R Orchid Chemicals & Pharmaceuticals Ltd. Orchid Towers 313, Valluvar Kottam High Road, Nungambakkam, Chennai 600 034, India. Tel : (91) 4428211000 Fax : (91) 4428211002 Email : corporate@orchidpharma.com Website: www.orchidpharma.com
R One of India's leading vertically integrated pharmaceutical companies with credentials in research, manufacturing and marketing of oral and injectable antibiotic APIs and oral generics. Our operations cover the entire pharmaceutical value chain from discovery to delivery Stateoftheart API and formulations manufacturing facilities with approvals from leading global agencies including US FDA, UK MHRA, EDQM, PMDA, DMA, ANVISA, KFDA, TGA, ISO 9001:2008, ISO 14001: 2004, OHSAS 18000: 2007, WHO GMP providing a global competitive edge. Reliable track record of regulatory filings and large product pipeline with total addressable market size of US$6570 billion We possess a footprint across 70 countries through direct presence, alliances and partnerships Our CRAMS value proposition encompasses the value chain bioinformatics to commercial supply in multiple therapeutic areas across all segments of the pharmaceutical value chain.
APIs Specialises in niche APIs for injectables and orals that have limited competition due to high entry barriers (complex chemistry, multistep manufacturing and a challenging patent environment)
Cephalosporins API List Cephalosporins Orals Pharmacopeia US DMF EDMF CoS Cefalexin Cefadroxil Cefradine Cefuroxime Axetil (Amorphous) Cefuroxime Axetil (Crystalline) Cefprozil Cefditoren Pivoxil (Amorphous) Cefditoren Pivoxil (Crystalline) Cefdinir Cefpodoxime Proxetil Ceftibuten Cefcapene Pivoxil Hydrochloride Ceftamet Pivoxil / EP / BP / JP / EP / BP / JP / EP / BP / EP / BP / EP / BP / JP Inhouse / JP / JP / EP / JP Inhouse JP JP Cephalosporins Injectables Pharmacopeia US DMF EDMF CoS Cefotaxime Sodium (Sterile) Ceftriaxone Sodium (Sterile) / EP / BP / JP / EP exploitation, including development, sales and offer for sales are performed where permissible by patent law. US DMF US Drug Master File CoS Certificate of Suitability United States Pharmacopeia JP Japanese Pharmacopeia Technical Information Package EP European Pharmacopeia BP British Pharmacopeia EDMF European Drug Master File
Cephalosporins Injectables Pharmacopeia US DMF EDMF CoS Ceftazidime Pentahydrate with Sodium Carbonate for Injection / EP / BP / JP Cefazolin Sodium (Sterile) Cefoxitin Sodium (Sterile) Cefepime + Arginine (Sterile) Cefpirome Sulphate Cefuroxime Sodium (Sterile) Ceforanide + LLysine Cefalothin Sodium Buffered (Sterile) Ceftizoxime Sodium (Sterile) Cefoperazone Sodium (Sterile) Cefotiam Hexetil Cefotiam Hydrochloride Cefozopran Hydrochloride / EP / BP / JP / EP / BP Inhouse / EP EP JP / EP JP JP JP Veterinary s Pharmacopeia US DMF EDMF CoS Cefalonium Cefquinome Sulphate (Sterile) Ceftiofur Hydrochloride Ceftiofur Sodium (Sterile) BP Inhouse Inhouse exploitation, including development, sales and offer for sales are performed where permissible by patent law. US DMF US Drug Master File CoS Certificate of Suitability United States Pharmacopeia JP Japanese Pharmacopeia Technical Information Package EP European Pharmacopeia BP British Pharmacopeia EDMF European Drug Master File
Non API List Pharmacopeia US DMF EDMF CoS Aripiprazole Eszopiclone Felodipine Gemifloxacin Mesylate Granisetron Hydrochloride Ibandronate Sodium Memantine Hydrochloride Modafinil Naratriptan Hydrochloride Olanzapine Pramipexole Dihydrochloride Quetiapine Fumarate Rasagiline Mesylate Rivastigmine Tartrate Sumatriptan Succinate Tadalafil Terbinafine Hydrochloride Zaleplon EP InHouse / EP / BP InHouse / E P/ BP InHouse InHouse / EP / EP / EP InHouse InHouse US P/ EP / EP / BP EP / EP / BP Non API Pipeline Cinacalcet Lurasidone Silodosin Solifenacin Succinate exploitation, including development, sales and offer for sales are performed where permissible by patent law. US DMF US Drug Master File CoS Certificate of Suitability United States Pharmacopeia JP Japanese Pharmacopeia Technical Information Package EP European Pharmacopeia BP British Pharmacopeia EDMF European Drug Master File
FDFs We stand for niche global leadership in our operating domains. This is reflected in our ability to develop and manufacture products across therapeutic categories. We are respected for our competence in aseptic manufacture, complex chemistry and challenging formulations.
EU CTD Dossiers Available Nons Dosage Form Dosage Strength Therapeutic Area Memantine Rivastigmine Naratriptan Modafinil Aripiprazole Rasagiline 10 mg 1.5, 3, 4.5 & 6 mg 2.5 mg 100 & 200 mg 5, 10, 15 & 30 mg 1 mg Antiparkinsonian Granisetron 1 & 2 mg Gastrointestinal Terbinafine 250 mg Antifungal Terbinafine 250 mg Antifungal Cephalosporins Dosage Form Dosage Strength Therapeutic Area Cefalexin Cefalexin Cefprozil Cefprozil 250 & 500 mg 250mg/5ml 250 & 500 mg 250mg/5ml 200 & 400 mg Dispersible 400 mg 100mg/5ml Cefpodoxime Proxetil 100 & 200 mg Cefuroxime Axetil 125, 250 & 500 mg exploitation, including development, sales and offer for sales are performed where permissible by patent law. OD Orally Disintegrating ER Extended Release DR Delayed Release
EU CTD Dossiers Pipeline Nons Dosage Form Dosage Strength Therapeutic Area Cetirizine Hydrochloride 5 & 10 mg Antiallergics Roflumilast Cinacalcet 0.5 mg 30, 60 & 90 mg Respiratory Calcimimetic Dexlansoprazole Pantoprazole Felodipine DR DR ER 30 & 60 mg 20 & 40 mg 2.5, 5 & 10 mg Gastrointestinal Gastrointestinal Cardiovascular Risedronate Sodium Risedronate Sodium DR 30 & 35 mg 35 mg Osteoporosis Osteoporosis Ibandronate Sodium Silodosin Solifenacin Succinate 150 mg 4 & 8 mg 5 & 10 mg Osteoporosis Urology Urology Fesoterodine Sumatriptan Succinate Zaleplon Zolmitriptan Droxidopa Eszopiclone Pramipexole Dihydrochloride Ropinirole Hydrochloride Lurasidone Olanzapine Olanzapine ER OD 4 & 8 mg 25, 50 & 100 mg 5 & 10 mg 2.5 & 5 mg 100, 200 & 300 mg 1, 2 & 3 mg 0.125, 0.25, 0.5, 0.75, 1 & 1.5 mg 0.25, 0.5, 1, 2, 3, 4 & 5 mg 20, 40, 60, 80 & 120 mg 5, 10, 15 & 20 mg 2.5, 5, 7.5, 10, 15 & 20 mg Urology Parkinsonism Parkinsonism exploitation, including development, sales and offer for sales are performed where permissible by patent law. OD Orally Disintegrating ER Extended Release DR Delayed Release
EU CTD Dossiers Pipeline Nons Dosage Form Dosage Strength Therapeutic Area Vilazodone HCl 10, 20 & 40 mg Quetiapine Fumarate Lacosamide 25, 50, 100, 200, 300 & 400 mg 50, 100, 150, 200 mg Anticonvulsant Eslicarbazepine acetate Miltefosine Gemifloxacin Mesylate Tapentadol Tapentadol ER 200, 400, 600, 800 mg 50 mg 320 mg 50, 75, 100 mg 25, 50, 100, 150, 200, 250 mg Anticonvulsant Antifungal Antibacterial Opiod Analgesic Opiod Analgesic Fingolimod Hydrochloride Rivaroxaban Dabigatran mesylate Varenicline 0.5 mg 2.5, 10, 15, 20 mg 75, 110, 150 mg 0.5, 1 mg Immunomodulator Anticoagulant Anticoagulant Nicotine Addiction Cephalosporins Dosage Form Dosage Strength Therapeutic Area Cefdinir Cefdinir Ceftibuten Ceftibuten Cefuroxime Axetil Chewable 300 mg 125mg/5ml & 250mg/5ml 200 & 400 mg 180mg/5ml 125mg/5ml & 250mg/5ml 100mg, 150mg & 200 mg 400 mg exploitation, including development, sales and offer for sales are performed where permissible by patent law. OD Orally Disintegrating ER Extended Release DR Delayed Release