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01 1Dr. Reddy's Laboratories

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

GDUFA

DMF Review : Complete

Rev. Date : 2024-03-19

Pay. Date : 2024-02-28

DMF Number : 18348

Submission : 2005-05-13

Status : Active

Type : II

Dr Reddy Company Banner

Looking for Drug Master Files (DMF) for 18348 of Dr Reddys Laboratories Ltd

Looking for Drug Master Files (DMF) for 18348 of Dr Reddys Laboratories Ltd 1

20

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 METOPROLOL SUCCINATE USP, with a corresponding US DMF Number 18348.

Remarkably, this DMF maintains an Active status since its submission on May 13, 2005, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 19, 2024, and payment made on February 28, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II