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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 : 2020-04-03

Pay. Date : 2019-02-01

DMF Number : 33336

Submission : 2019-02-08

Status : Active

Type : II

Bachem company banner

Looking for Drug Master Files (DMF) for 33336 of Bachem Americas Inc

Looking for Drug Master Files (DMF) for 33336 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 LANREOTIDE ACETATE, with a corresponding US DMF Number 33336.

Remarkably, this DMF maintains an Active status since its submission on February 08, 2019, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 03, 2020, and payment made on February 01, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II