Drug Approval | December 20, 2022
USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod
None of the observations are related to data integrity and management believes that they are addressable
None of the observations are related to data integrity and management believes that they are addressable
The product is backed by required scientific proof and comparative bioequivalence studies
The investment will enable the company to enter European markets as well as enhance margins in current markets
The company will set-up a pharmaceuticals formulation manufacturing unit with an investment of Rs. 100 crore in Odisha
The IPO is a complete OFS by existing shareholder Helix Investment Holdings
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad
Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)
The pharma laboratory is fully equipped with all the machinery needed to support formulation development, resolve technical challenges, and provide customer demonstrations
The total quantity traded at NSE stood at 34,653 shares and the total turnover stood at Rs. 117.23 lakh.
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
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