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
The company has successfully developed Methyl salicylate using Flow Chemistry and successfully erected a Flow reactor at Jhagadia plant and expects to start production from Q3 FY23
Pantoprazole Sodium Sesquihydrate are proton pump inhibitors used in drugs to suppress the gastric acid secretion
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