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May 2017 Pharmadocx LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 1 NEW DRUG LIST 1961- 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-131001 Ph. 0130-2200630, (M) +91-9896133556, E-mail : [email protected], Web : www.pharmadocx.com Blog: http://pharmadocx.wordpress.com, Skype : Yashdeep Pharmaceuticals PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com 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 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com 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 Co- pack 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, 1977 2-Bromo-2-nitropropan-1,3-diol Sep,1972 2-Pyrrolidone Acetamide Dec,1977 2-Pyrrolidone Acetamide Capsule 400 mg Jan,1978 2-Pyrrolidone Acetamide Injection 200mg/ml Jan,1978 2-thymyl-oxy-methyl glyoxalidine hydrochloride Nasal Spray Jan,1971 3 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,1972 40mg 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,1977 5-Fluorouracil Oral Solution 250mg/5ml Jan,1979 5-Methylsulphadiazine 02.05.1997 6 aminopenicillanic acid Capsule, 250 & 500 mg May,1974 6 aminopenicillanic acid Injection 250 & 500 mg Aug,1979 6 aminopenicillanic acid Oral Suspension 125mg/5ml, 250mg/5ml Aug,1979 7 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 22.03.2002 Abacavir Sulfate Tablet 60mg 1.08.2009 Abacavir Sulphate syrup 20mg/ml 29/08/06 Abatacept powder for injection 250mg/vial 22.07.08 Abatacept Injection 250mg/vial (Addl. Indication) 20.02.09 Abatacept Injection 250mg/vial (additional indication) 10.04.09 Abciximab 21.03.1996 Abiraterone acetate Tablet 250 mg (Additional Indication) 27.3.15 Abiraterone Acetate Tablet 250 mg (Additional Indication) 12.08.2016 Abiraterone Acetate Tablets 250mg 16.12.11 Acamprosate Calcium 30.10.2002 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 4 Acarbose 06.03.1997 Acarbose 25mg/50mg + Metformin 500mg/500mg FC Tablet 23.02.2009 Acarbose tabs 50mg/100mg 6-Mar-97 Acebrophylline capsules 100mg 29.05.08 Acebrophylline SR Tablet 200 mg 23.11.10 Acebrophylline Syrup 10mg/ ml 09.01.09 Acebrophylline Syrup 10mg/ml (Additional Indication) 30.03.09 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 15-09-2003 Aceclofenac gel 1.5% alongwith linseed oil, menthol, Salicylate, Capsaicin 06/08/2005 gel Aceclofenac (100 mg) + Paracetamol (500 mg) 29-06-2004 Aceclofenac 1% w/w + Menthol 5% Spray 28/05/2010 Aceclofenac 100mg + Tizanidine 2mg film coated tablets 23.02.09 Aceclofenac 100mg + Paracetamol 500mg tablets 08.07.2004 Aceclofenac 200mg (S.R) tablet 22/02/2006 Aceclofenac 200mg / 200mg SR + Rabeprazole 10mg / 20mg Capsule 01.07.2009 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) 19.02.07 Aceclofenac injection 150mg/ml 23.01.08 Aceclofenac IP (Sustained released pellets) 200mg/200mg + 04.01.12 Thiocolchicoside IP (Sustained released pellets) 8mg/16mg Capsules. (New Dosage Form) Aceclofenac Roll - On 1% 24.10.08 Aceclofenac 100mg + Tizanidine 2mg film coated tablets 23.02.09 Aceclofenac (100mg) + Thiocolchicoside (4 mg) tablets (Additional 11.08.2009 strength) Aceclofenac (100mg) + Thiocolchicoside (8 mg) tablets 3.08.2009 Acesulfame Potassium 05.04.2005 Acetyl Cysteine Eye Drops 5% w/v 14.12.2010 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. 26.11.2009 Acitretin 9/9/2005 Aclarubicin HCl Mar-88 Aclarubicin Inj. Mar-88 Acotiamide Hydrochloride Bulk & Tablet 100mg 06.07.2016 Acrivastine Capsules 8mg 26.09.11 Actarit 100mg Tablets 22.07.08 Activated Dimethicone 50mg + Magnesium Hydroxide 250mg+ Dried 28/05/2010 Aluminium Hydroxide250 mg + Sorbitol (70%)1.25 gm /5ml Solution PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com 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 30.08.11 Acyclovir SR Tablet 1200 mg 11.09.10 Acyclovir Tablets/ Cream/ Ointment/ Ophthalmic Ointment May-87 Adapalene 0.1% + Benzoyl Peroxide 2.5% gel 24.10.08 Adapalene1mg +Clindamycin Phosphate eq. to Clindamycin 10mg per gram 01.05.2003 Gel Adefovir Dipivoxil 4/3/2004 Ademetionine enteric coated Tablets 200mg/400mg 01.09.10 Adenosine 09.07.1997 Adenosine injection 6 mg /2ml 8-Jul-97 Adenosylcobalamin 15mcg + Ferrous Ascorbate 100mg + Folic Acid IP 21.03.11 1.5mg + Zinc Sulphate USP Eq. to Elemental Zinc 22.5mg tablet Afatinib Tablets 20mg/30mg/40mg/50mg (Free base) corresponding to 27.09.2016 Afatinib dimaleate 29.56mg/44.34mg/59.12mg/73.9mg (Additional Indication) Agomelatine Tablets 25mg 10.09.2012 Akiskiren Hemifumarate eq. to Aliskiren 12.10.11 150mg/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 25.04.2009 Albendazole Suspension 2.5 % w/v & 10% w/v Oct, 1979 Albendazolesuspension200mg/5ml 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 25.04.2009 Alcaftadine Eye Drops 0.25% w/v & Bulk 21.11.2016 Alclometasone Dipropionate 1985 to 87 Alclometasone Dipropionate cream/ointment 0.05% Jul-87 Alendronate 70mg + Colealciferol 140mcg (5600 IU) Tablets 10.11.2009 Alendronate Sodium 18-Sep-97 Alendronate Sodium (equiv. to Alendronic acid 70mg) + Cholecalciferol 02/01/2006 70mcg (equiv. to 2800 I.U Vit.D) Tablet Alendronate Sodium tab -10mg 18-Sep-97 Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg tablet 14.06.07 Aliskiren 150/150/300/300mg + HCTZ 12.5/25/12.5/25mg tablets 08.05.08 Aliskiren 150/160mg +
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