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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 : 2016-10-07

Pay. Date : 2016-05-11

DMF Number : 30467

Submission : 2016-06-29

Status : Active

Type : II

Bachem company banner

Looking for Drug Master Files (DMF) for 30467 of Bachem Ag

Looking for Drug Master Files (DMF) for 30467 of Bachem Ag 1

20

Bachem Ag, 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 LIRAGLUTIDE DRUG SUBSTANCE, with a corresponding US DMF Number 30467.

Remarkably, this DMF maintains an Active status since its submission on June 29, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 07, 2016, and payment made on May 11, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II