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List of Drug Master Files (DMF) for 28446 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 TICAGRELOR (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 28446 of Dr Reddys Laboratories Ltd

Looking for Drug Master Files (DMF) for 28446 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 TICAGRELOR, with a corresponding US DMF Number 28446.

Remarkably, this DMF maintains an Active status since its submission on August 28, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 27, 2014, and payment made on August 07, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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