Drug Approval | November 09, 2022
Lupin receives tentative approval from USFDA for Doxycycline Capsules
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
The acquisition is for an enterprise value of Rs. 218 crores
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
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
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
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