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List of Drug Master Files (DMF) for 7686 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Seqens (1)

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01 KETAMINE HYDROCHLORIDE (1)

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01 France (1)

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Looking for Drug Master Files (DMF) for 7686 of Cu Chemie Uetikon Gmbh

Looking for Drug Master Files (DMF) for 7686 of Cu Chemie Uetikon Gmbh 1

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Cu Chemie Uetikon Gmbh, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

One of their notable products is KETAMINE HYDROCHLORIDE, with a corresponding US DMF Number 7686.

Remarkably, this DMF maintains an Active status since its submission on September 22, 1988, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 05, 2019, and payment made on October 28, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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