Active Pharmaceutical Ingrediants

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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 (Process 1)
USDMF, EDMF, Canadian DMF
2.
Loratadine (Process 2)
USDMF, CEP
3.
Desloratadine
USDMF, EDMF, Canadian DMF
4.
Atorvastatin Calcium Amorphous
USDMF, EDMF
5.
Atorvastatin Calcium Crystalline
USDMF, EDMF
6.
PioglitazoneHCl
USDMF, EDMF
7.
Montelukast Sodium
EDMF
8.
FexofenadineHCl
EDMF
9.
Fluvastatin sodium
Canadian DMF
10.
Cisapride
EDMF, Canadian DMF
11.
Linezolid
Technical Package
12.
Paracetamol
Technical Package
13.
Telmisartan
Technical Package