Shilpa Medicare Ltd's finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana has received Health Canada GMP approval
This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units
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
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
It will undertake academic and collaborative research activities in Ayurveda, including herbal medicine and yoga, as well as design academic standards, short-term/medium-term courses, and educational guidelines
The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited
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.
Most of the new growth Capex investments are happening on the Specialty Chemicals and Nutrition side
The CRL did not identify any outstanding scientific issues with the product.
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