KEY PRODUCTS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
01 1GEMCITABINE HYDROCHLORIDE 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 : 2016-06-27
Pay. Date : 2016-06-06
DMF Number : 18857
Submission : 2005-10-11
Status : Active
Type : II
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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 GEMCITABINE HYDROCHLORIDE USP, with a corresponding US DMF Number 18857.
Remarkably, this DMF maintains an Active status since its submission on October 11, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 27, 2016, and payment made on June 06, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
