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List of Drug Master Files (DMF) for 29805 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Alchem International Private Ltd (1)

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01 METHSCOPOLAMINE BROMIDE USP (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

29805
Active
2015-09-24
Complete
2015-11-20
2015-09-28
II
Alchem

Biotechgate Digital

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Looking for Drug Master Files (DMF) for 29805 of Alchem International Private Ltd

Looking for Drug Master Files (DMF) for 29805 of Alchem International Private Ltd 1

20

Alchem International Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

One of their notable products is METHSCOPOLAMINE BROMIDE USP, with a corresponding US DMF Number 29805.

Remarkably, this DMF maintains an Active status since its submission on September 24, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 20, 2015, and payment made on September 28, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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