loader
Please Wait
Applying Filters...

Athena Athena

X

List of Drug Master Files (DMF) for 25745 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Virtual Booth
Menu
Filters Filter
Cross PopUp
FILTER :

filter

01 Dr. Reddy's Laboratories (1)

filter

01 ASENAPINE MALEATE (1)

filter

01 India (1)

filter

01 Active (1)

filter

01 Complete (1)

Looking for Drug Master Files (DMF) for 25745 of Dr Reddys Laboratories Ltd

Looking for Drug Master Files (DMF) for 25745 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 ASENAPINE MALEATE, with a corresponding US DMF Number 25745.

Remarkably, this DMF maintains an Active status since its submission on March 26, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 12, 2013, and payment made on April 12, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

Post Enquiry
POST ENQUIRY