KEY PRODUCTS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
01 1LEVOFLOXACIN HEMIHYDRATE 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 : 2020-08-14
Pay. Date : 2020-08-10
DMF Number : 16658
Submission : 2003-06-24
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 LEVOFLOXACIN HEMIHYDRATE USP, with a corresponding US DMF Number 16658.
Remarkably, this DMF maintains an Active status since its submission on June 24, 2003, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 14, 2020, and payment made on August 10, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
