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List of Drug Master Files (DMF) for 9231 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 CARBIDOPA (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 9231 of Bachem Sa

Looking for Drug Master Files (DMF) for 9231 of Bachem Sa 1

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Bachem Sa, 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 CARBIDOPA, with a corresponding US DMF Number 9231.

Remarkably, this DMF maintains an Active status since its submission on July 11, 1991, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 11, 2013, and payment made on June 17, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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