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List of Drug Master Files (DMF) for 7033 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Dr. Reddy's Laboratories (1)

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01 BENZTROPINE MESYLATE USP (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

Looking for Drug Master Files (DMF) for 7033 of Dr Reddys Laboratories Ltd

Looking for Drug Master Files (DMF) for 7033 of Dr Reddys Laboratories Ltd 1

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Dr Reddys Laboratories Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

One of their notable products is BENZTROPINE MESYLATE USP, with a corresponding US DMF Number 7033.

Remarkably, this DMF maintains an Active status since its submission on June 18, 1987, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 02, 2021, and payment made on March 30, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II

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