KEY PRODUCTS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
01 1LENVATINIB MESYLATE (MIBK SOLVATE)
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 : 2018-10-24
Pay. Date : 2018-08-09
DMF Number : 32905
Submission : 2018-06-26
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 LENVATINIB MESYLATE (MIBK SOLVATE), with a corresponding US DMF Number 32905.
Remarkably, this DMF maintains an Active status since its submission on June 26, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 24, 2018, and payment made on August 09, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
