News | December 19, 2022
Shilpa Medicare introduces cancer drug Capecitabine 1000 MG dispersible tablet
The product is backed by required scientific proof and comparative bioequivalence studies
The product is backed by required scientific proof and comparative bioequivalence studies
The yoga protocol included gentle and restorative yoga postures(asana) with regular periods of relaxation and pranayama
GMP-compliant documentation of all manufacturing steps for cell and gene therapies
Soluplus branded excipient play a critical role in enabling the drug development process for poorly soluble active pharmaceutical ingredients
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
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.
The CRL did not identify any outstanding scientific issues with the product.
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
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