Active Pharmaceutical Ingrediants - Drug Master Files

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Drug Master Files

Morepen has the strategic and technical expertise in documentation related to batch production, quality and regulatory documents. The company has filed the registration documents to various regulatory agencies like USFDA, HPB Canada, EDQM etc. The regulatory documents include DMF, CEP, Technical Package and Registration Dossiers. All these documents are strictly prepared and submitted as per CTD & e-CTD formats & the latest guidelines of health authorities of relevant country. Whereas all the quality related documents are prepared according to cGMP guidelines.


List of DMF

S. No. Product Status
1 Loratadine USDMF, EDMF, Canadian DMF
2 Loratadine HF/ BF3 ( Process -2) USDMF, COS
3 Desloratadine USDMF, EDMF
4 Atorvastatin Calcium Amorphous USDMF, EDMF
5 Atorvastatin Calcium Crystalline, Form VI USDMF, EDMF
6 Atorvastatin Calcium Crystalline,Trihydrate (USP/EP) USDMF, COS Ready
7 Montelukast Sodium USDMF & COS
8 Fexofenadine Hydrochloride EDMF
9 Aliskiren Hemifumarate Technical Package
10 Rosuvastatin Calcium Crystalline Technical Package
11 Rosuvastatin Calcium Amorphous Technical Package