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01 1Bachem AG

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

GDUFA

DMF Review : Complete

Rev. Date : 2015-03-27

Pay. Date : 2015-03-18

DMF Number : 6504

Submission : 1986-07-29

Status : Active

Type : II

Bachem company banner

Looking for Drug Master Files (DMF) for 6504 of Bachem Americas Inc

Looking for Drug Master Files (DMF) for 6504 of Bachem Americas Inc 1

20

Bachem Americas Inc, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

One of their notable products is SALMON CALCITONIN (SCT), with a corresponding US DMF Number 6504.

Remarkably, this DMF maintains an Active status since its submission on July 29, 1986, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 27, 2015, and payment made on March 18, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II