USFDA completes pre-approval inspection of BHL's Vadodara facility
The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited
The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited
The company sees the business reaching $100mn
Investment in R&D was Rs. 337.6 crore (8.3% of sales) for Q2 FY2023 as compared to Rs. 330 crore (8.2% of sales) for Q2 FY2022.
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.
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