Cetrorelix DMF Submission Announcement

Amzeal News/10367075
CPC Scientific Inc.
SAN JOSE, Calif. - Amzeal -- CPC Scientific Inc., a San Jose based CDMO with GMP manufacturing facilities in Hangzhou, is pleased to announce that their drug master file (DMF) for cetrorelix acetate has been submitted to the U.S. Food and Drug Administration and has been issued DMF# 034884. This generic peptide API type II DMF includes characterization and manufacturing controls of the intermediates and final peptide API. Cetrorelix is a synthetic decapeptide used to inhibit premature luteinizing hormone surges for assisted reproduction applications (e.g., In vitro fertilization, IVF). The peptide is an antagonist to gonadotropin-releasing hormone (GnRH) in the pituitary gland and suppresses the production of luteinizing hormone (LH) and follicle-stimulating hormone (FSH).

Comment from Shawn Lee, CEO and Founder of CPC Scientific Inc.-

"We are very excited about the addition of the cetrorelix DMF to our growing generic peptide portfolio. Our multi-kg scale cGMP manufacturing facility for cetrorelix will provide more opportunities for IVF treatments in the medical communities and pathways to new treatments for hormone-sensitive breast and prostate cancers."

More on Amzeal News
About CPC Scientific Inc.
Founded in 2001, CPC Scientific is a globally recognized and leading CDMO specializing in synthetic peptide production. The company works directly with leaders in the biotechnology and pharmaceutical industries to help bring life-changing therapeutics and diagnostics to market. They boast the largest research peptide facility in the world, which successfully has undergone multiple FDA inspections and audits by global pharma organizations. CPC Scientific has the capability of serving customers from early drug discovery stages through clinical trials to commercial manufacturing. We provide milligram to multi-kilogram quantities of CGMP and research-grade peptides with purities of up to 99%. With their emphasis on technology, innovation, and experience, we are proud to have a US FDA inspected GMP facility, ISO 9001, and ISO 13485 certification, a claim few companies in the world can make.

Inquiries:
CPC Scientific Inc.
Dr. Chris Gothard +1-408-734-3800 (San Jose, CA)
EMAIL: chris@cpcscientifc.com

Website press release
Generics DMF schedule
CPC Scientific website

Contact
Chris Gothard
***@cpcscientific.com


Source: CPC Scientific
stats
Show All News | Report Violation

0 Comments
1000 characters max.

Latest on Amzeal News