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Athena Athena

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List of Drug Master Files (DMF) for 18277 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Bachem AG (1)

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01 GLUCAGON (1)

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01 Switzerland (1)

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01 Active (1)

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01 Complete (1)

Looking for Drug Master Files (DMF) for 18277 of Bachem Ag

Looking for Drug Master Files (DMF) for 18277 of Bachem Ag 1

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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 GLUCAGON, with a corresponding US DMF Number 18277.

Remarkably, this DMF maintains an Active status since its submission on April 12, 2005, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 07, 2015, and payment made on April 27, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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