Drug Approval | December 01, 2022
JB Pharma gets USFDA approval for its generic Venlafaxine Extended-Release Tablets
This product is based on Osmotic Controlled Release Oral Delivery System technology
This product is based on Osmotic Controlled Release Oral Delivery System technology
40,000 visitors and representatives of more than 80 countries set to visit the show
The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site
Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)
The company sees the business reaching $100mn
Formulation revenue decreased by 7.6% YoY to Rs. 4,770 crore whereas in Q2 FY23, API business posted a growth of 24.2% YoY with revenue of Rs. 969.4 crore
First and only next-generation protein-based adjuvanted COVID-19 booster approved in Europe
The European Commission will review the CHMP recommendation and is expected to make a final decision soon.
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
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