New Delhi, the 18 th December, 2017 ORDER

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1 (Published in Part II, Section 3, Sub-section (ii) of the Gazette of India, Extraordinary) Government of India Ministry of Chemicals and Fertilizers Department of National Pharmaceutical Pricing Authority ORDER New Delhi, the 8 th December, 207 S. O. 395(E) In exercise of the powers conferred by paragraphs 5, and 5 of the Drugs (Prices Control) Order, 203, read with S.O. 394(E) dated the 30 th May, 203 and S. O. 70(E) dated 0 th March, 206 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), hereby fixes, the price as specified in column (6) of the table herein below as the retail price, exclusive of goods and services tax, if any, in relation to the formulation specified in the corresponding entry in column (2) of the said Table with the strength, unit and name of manufacturer & marketing company, as specified in the corresponding entries in columns (3), (4) and (5) thereof; Sl. No. Name of the Scheduled Formulation / Brand Name. Ferrous Ascorbate + Folic Acid + Cyanocobalamin + Zinc Sulphate Monohydrate tablet (Autrin - XT) 2. Rosuvastatin + (Roseday CV 0) 3. Teneligliptin + Metformin tablet (Ten20 M 000) 4. Clobetasol + Clotrimazole + Neomycin Sulphate Cream Table Strength Unit Manufacturer & Marketing Company Each film coated tablet Ferrous Ascorbate eq. to Elemental Iron 00mg, Folic Acid IP.5mg, Cyanocobalamin IP 5 mcg, Zinc Sulphate Monohydrate IP eq. to Elemental Zinc 22.5mg Rosuvastatin (As granules) 0mg, Bisulphate IP eq. to (As a film coated tablet) 75mg s hydrate eq. to Teneligliptin 20mg, Metformin HCL 000mg (as extended release) Each gm Clobetasol Propionate IP 0.05%w/w, Clotrimazole IP.00% w/w, Neomycin Sulphate IP 0.50%w/w M/s Tirupati Medicare / M/s Pfizer M/s Aeon Formulation Pvt. / M/s USV Private M/s Glenamark / M/s Centaur Pvt. GM M/s Mankind Pharma / M/s Pharma Force Lab. Retail Price (Rs.) Moxifloxacin + Each Coated Sustained Release M/s Akums Drugs

2 Cefixime s (Moximac Plus) 6. Moxifloxacin + Cefixime s (Macflox Plus) 7. Tramadol + Paracetamol 8. Rosuvastatin + Aspirin + 9. Teneligliptin + 0. Teneligliptin +. Paracetamol + Caffeine + Phenylephrine + Diphenhydramin e 2. Ramipril + 3. Teneliglitptin + tablet Moxifloxacin Hydrochloride BP eq. to Moxifloxacin 400mg, Cefixime IP (as trihydrate) eq. to Ahydrous Cefixime 400mg Each Coated Sustained Release tablet Moxifloxacin Hydrochloride BP eq. to Moxifloxacin 400mg, Cefixime IP (as trihydrate) eq. to Ahydrous Cefixime 400mg Each Film Coated tablet Tramadol Hydrochloride IP 37.5mg, Paracetamol IP 325mg Each film coated bilayered tablet Rosuvastatin 0mg, Aspirin IP 75mg, Bisulphate IP eq. to 75mg s hydrate eq. to Teneligliptin 20mg, Metformin HCL 500mg (as extended release) s hydrate eq. to Teneligliptin 20mg, Metformin HCL 000mg (as extended release) Each uncoated tablet Paracetamol IP 500mg, Caffeine (Anhydrous) IP 30mg, Phenylephrine Hydrochloride IP 5mg, Diphenhydramine Hydrochloride IP 25mg Each uncoated tablet Ramipril IP 5mg, Besilate IP eq. to 5mg Each Film uncoated bilayer tablet Teneliglitptin Hydrobromide Hydrate 20mg eq. to Tenegliptin 20mg, Metformin Hydrochloride IP 000mg (In Sustained Release form) and / M/s Macleods M/s Akums Drugs and / M/s Macleods M/s Anglo French Drugs & Industries M/s Safetab Life Science / M/s Intas M/s Synokam Pharma limited/ M/s Cadila Pharmceuticals M/s Synokam Pharma limited/ M/s Cadila Pharmceuticals M/s Biochem Pharmaceutical Industries M/s Lupin 4. tablet M/s Lupin / M/s Unichem Laboratories Teneliglitptin + Each uncoated bilayer tablet M/s Lupin /

3 5. Rosuvastatin + (Roistar CV 0/75) 6. Rosuvastatin + (Roistar CV 20/75) 7. Diclofenac 8. Teneligliptin + (EFIGLIN M) 9. Rosuvastatin Rosuvastatin + (Roseday CV 20) 2. Teneligliptin Teneligliptin Metformin + Glimepiride + Voglibose Metformin Hydrochloride IP 500mg Rosuvastatin 0mg (As Pellets), Bisulphate IP eq. to 75mg (as Pellets) Rosuvastatin 20mg (As Pellets), Bisulphate IP eq. to 75mg (as Pellets) Each ml Diclofenac Sodium IP 75mg Each uncoated Bilayered tablet Metformin HCl 500mg Rosuvastatin 20mg (As granules), Bisulphate IP eq. to 75mg (as to film coated tablets) Rosuvastatin (As Pellets) 20mg, Bisulphate IP eq. to (As Pellets ) 75mg Each uncoated bilayer tablet Metformin HCL 500mg (as sustained release) Each uncoated bilayer tablet Metformin HCL 000mg (as sustained release) Each tablet Metformin HCL 500mg (as sustained release form), Glimepiride 2mg, M/s Unichem Laboratories Ltd / M/s Unichem Laboratories / M/s Unichem Laboratories ML M/s Cadila Healthcare / M/s MedoPharm, M/s GKM New Pharma / M/s Cadila Healthcare / M/s USV Pvt. Ltd, / M/s Emcure /s Synokem / M/s Emcure M/s Sunglow Pvt. / M/s Intas

4 Voglibose 0.3mg 24. Paracetamol 25. Aceclofenac + Paracetamol 26. Rosuvastatin Teneligliptin + (EFIGLIN M 000) 28. Olmesartan Telmisartan + Metoprolol (Xstan-Beta 25mg) Each tablet Paracetamol IP (as Immediate Release) 300mg, Paracetamol IP (as Sustained Release) 700mg Each Aceclofenac IP 00mg, Paracetamol IP 325mg Each Hard gelatin capsule Rosuvastatin 0mg, 75mg Each uncoated Bilayered tablet Metformin Hydrochloride IP 000mg (as Sustained Release form) Each film coated tablet Olmesartan Medoxomil IP 20mg, Besylate IP eq. to 5mg, Each film coated tablet Telmisartan IP 40mg, Metoprolol Tartrate IP 25mg (ER) M/s Pure and Cure Healthcare Pvt. / M/s Strassenburg M/s Rivpra Formulation Pvt. / M/s Cadila / M/s Cadila / M/s MedoPharm / M/s Zuventus Healthcare M/s Akums Drugs and / M/s Blue Cross Laboratories Pvt Telmisartan + Metoprolol (Xstan-Beta 50mg) 3. Voglibose + Glimepride Atorvastatin + s (Atchol CV 0mg) 33. Voglibose + Glimepride + Each film coated tablet Telmisartan IP 40mg, Metoprolol Tartrate IP 50mg (ER) Voglibose IP 0.2mg, Glimepride IP mg, Metformin HCL IP 500mg (SR) Atorvastatin Calcium eq. to Atorvastatin (as pellets) 0mg, (as pellets) 75mg. M/s Akums Drugs and / M/s Blue Cross Laboratories Pvt. 0 s 0 M/s Windlas Biotech Pvt. / M/s Zuventus Healthcare / M/s Aristo Pvt. M/s Windlas Biotech Pvt

5 34. Teneligliptin + (Tenephron M) 35. Teneligliptin + (Tenephron M Forte) 36. Teneligliptin + (TYTIN M) 37. Tacrolimus 38. Telmisartan Telmisartan + (Tigatel AM 40) 40. Cefixime + Ofloxacin (Ranixime Plus) 4. Teneligliptin + (Glypte M) Voglibose IP 0.2mg, Glimepride IP 2mg, Metformin Hydrochloride IP 500mg (SR) Metformin Hydrochloride 500mg (SR) Metformin HCl 000mg (SR) hydrate eq. to Teneligliptin 20mg, Metformin Hydrochloride 500mg (as extended release) Each Hard gelatin capsule Tacrolimus IP 0.25mg Each uncoated bilayer tablet Contains: Telmisartan IP 80mg, Besilate IP 5mg Each film coated tablet Telmisartan IP 40mg, Besylate IP eq. to 5mg Each film coated tablet Cefixime Trihydrate eq. to Cefixime Anhydrous IP 200mg, Ofloxacin IP 200mg Each film coated tablet Metformin Hydrochloride 500mg /M/s Zuventus Healthcare M/s Windlas Biotech / M/s Abbott India M/s Windlas Biotech / M/s Abbott India / M/s Wockhardt 0 M/s Emcure Ltd, M/s J. K. Print Packs / M/s Mankind Pharma M/s Sun Pharma Laboratories M/s Theon / M/s Sun Pharmaceutical Industrial M/s Precise Chemipharma Pvt. / M/s Franco India Private Teneligliptin + (Glypte M Forte) 43. Glemipiride + (Ziglim M Forte) Each film coated tablet Metformin Hydrochloride 000mg Glemipiride IP mg, Metformin Hydrochlorde IP 000mg (as SR form) M/s Precise Chemipharma Pvt. / M/s Franco India Private M/s Inventia Healthcare Pvt. / M/s FDC

6 44. Glemipiride + (Ziglim M2 Forte) 45. Diclofenac 46. Doxorubicin (Pegylated Liposomal) 47. Telmisartan + Indapamide 48. Paracetamol + Mefenamic Acid (Zydol- P DS) 49. Paracetamol + Phenylephrine + Chlorpheniramin e + Sodium Citrate + Menthol 50. Atorvastatin + (Atocor CV) 5. Tacrolimus 52. Atorvastatin + (Avas 0 Gold) 53. Atorvastatin + (Astin 0 Gold) Glimepiride IP 2mg, Metformin Hydrochlorde IP 000mg (as SR form) Each ml Diclofenac Sodium IP 75mg/ml Each ml Doxorubicin HCL 2mg (Pegylated Liposomal) water for Telmisartan IP 40mg Indapamide IP.5mg Each 5ml Paracetamol 250mg Mefenamic Acid 00mg Each 5ml Paracetamol 25mg Phenylephrine Hydrochloride IP 5mg, Chlorpheniramine Maleate IP 0.5mg, Sodium Citrate IP 60mg, Menthol IP mg Atorvastatin Calcium IP eq. to Atorvastatin 0mg (As film coated tablet), Bisulphate IP eq. to 75mg (As 2 film coated 37.5mg each tablet) Tacrolimus premix (20%) eq. to Tacrolimus IP 0.25mg Each capsule Atorvastatin Calcium IP eq. to Atorvastatin 0mg (As film coated tablet) Bisulphate IP eq. to 75mg (As 2 film coated 37.5mg each tablet) Each capsule Atorvastatin Calcium IP eq. to Atorvastatin 0mg (As film coated tablet), Bisulphate IP eq. to 75mg (As 2 film coated 37.5mg each tablet) tablet M/s Inventia Healthcare Pvt. / M/s FDC ml M/s Zydus Healthcare ml M/s Natco Pharma M/s Windlas Biotech Pvt. / M/s Mankind Pharma ml M/s Akums Drugs & / M/s Jenburkt ml M/s Relax / M/s Magnet Labs Pvt M/s Windlas Biotech Pvt. / M/s Dr. Reddy s Laboratories M/s Intas M/s Micro Lab M/s Micro Lab

7 54. Glimepiride + (DIAPRIDE M 0.5) 55. Telmisartan + Hydrochlorothiaz ide (Tigatel H 40) 56. Telmisartan + Hydrochlorothiaz ide (Tigatel H 80) 57. Telmisartan + (Tigatel AMH 40) 58. Telmisartan + (Tigatel AMH 80) 59. Sofosbuvir + Velpatasvir 60. Methylprednisolo ne 6. Methylprednisolo ne 62. Methylprednisolo ne 63. Bortezomib (BortiRel) Glimepiride IP 0.5mg, Metformin Hydrochloride IP 500mg (SR) Each uncoated tablet Telmisartan IP 40mg, Hydrochlorothiazide IP 2.5mg Each uncoated tablet Telmisartan IP 80mg, Hydrochlorothiazide IP 2.5mg Each uncoated tablet Telmisartan IP 40mg, Besylate IP Eq. to 5mg, Hydrochlorothiazide IP 2.5mg Each uncoated tablet Telmisartan IP 80mg, Besylate IP Eq. to 5mg, Hydrochlorothiazide IP 2.5mg Each film coated tablet Sofosbuvir 400mg, Velpatasvir 00mg Each Vial Methylprednisolone Sodium Succinate USP. Eq. to Methylprednisolone 25mg Each Vial Methylprednisolone Sodium Succinate USP. Eq. to Methylprednisolone 500mg Each Vial Methylprednisolone Sodium Succinate USP. Eq. to Methylprednisolone 000mg Each vial Bortezomib IP 3.5mg M/s Micro Lab M/Sun Pharma Laboratories M/Sun Pharma Laboratories M/s Sun Pharma Laboratories 0 28 tablets M/s Sun Pharma Laboratories M/s Hetro Lab / M/s Emcure Pharmaceutical Vial M/s Aqua Vitoe Laboratories / M/s Claris Injectable, Vial M/s Aqua Vitoe Laboratories / M/s Claris Injectable, Vial M/s Aqua Vitoe Laboratories / M/s Claris Injectable, Vial M/s Reliance Life Sciences Pvt Note: (a) The manufacturer of above mentioned formulations i.e. new drug under paragraph 2(u) of the DPCO, 203 shall fix the retail price as specified in column (6) of the table hereinabove. (b) The manufacturer may add goods and services tax only if they have paid actually or it is payable to the Government on the retail price mentioned in column (6) of the above said table.

8 (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (6) of the above table as per provisions contained in paragraph of the DPCO, 203. The manufacturer shall issue a price list in Form V from date of Notification as per paragraph 24 of the DPCO, 203 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers. (d) As per para 24(4) of DPCO 203, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same. (e) The above mentioned retail price is applicable only to the individual manufacturer / marketeer as mentioned above i.e. who have applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 203 and subject to fulfilment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturer/marketing companies. (f) The concerned manufacturer of above said formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of product in Form-III of Schedule-II of the DPCO, 203 through IPDMS. Manufacturer, in case intending to discontinue above said formulations, shall furnish information to the NPPA, in respect of discontinuation of the production and / or import of above said formulation in Form-IV of Schedule-II of the DPCO, 203 at least six months prior to the intended date of discontinuation. (g) In case the retail price of any of the aforesaid formulations is not complied with, as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 203 read with the Essential Commodities Act, 955. (h) Consequent to the issue of ceiling price of such formulation as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior tothe above said date of notification, stand(s) superseded PN/83/5/207/F F. No. 8(5)/207/D.P./NPPA-Div.-II (BALJIT SINGH) Assistant Director

ORDER. Table. (1) (2) (3) (4) (5) (6) 1. Glimepiride Metformin Tablet

ORDER. Table. (1) (2) (3) (4) (5) (6) 1. Glimepiride Metformin Tablet (Published in Part II, Section 3, Sub-section (ii) of the Gazette of India, Extraordinary) Government of India Ministry of Chemicals and Fertilizers Department of National Pharmaceutical Pricing Authority