500mg (ER) Tablets Atosiban Acetate Injection 6.75mg/0.9ml and Bulk Atracurium Dibesylate Injection Jan-86 Atropine Sulphate 0.06mg + Hyoscyamine sulphate 0.30mg + Scopolamine Dec-69 hydrobromide 0.035mg + Phenobarbatal 64.8mg capsule Auranofin capsules 3 mg Dec-87 Autolysate of β-subtilis + β- megatherium Jul-75 Axitinib Tablet 1mg/5mg Azabiperidol Sep,1981 Azacitidine Azacitidine 100 mg / vial Azacitidine Lyophilized powder for Injection 100mg/vial (Intravenous or Subcutaneous) Azathioprine 1969 to 74 Azathioprine 25mg Tablets Azatidine Maleate Tablet 1 mg Nov, 1980 Azelaic acid Cream (15%) Azelaic Acid 8/7/2003 Azelastine HCL Azelastine Nasal spray 0.01gm per 10ml 15-Jul-97 Azilsartan Medoxomil Bulk & 40mg/80mg Tablets Azithromycin + Dexamethasone (10mg + 1mg) Eye Drops Azithromycin 500mg + Ambroxol S.R (75mg) Tablet 5/7/2007 Azithromycin capsules/suspension [Each capsule contains : Azithromycin 13-May-94 dihydrate equl to 250mg of base 2. Each 5ml contains: Azithromycin- 200mg/50mg] Azithromycin eye drops 1% Azithromycin SR Granules for Oral Suspension 1gm (Addl. Strength) 5/4/2010 Azithromycin Tablet 250mg/500mg Azithromycin SR Granules for oral suspension 2000mg Aztreonam For ready made Pharmaceutical Stationary like Raw Material yd@pharmadocx.com Stock Register, Control Sample Register, Production Register Etc. Contact Pharmadocx b -arteether Injection (150 mg/2 ml) 1/9/2004 Bacampicillin tablet 400 mg Oct-85 Bacillocid special May-92 Bacillus calmette guerin vaccine Jun-92 Bacillus Clausii Spores (2 Billion) Capsules (additional dosage form) Baclofen Baclofen E.R capsule (30mg)

14 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 14 Baclofen ER (GRS) Capsule 45mg/60mg (additional strength) Baclofen ER Capsule 10 mg/50 mg (Additional Strength) Balanced salt intra ocular irrigating solution enriched with glutathione Dextrose, bicarbonate Balofloxacin Tablet 100mg Balsalezide Disodium Bambuterol Basiliximab Inj Beclomethasone + Neomycin Apr-74 Beclomethasone Dipropionate Feb,1973 Beclomethasone Dipropionate 0.025% + Chinoform 3% Ointment & Cream Apr-74 Beclomethasone Dipropionate 0.025% + Neomycin Sulphate 0.5% Ointment Apr-74 & Cream Beclomethasone Dipropionate 0.025% cream & ointment Apr,1974 Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg per gm of Cream Beclomethasone Dipropionate IP 100mcg + Formoterol Fumarate Dihydrate BP Eq. to Formoterol Fumarate 6 mcg Metered Dose Inhaler Beclomethasone Dipropionate IP 0.025% w/w + Neomycin sulphate IP 0.5% w/w cream Beclomethasone Dipropionate MDI 50 mcg Dec,1975 Bedaquiline Tablet 100 mg Bemiparin Sodium Solution for injection (5000/7500/10,000 I.U) Benazapril + HCTZ Benazapril Hcl 5mg/10mg/20mg/20mg+ Hydrochlorothiazide mg/12.5mg/12.5mg/25 mg tablet Benazepril Hcl Nov Benazepril Hcl tabs 5mg/10mg/20mg 22-Apr-96 Bendamustine Hydrochloride Injection 100mg/vial (Additional Indication) 18/05/2011 Bendamustine Hydrochloride lyophilised injection 25mg (Additional strength) Bendamustine Hydrochloride Lyophilized powder Injection 100mg/ vial Bendrofluazide Benidipine Hcl tabs 4mg/8mg 12-Aug-96 Benorylate Dec,1978 Benorylate Suspension 2g/5ml Dec,1978 Benorylate Tablet 250 mg Dec,1978 Benoxinate Hydrochloride oph. Solution Nov-92 Benserazide Hydrochloride 1985 to 87 Benzafibrate retard tablet 400 mg Apr-93 Benzoyl peroxide 10%w/w + Precipitated Sulphur 5%w/w per 20gm cream Aug-75 Benzoyl Peroxide Medicated Solution (each textured pad contains %/6.5%/8.5% of solution Benzydamine Apr-88 Bepotastine Besilate Bulk Bepotastine Besilate Bulk & Bepotastine Besilate 1.5 %w/v Ophthalmic solution

15 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 15 Besifloxacin Ophthalmic Suspension 0.6% w/v Betacarotene + Vitamin + Selenium Betahistine Di hydrochloride CR capsule 24/32/48mg Betahistine Dihydrochloride SR Tablets 24mg/32mg/48mg Betahistine Dihyrochloride Apr,1975 Betahistine Mesilate Tablet 6mg/12mg Betamethasone 0.05% +Miconazole 2% Cream Betamethasone Diprop 0.064%+ Salicylic acid-3% each ml lotion Betamethasone Diprop mg+Gentamycin Sulphate Eq to Gentamycin mg per ml spension Lotion Betamethasone Dipropionate to 7/1981 Betamethasone Dipropionate 6.43 mg + Betamethasone Sodium Phosphate Jul mg each vial Betamethasone Dipropionate Ointment 0.5mg/g Sep, 1979 Betamethasone-17-benzoate Dec,1973 Beta-methyl Digoxin Dec,1977 Beta-methyl Digoxin Injection 0.1 mg Mar,1978 Beta-methyl Digoxin Liquid 0.6 mg Mar,1978 Beta-methyl Digoxin Tablet 0.1 mg & 0.05 mg Mar,1978 Betaxolol Hydrochloride ophthalmic 0.5 %W/V/ 5 ml May-92 Beverine Hydrochloride Tablets, 50mg Mar,1971 Bezafibrate Jan-88 Bicalutamide Bicalutamide Tablet 150 mg.(additional Strength and Indication) Biclotymol 1985 to 87 Biclotymol 0.150gm + Glyceryl Galacolate 0.200gm+Pholcodine May gm+Chlorphenaramine maleate 0.01gm per 100ml (for children) Biclotymol 0.198gm + Glyceryl Galacolate 0.200gm + Pholcodine 0.133gm+ May-86 Chlorphenaramine maleate gm per 100ml Syrup (for adult) Bifonazole Bifonazole cream/solution/powder [1gm of cream/powder contains Bifonazole-0.01gm and 1ml of solution contains Bifanazole-0.01gm] Bimatoprost 300mg + Timolol (as maleate) 5mg/ml eye drops 07/05/2006 Bimatoprost (Opthalmic Solution) Bimatoprost 0.3mg + Timolol Maleate IP Eq. to Timolol 5.0mg eye drops Bimatoprost Eye Drps 0.1mg/ml 5/8/2010 Bimatoprost Ophthalmic Solution 0.01% w/v (Additional Strength) Bimatoprost (Ophthalmic Sol.) Bimatoprost Opthalmic solution 0.03% Bioceramic composite materials: a) Each glass vial contains; Hydroxyapatite % granules b) each glass contains: hydroxyapatite 90% granules +β tri clacium phosphate 10% granules c) Each vial contains: Hydroxyapatite paste as 30% and 18% suspension Biperiden lactate Injection 5 mg Oct,1972 Biperlden Hydrochloride 1969 to 74 Biphenyl acetic acid gel -3.00%w/w 27-Apr-98 Bisoprolol Fumarate Feb-92

16 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 16 Bisoprolol Fumarate (2:1) 2.5mg/5mg+ Hydrochlorthiazide -6.25mg/6.25 mg Tablet Bivalirudin Injection (250mg/vial) Bleomycin Dec,1973 Bleomycin Injection Feb-87 Bleomycin Injection 5 mg Oct,1978 Bleomycin Oil Suspension injection. Sep-85 Blonanserin Tablet 2mg/4mg/8mg Bortezomib 2mg/vial (additional pack size) Bortezomib for injection (3.5mg/vial) Bortezomib for injection 3.5mg (Sub-cutaneous route of administration as an alternate to intravenous route) (Additional route of administration) Bortezomib inj.3.5mg/vial (Additional Indication) Bortezomib Injection (additional indication) Bosentan (as monohydrate) Tablets 62.5/125mg Boswellia Serrata 0.05gm/gm of Cream Botulinum toxin type A 50 Units/Vial and 100 Units/Vial (Additional 2/6/2011 Indication) Botulinum Toxin.A 100 unit [Each Vial contains Clostridium botulinum toxin 13-Jan-94 type-a - Hemagglutinin Complex 100units. Human. Serum albumin-0.5mg Nacl-0.9mg] Brimonidine Tartrate Brimonidine Tartrate (2mg/1.5mg) + Timolol (as HCl) (5mg/5mg per) ml Brimonidine Tartrate Opthalmic solution 0.1% (with purite as preservation %) (additional strength) Brimonidine topical gel 0.33%(Add. Dosage form/indication) Brimonidine Tartrate Brin zolamide - 1.0% w/v Timolol maleate 0.683% w/v Eq. to Timolol 0.5% w/v Ophthalmic suspension Brin zolamide 10mg Brimonidine Tartrate eq. to Brimonidine 2mg Ophthalmic suspension Brinzolamide Ophthalmic Suspension 1%w/v Bromfenac Sodium Eye Drop (0.09%) Bromhexine Hydrochloride 3/1979 to 7/1981 Bromhexine Hydrochloride Elixir 4mg/5ml Sep, 1979 Bromhexine Hydrochloride Tablet 8 mg Sep, 1979 Bromocriptine Mesylate 1985 to 87 Bromocriptine Mesylate tab. 2.5 mg, 5 mg and 10 mg Jul-87 Bromocriptine Mesylate Tablet IP 0.8mg, (additional Indication) Broncho-Vaxom Feb, 2001 Broncospasmin elixir 10 mg/ 5ml Oct. 87 Broncospasmin injection 0.09 mg/ml Oct. 87 Broncospasmin respiratory solution 10 mg/ml oct.87 Broncospasmin tablet 20 mg Oct. 87 Bronopol (2-Bromo-2-nitroman-1, 3-diol) Broxyquinoline + Brobenzoxalidine May-63 Buclizine Hcl 25mg Tablet (Additional Indication) 16/01/2010

17 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 17 Buclizine HCl tablet (25mg) & Syrup 6mg/5ml 28/06/2006 Budesonide Feb-88 Budesonide + Formoterol (80/160mcg + 4.5mcg) Inhalational Powder (Additional Indication) Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Indication) Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Strength) Bulaquine compound Bumetanide 3/1979 to 7/1981 Bumetanide 0.5mg+Potassium Chloride 523 mg tablet Jan-83 Bumetianide Injection 0.25 mg/ml Aug, 1980 Bumetianide Tablet 1 mg Aug, 1980 Bupivacaine Hydrochloride Hyperbaric solution 10mg/ml Dec,1974 Bupivacine Hydrochloride Sep,1972 Buprenorphine 1985 to 87 Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tablet 04/06/2005 Buprenorphine + Naloxone (2 mg/0.4mg + 0.5/0.1 mg) Tablets Buprenorphine HCl eq.to. Buprenorphine 2mg + Naloxone Hcl eq.to Naloxone 0.5mg sublingnal tablets Buprenorphine sublingual tablets 0.2 mg Dec.87 Buprenorphine Transdermal Patch Each Transdermal Patch having an area of 6.25cm², 12.5cm², and 25cm²contains: Buprenorphine 5mg/10mg/20mg having release rate of 5mcg, 10mcg, 20mcg Buprenorphine per hour respectively(over a period of 7 days). Bupropion SR Buserelin Acetate (Lutenizing Hormone) Apr-86 Buserelin Acetate injection 1mg/ml (Additional Indication) Buserlin Acetate 1985 to 87 Buspirone HCl Oct-90 Butafostane 10gm + Cyanocobalamine 0.005gm per 100ml Solution Butalex Apr-91 Butaphosphan 100g + Methyl Hydroxybenzoate 1gm + Cyanocobalamin gm Oral powder (Veterinary Drug) Butarphenol tartrate 10mg/ml nasal spray Butarphenol Tartarate Butenafine HCl 0mg + Betamethasone Dipropionate eq. to Betamethasone mg cream Butenafine HCl cream Surgical dressing Rs. 1 lac Cabazitaxel Injection 60mg / 1.5ml Cabergoline

18 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 18 Cabergoline 1 mg/2 mg/4 mg tablets 7/5/2004 Cabergoline 1mg tablet (additional strength) Cabergoline 1mg Tablets (Additional indication) Caffeine 100mg + Ergotamine tartrate 1mg + Analgin 250mg + Mar-76 Trifluperazine HCl 1mg Capsule Caffeine Citrate 20mg / ml (equivalent to 10mg of Caffeine base) Oral Solution (Addl. Dosage form) Caffeine(as Citrate) 10mg / ml Injection Calamine 8% + Liquid Paraffin10% lotion Calcipotriol 50mcg + Betamethasone 0.5mg Ointment Calcipotriol Gel 0.005% (additional dosage form) Calcitriol 0.25mcg + Calcium 200mg + Zinc 7.5mg Capsules Calcitriol + Calcium + Zinc (0.25mcg + 200mg + 7.5mg) Capsules Calcitriol Inj Calcitriol Soft Gelatine Caps 0.5mcg & 0.25mcg 27-Aug-93 Calcium (as Calcium Citrate Malate) + Colecalciferol (as Colecalciferol Concentrate) + Folic Acid (250mg + 100IU + 50mcg) Tablets Calcium (as Calcium Citrate Malate) + Colecalciferol (as Colecalciferol Concentrate) + Folic Acid (250mg + 100IU + 50mcg) Tablets Calcium acetate 435mg + Magnesium carbonate 235mg tablets 03/05/2010 Calcium and Magnesium 24% (Veterinary) injectable solution Calcium carbonate 600mg +Simethicone 80mg Chewable tablet 28/05/2010 Calcium citrate maleate Eq.to elemental calcium 250mg +Vitamin D3 IP IU tablet Calcium Dobesilate caps -500mg Calcium gluconate 50mg + Iso thipendyl HCl 4mg + Acetylsalicylic acid 200mg + Caffine 30mg per dosage 22-Sep-97 Jun-72 Calcium Hypochlorite 4gm Sachet (Calcium Hypochlorite 0.542% Other Ingredients: %) Calcium Pidolate equivalent to Calcium 500mg + Vit-D3 250 IU powder for oral use Calcium Pidolate equivalent to Calcium 500mg + Vit-D3 250 IU Calcium Polycarbophil (500mg) Tablet 6/7/2005 Calender pack containing 21 days1. Levonorgestrel 0.05mg + Jun-81 Ethinyloestradiol 0.03mg Tablet 2. Levonorgestrel 0.075mg + Ethinyloestradiol 0.04mg Tablet 3. Levonorgestrel 0.125mg + Ethinyloestradiol 0.03mg Tablet and 7 inactive tablets extra Calf lung surfactant Intratracheal Suspension containing Phospholipids... 35mg (containing 26 mg phosphatidylcholine of which 16mg is disaturated phosphatidylcholine) Proteins mg (including 0.26mg of surfactant associated proteins B) per ml Camostat Mesylate tablets 100mg Canagliflozin Tablet 100/300mg Candesartan Candesartan Cilexetil- 16mg+ Hydrochlorothiazide -12.5mg tablet Candur P. Parvovirus Jul-92

19 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 19 Canine Distemper Nov-86 Cape aloes 16mg + Podophyllin resin 4.2mg + Licorice powder mg per Oct-72 Tablet Capecitabin Tablet (150mg/500mg). (for additional indication) Capecitabine Capecitabine 150/500mg Tablets (addl. Indication) Captopril 1985 to 87 Captopril 25/50mg + HCTZ 15/25mg Jul-89 Captopril tablet 25/50 mg Oct-85 Carbadox 1975 to 76 Carbencillin Sodium 1969 to 74 Carbencillin Sodium Injection 1 g vial Aug,1973 Carbenoxolone sodium 1969 to 74 Carbenoxolone sodium Tablet 50 mg Jan,1974 Carbidopa (Anhydrous) 50mg + Levodopa-200mg C.R.tablet Carbocaine injection 2 % -20 mg Feb.87 Carbocisteine 1985 to 87 Carboinoxamine Maleate + Ammonium Chloride + Sodium Citrate (Each ml contains: 2 mg mg mg) syrup Carboinoxamine Maleate + Ammonium Chloride + Sodium Citrate (Each ml contains: 2 mg mg mg) syrup Carboplatin Mar-89 Carboprost Tromethamine 1985 to 87 Carboprost Tromethamine Sterile Solution 250 mcg/ml Mar, 1979 Carboquone 1985 to 87 Carboquone inj. 1 mg/ vial Aug-85 Carboquone tablet 0.25 mg/ 0.5 mg Aug-85 Carboxy Methyl Cellulose Sodium Lubricant Eye Drops 0.5% w/v (Unit dose pack without preservative) Carenecaine 2% with Adrenaline & Carenecaine 4% with Adrenaline Feb-87 Injection Carfilzomib Sterile Lyophilized powder for Injection 60 mg/vial Carmustine (polifeprosan 20 with carmustine Implant (Wafer) Carmustine for inj. 100 mg 10/6/2010 Caroverine cap. 20mg & Inj. 40mg/2ml 23/08/06 Carteolol Hcl opthalmic solution 2% w/v 9-Jul-96 Carteolol Hcl tabs 5mg, 9-Jul-96 Carvedilol 12.5/25mg tablet 16-Oct-98 Carvedilol Phosphate ER tablet 10/20/40/80mg Carvedilol Tablets 3.125/6.25/12.5/25mg (additional indication) Caspofungin Acetate injection (50mg/70mg per vial) Caspofungin acetate Injection (Addl. Indication) Catalin (Sodium 1-hydroxy-5-oxo-5H-Pyrido(3.2-a) phenoxazine-3- Jan,1976 carboxylate) Cefaclor Apr-91 Cefadroxil Feb-89 Cefadroxil oral suspension 125/250 per 5 ml Feb-89

20 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 20 Cefadroxil (as monohydrate) 125mg + Clavulanic acid (as potassium) per 5ml Syrup (Additional strength) Cefadroxil 500 mg + Clavulanic acid 125 mg tablet Cefadroxil 500mg/250/250+Clavulanic acid 125/62.5/62.5 mg film coated tablet. Dispersible tablet, dry syrup ( each 5 ml contains) Cefadroxil tablet/ capsule 500mg/ 1 gm Feb-89 Cefalexine + Bromhexine Cefataxime sodium 500 mg + sulbactum 250 / 500 mg inj Cefazolin Sodium inj. 250 mg, 500 mg & 1 gm. per vial Sep-85 Cefdinir Cefdinir 250mg dispersible tablets & oral suspension 250mg/5ml Cefdinir Dispersible tablet (125mg) Cefditeron (as pivoxil) 200mg tablet 3/3/2006 Cefditoren pivoxil 400mg tablets (Additional Strength) Cefditorene pivoxil dispersible tablet (30mg/50mg) (New Dosage form for children) Cefepem (as Hcl) 0.5/1gm/2gm + Amikacin (as sulphate) /0.250/0.5gm Injection Cefepem (as Hcl) 0.5/1gm + Amikacin (as sulphate) 0.125/0.250gm Inj. 11/8/2006 Cefepime (250mg) + Tazobactam (31.25mg) Injection (addl. Strength) Cefepime (As Hcl) 500mg/1000mg + Tazobactum (as Sodium) 30/08/ mg/125mg per injection Cefepime (as hydrochloride) 2000/1000/500mg + Sulbactam (as sodium) /500/250mg per vial of injection Cefepime Injection (New indication) Cefepime injection 500mg/1gm/2gm (For additional indication) Cefepine HCl Cefetamet Pivoxil Hcl oral suspension 250mg/ml 16/02/2006 Cefetamet Pivoxil Suspension 250 mg/5ml 9/8/2004 Cefetemet-piroxil Cefixime Mar-93 Cefixime (50mg/100mg) + Clavulanic acid mg/62.5mg per ml dry 29/08/06 syrup & tablet Cefixime (SR) 400mg +Moxifloxacin (SR) 400 mg Tablets Cefixime 100mg/200mg + Cloxacillin (as Sodium) 500mg/500mg + 31/08/06 Lactobacillus (45 /90 Million spore) tablet Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tablets 12/2/2010 Cefixime 100mg/200mg + Ofloxacin 100mg/200mg Tablets 26/04/2010 Cefixime 200 mg + Dicloxacillin ER 500 mg Tablets Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90 million Spore 14/11/06 tab. (additional strength) tablet Cefixime 200mg + Pot. Clavulanate (125mg) tablet 20/07/2006 Cefixime 200mg/100mg + Lactic acid bacillus 2.5 billion spores tablet & dispersible tablet Cefixime capsules 100mg/200mg/400mg Cefixime dispersible tablet 400mg (new dosage Form) 22/11/06 Cefixime SR 200mg/400mg + Ofloxacin SR 200mg/400mg Tablet

21 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 21 Cefixime Tablets 200mg & Cefixime Oral Suspension 100mg/5ml Cefixime Trihydrate IP Eq. to Anhydrous Cefixime 100mg/200mg Ofloxacin IP 100mg/200mg Dispersible Tablet (Additional dosage form ) Cefoperazone + Sulbactum Cefoperazone 500/1000mg + Tazobactum 62.5/125mg Injection Cefoperazone sod. Eq. to Cefoperazone 1g/2g + Sulbactum Sod. Eq. to Sulbactum 0.5g/1g each vial Injection Cefoperazone sodium injection IM/IV Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As sodium) 250mg/500mg injection (for additional indication) Cefotaxime sodium 1985 to 87 Cefotaxime sodium + Sulbactam sodium for injection (Additional Indication) Cefotaxime Sodium injection 0.25, 0.5, 1 and 2 gm./ vial Jun-87 Cefovecin( as sodium) 80mg/ ml Lyophilised powder for injection (Veterinary) Cefpirome Cefpirome (as sulphate) 500/1000mg/2000mg + Sulbactam (as sodium) mg/500mg/1000mg powder for injection Cefpirome injection 0.25g/0.5g/1.0g/2gm per vial 26-Sep-97 Cefpodoxime (as Proxetil) (100mg/200mg) + Clavulanic acid (62.5/125mg) tablet. Cefpodoxime 100/200mg + Dicloxacillin ER 500/500mg Tablet 08/06/2010 Cefpodoxime 100mg + Clavulanate Potassium 62.5 mg Dispersible Tablet/Dry Syrup Cefpodoxime 100mg + Ofloxacin 100mg Dispersible Tablet (Additional Dosage form) Cefpodoxime 200/100mg + Clavulanate Potassium 125/62.5mg Tablets Cefpodoxime 50mg + Clavulanic acid 31.25mg dispersible tablet & dry syrup (Additional strength) Cefpodoxime IP 100mg/100mg/200mg/200mg + Ofloxacin IP mg/200mg/100mg/200mg Tablets Cefpodoxime Proxetil Cefpodoxime Proxetil Sept Cefpodoxime Proxetil tab/syrup [Each tab contains, Cefpodoxime Froxetil- 19-Sep mg, Each 5ml suspension contains Cefpodoxime Proxetil-40mg] Cefprozil Cefprozil 250mg/500mg + Clav. Acid-62.5mg /125mg. Tab Cefprozil Dispersible Tablet (125 mg/ 250 mg) Cefprozil Powder for oral suspension (125mg/5ml) Ceftaroline Fosamil Injection 600 mg/vial Ceftazidime 250mg + Tazobactam 31.25mg Injection Ceftazidime 500mg + Tobramycin 60mg per vial (Injection) Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For injection Ceftazidime + Sulbactam (500/1000mg + 250/500mg) Injection Ceftazidime + Tobramycin injection (1gm + 120mg) (Additional Strength) Ceftazidime 500mg + Tobramycin 60mg per injection

22 LIST OF NEW DRUGS 1961 MAY 2017 download from Page - 22 Ceftazidime 500mg /1000mg + Tazobactum (as sodium) 62.5mg/125mg per 30/08/06 vial for injection Ceftazidime 500mg + Tobramycin 60mg per vial (Injection) Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For injection Ceftazidime Pentahydrate Jun-88 Ceftazidine (2gm) + Sulbactam (1gm) Injection (addl. strength for additional 9/6/2007 indication) Ceftibuten (Finished formulation) Nov, 1996 Ceftibuten Capsule/Suspension [Each capsules contains ceftibuten 19-Nov mg/400mg Each 5ml suspension contains ceftibuten 90mg/180mg ] Ceftiofur Crystalline free acid Suspension equi to Ceftiofur mg(veterinary) Ceftiofur HCl Suspension (as HCl salt) mg (veterinary) Ceftiofur HCl Suspension(as HCl salt) mg (veterinary) Ceftiofur Sodium & Ceftiofur HCl Ceftizoxime Sod. Sterile May-90 Ceftriaxone 2gm+ Tazobactum 250mg for injection Ceftriaxone (as sodium) (500mg/1000mg) + Sulbactam (as sodium) 12/08/2005 (250mg/500mg) powder for injection Ceftriaxone (as sodium) (500mg/100mg) + Tazobactum (12.5mg/62.5mg) injection Ceftriaxone (As sodium) 125mg/250mg + Sulbactam (As sodium) mg/125mg For injection (additional strength) injection Ceftriaxone (as sodium) 250mg + Tazobactam mg for injection (addl. 07/05/2006 Strength) Ceftriaxone + Sulbactam injection (Additional Indication) Ceftriaxone 0.125/0.25/0.5/1g + Tazobactam /31.25/62.5/125mg injection Ceftriaxone 2gm + Sulbactam 1gm injection (Additional Indication) Ceftriaxone 2gm+ Tazobactum 250mg for injection Ceftriaxone sodium Apr-88 Ceftriaxone Sodium eq. to Ceftriaxone Sodium 1000mg/2000mg + Sulbactam Sodium eq. Sulbactam 500mg/1000mg.injection Cefuroxime Jun-88 Cefuroxime 250mg + Clavulanic Acid 125mg FC tablet/dry syrup Cefuroxime Axetil May-90 Cefuroxime Axetil (250mg) + Clavulanic Acid (125mg) Tablet Cefuroxime Axetil ER tablets (500 mg/1000mg) 6/10/2004 Cefuroxime injection 250 mg/ 500 mg / 1 gm. per vial Jun-88 Cefuroxime Sodium 250mg intramammay infusion for Veterinary (PFS) (New 13/12/2011 dosage form) Cefuroxime Sodium 750/1500mg + Sulbactam Sodium 375/750mg Injection 07/06/2010 Cefuroxime-125/250/500mg +Clavulanic Acid-31.25/62.5/125mg film coated 10/05/2007 tablet Celecoxib Celecoxib 100/200mg +Diacerein 50/50mg 19/07/10