Bajaj Healthcare’s shares surged over 8% in early trade on September 14, following the receipt of an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Savli plant in Gujarat’s Vadodara.
The USFDA conducted a pre-approval inspection (PAI) at the plant in November 2022, during which no 483 observations were issued. Bajaj Healthcare’s Savli plant is primarily involved in manufacturing Active Pharmaceutical Ingredients (API).
The issuance of the EIR signals the successful conclusion of the inspection and paves the way for filing the company’s Drug Master Files with the USFDA, as well as potential Contract Development and Manufacturing Organization (CDMO) opportunities with global customers.
Anil Jain, Joint Managing Director of Bajaj Healthcare, highlighted these opportunities in a press statement. In the June quarter of the current fiscal year, Bajaj Healthcare reported a net profit of Rs 7.03 crore, representing a 51% decrease compared to the Rs 14.35 crore recorded in the same period of FY23.
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