Drug Approval | November 07, 2022
Lupin receives tentative approval from USFDA for Drospirenone Tablets
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
API platform to comprise of RA Chem Pharma, ZCL Chemicals and Avra Laboratories
The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
A well researched and affordable fixed dose combination, which will significantly improve the glycemic control in adult patients suffering from uncontrolled Type 2 diabetes, especially the ones with comorbidities
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of US $112 million in the US
Around 62% of the revenues came from the domestic market and 38% from the exports market for Q2 FY23 for a standalone business
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
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