Europe/India/Near East USA Asia
Bachem AG Bachem Americas, Inc. Bachem Japan K.K.
Hauptstrasse 144 3132 Kashiwa Street Ueno Bldg, 8F
4416 Bubendorf - Switzerland Torrance, CA 90505 - USA 1-9-10 Nihonbashi-Horidome cho, Chuo-ku
Tel +41 58 595 2021 Tel +1 888 422 2436 Tokyo 103-0012 - Japan
Fax +41 58 595 2040 Tel +1 888 4BACHEM Tel +81 3 6661 0774
Email sales.ch@bachem.com Fax +1 310 539 9428 Email sales.jp@bachem.com
  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.

 

Antazoline Hydrochloride

 

Antazoline Phosphate

 

Antazoline Sulfate

 

Atosiban

 

Bivalirudin

 

Buserelin

 

Carbidopa

 

Desmopressin Acetate

 

Etomidate

 

Exenatide Acetate

 

Glucagon

 

Gonadorelin Acetate

 

Goserelin Acetate

 

Icatibant Acetate

 

Lanreotide

 

Leuprolide Acetate

 

Octreotide Acetate

 

Propofol

 

pTH (1-34) (human) Acetate

 

Somatostatin

 

Tetracosactide

 

Triptorelin Acetate

 

Triptorelin Pamoate

 

(Arg8)-Vasopressin