KEY PRODUCTS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
01 1NIZATIDINE USP
01 1India
01 1Active
01 1Complete
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-04
Pay. Date : 2013-08-23
DMF Number : 14036
Submission : 1999-03-16
Status : Active
Type : II
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 NIZATIDINE USP, with a corresponding US DMF Number 14036.
Remarkably, this DMF maintains an Active status since its submission on March 16, 1999, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 04, 2013, and payment made on August 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
