Drug Master File

for Collagenase NB 6 GMP Grade

Collagenase NB 6 GMP Grade is optimized for isolation of cells designated for transplantation into humans

NEED FDA APPROVAL DRUG MASTER FILE

Registering a New Drug Application? Applying for Export?

Drug Master File for Collagenase NB 6 GMP Grade

• Allows for a smoother and hassle-free registration process with the FDA
• Faster registration
• Less paperwork for applicants

According to the guidelines provided by the FDA, the Drug Master File (DMF)
allows authorities to obtain necessary information to support

• Investigational New Drug Application (IND)
• New Drug Application (NDA)
• Abbreviated New Drug Application (ANDA)
• Another DMF
• Export Application
• Amendments/Supplements to any of these applications

GMP Collagenase with DMFs

• Enzymes currently available with DMF submission
  17458.03 Collagenase NB 6 GMP Grade
  17452.01 Collagenase NB 1 GMP Grade
  30303.01 Collagenase Neutral Protease GMP
• Collagenases* are available in the United States through Crescent Chemical Company.
• Collagenase NB 6 GMP is produced by Nordmark, the world’s largest and leading manufacturer of Collagenase.

• Crescent Chemical Co., Inc. is a WBENC certified small, woman-owned business.
• We can help satisfy your supplier diversity requirements.
• We have been serving the scientific community for over 70 years and pride ourselves on personal attention, technical support, prompt shipping and highly competitive pricing.
• We are the US Distributor for Nordmark Biochemical.

Nordmark is a certified ISO 9001 supplier of biochemicals. All Nordmark biochemical products are subject to stringent quality control to meet the specifications stated in the Certificate of Analysis provided with each product.

⃰ For cell isolation only. Not intended for topical applications.

Crescent Chemical Company, Inc. | 631-348-0333 | www.crescentchemical.com