KEY PRODUCTS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
01 1ELAGOLIX SODIUM
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 : 2022-01-26
Pay. Date : 2021-12-17
DMF Number : 35473
Submission : 2021-01-22
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 ELAGOLIX SODIUM, with a corresponding US DMF Number 35473.
Remarkably, this DMF maintains an Active status since its submission on January 22, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 26, 2022, and payment made on December 17, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
