Regulatory Services
Regulatory Documentation
Successful Cases
- EDMF (European Drug Master File)
- DMF (Drug Master File)
- COS/CEP(Certificate of Suitability for European Pharmacopoeia)
- Other Documentation – SMF/PMF
EDMF (European Drug Master File):Top
Prepared European Drug Master File (EDMF) for following products:
| 01 | Sulfadimidine | 02 | Rifampicin 30 |
| 03 | L-lysine acetylsalicylate | 04 | Sulfathiazole |
| 05 | Sulfabenzamide | 06 | Penicillin G Potassium |
| 07 | Natamycin | 08 | Ticlopidine Hydrochloride |
| 09 | Oxytetracycline dihydrate | 10 | Oxytetracycline Hydrochloride |
| 11 | Streptomycin sulfate | 12 | Streptomycin Sulphate |
| 13 | Ciprofloxacin Hydrochloride | 14 | Simvastatin |
| 15 | Isotretinoin | 16 | Tretinoin |
| 17 | Colistin Sulphate | 18 | Mirtazapine |
| 19 | Isoniazid | 20 | Torasemide |
| 21 | Citicoline sodium | 22 | Roxithromycin |
| 23 | Ephedrine hydrochloride | 24 | Pseudoephedrine hydrochloride |
| 25 | Doxycycline | 26 | Benzylpenicillin |
| 27 | Vitamin C (Ascorbic Acid) | 28 | Thioctic Acid |
| 29 | Red Clover Extract | 30 | Gentamycin sulfate |
| 31 | Tetracycline Hydrochloride | 32 | Metronidazole |
| 33 | Carbidopa | 34 | Tylosin Tartrate |
| 35 | Rifamycin SV Na | 36 | Acitretin |
| 37 | Ammonium glycyrrhizinate | 38 | Benzylpenicillin |
| 39 | Etodolac | 40 | Folic acid |
| 41 | Glucose anhydrous | 42 | Metamizole Sodium |
| 43 | Paracetamol | 44 | Paracetamol DC90 |
| 45 | Rifamycin-S | 46 | Tranexamic Acid |
| 47 | Gliclazide | 48 | Pacilitaxel |
| 49 | Sotalol hydrochloride | 50 | Sulfacetamide |
| 51 | Trithioanethole | 52 | 7-ACA |
| 53 | Ivermectin | 54 | Avermectin |
| 55 | GCLE | 56 | Cefdinir |
DMF (Drug Master File):Top
| 7-Aminocephalosporanic Acid | DMF Number | 16105 and 16299 |
| Penicillin G Potassium | DMF Number | 16106 |
| Etodolac | DMF Number | 16789 |
| Folic Acid | DMF Number | 17004 |
| Acetaminophen | DMF Number | 17005 |
| Metamizole Sodium | DMF Number | 17006 |
| Sulfamethazine | DMF Number | 3866 |
| Losartan Potassium | DMF Number | 18780 |
| Gliclazide Ivermectin Avermectin GCLE Spiked Port and Injection port |
DMF Number VMF Number VMF Number DMF Number Type III DMF No. |
19921 005906 005907 21168 21281 |
COS/CEP(Certificate of Suitability for European Pharmacopoeia):Top
- Hunan Dongting Pharmaceutical Co., Ltd.
COS for one product on June 6, 2008: TRANEXAMIC ACID R0-CEP 2006-142-Rev 00 - Zhejiang Zhenyuan Pharmaceutical Co., Ltd.
COS for one product on June 5, 2008: NETIMICIN SULPHATE R0-CEP 2006-036-Rev 00
COS for one product on Sept. 9, 2004: ROXITHROMYCIN R0-CEP2003-008 - Shandong Jinyang Pharmaceutical Co., Ltd.
COS for one product on Nov. 15, 2007 (consulted on GMP inspection by EDQM): OXYTETRACYCLINE R0-CEP 2004-177-Rev 00 - Hebei Shengxue Dacheng Pharmaceutical Co., Ltd.
COS for one product on Sept. 21, 2007 (consulted on GMP inspection by EDQM): OXYTETRACYCLINE R0-CEP 2004-055-Rev 00 - Hebei Jiheng (Group) Pharmaceutical Co., Ltd.
COS for one product on Nov. 08, 2006: PARACETAMOL R0-CEP 2005-032-Rev 00 - Hebei Shengxue Glucose Co., Ltd.
COS for one product on Oct. 02, 2006: GLUCOSE R0-CEP 2004-274-Rev 00 - Zhejiang Liaoyuan Pharmaceutical Co., Ltd.
COS for one product on July 07, 2006 (consulted on GMP inspection by EDQM): TICLOPIDINE HYDROCHLORIDE R0-CEP 2004-109-Rev 00 - Xinjiang Heshuo Ephedrine Product Co., Ltd.
COS for 2 products on Dec. 15, 2005: EPHEDRINE HYDROCHLORIDE R0-CEP2004-152
PSEUDOEPHEDRINE HYDROCHLORIDS R0-CEP2004-153 - Anqiu Luan Pharmaceutical Co., Ltd.
COS for one product on Mar. 22, 2002: PARACETAMOL R0-CEP2000-124
OTHER DOCUMENTATION – SMF/PMF:Top
SMF/PMF (Plant Master File or Site Master File) for some manufacturers, used for registration in India and Brazil.