KEY PRODUCTS
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
01 1GOSERELIN ACETATE
01 1Switzerland
01 1Active
01 1Complete
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2020-03-12
Pay. Date : 2019-11-29
DMF Number : 34363
Submission : 2019-12-19
Status : Active
Type : II
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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 GOSERELIN ACETATE, with a corresponding US DMF Number 34363.
Remarkably, this DMF maintains an Active status since its submission on December 19, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 12, 2020, and payment made on November 29, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
