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List of Drug Master Files (DMF) for 30724 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 DIGOXIN USP (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

30724
Active
2016-07-06
Complete
2017-06-30
2017-05-04
II
Alchem

Biotechgate Digital

Not Confirmed

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Looking for Drug Master Files (DMF) for 30724 of Alchem International Private Ltd

Looking for Drug Master Files (DMF) for 30724 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 DIGOXIN USP, with a corresponding US DMF Number 30724.

Remarkably, this DMF maintains an Active status since its submission on July 06, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 30, 2017, and payment made on May 04, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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