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List of Drug Master Files (DMF) for 9951 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 DESMOPRESSIN ACETATE (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 9951 of Bachem Americas Inc

Looking for Drug Master Files (DMF) for 9951 of Bachem Americas Inc 1

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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 DESMOPRESSIN ACETATE, with a corresponding US DMF Number 9951.

Remarkably, this DMF maintains an Active status since its submission on November 05, 1992, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 31, 2017, and payment made on March 27, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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