Europe/India/Near East USA Asia
Bachem AG Bachem Americas, Inc. Bachem Japan K.K.
Hauptstrasse 144 3132 Kashiwa Street AREA Shinagawa, 13F
4416 Bubendorf - Switzerland Torrance, CA 90505 - USA Tokyo 108-0075 - Japan
Tel +41 58 595 2021 Tel +1 888 422 2436 Tel +81 3 4405 3141
Fax +41 58 595 2040 Tel +1 888 4BACHEM Email sales.jp@bachem.com
Email sales.ch@bachem.com Fax +1 310 539 9428  
  E-mail sales.us@bachem.com  

DRUG MASTER FILES (DMF)

Drug Master Files (DMF)

An appropriate Chemistry, Manufacturing and Control (CMC) regulatory document such as a Drug Master File (DMF) or Active Substance Master File (ASMF) that is available by Bachem contains the relevant details of the manufacturing process for an Active Pharmaceutical Ingredient (API) enabling competent authorities (e.g. FDA, EMA) to review process information in support of third party drug product marketing applications. Bachem will provide a letter of authorization/access that will allow the relevant authorities to review the DMF. In addition to submitting regulatory documents in the United States and Europe, Bachem has broad experience filing regulatory documents throughout the world.

 

Bachem has available a DMF for the following generic active pharmaceutical ingredients:


Antazoline Hydrochloride
Antazoline Phosphate
Antazoline Sulfate

Atosiban

Bivalirudin

Buserelin
 
Calcitonin (salmon)
Carbidopa

Deslorelin High Acetate
Desmopressin Acetate
 
Etomidate
 
Glucagon
Gonadorelin Acetate
Goserelin Acetate

Leuprolide Acetate
 
Octreotide Acetate
L-Ornithine ╬▒-Ketoglutarate Monohydrate
 
Propofol
pTH (1-34) (human) Acetate
 
Somatostatin
 
Tetracosactide
Triptorelin Acetate
Triptorelin Pamoate