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BUSINESS

Alembic Pharma Clears Brazilian Health Regulator Audit

The GMP assessment by the Brazilian Health Regulatory Agency (ANVISA) took place between 16 - 20 September.

Alembic Pharma Ltd on Wednesday, 11 December, announced that it had successfully completed the API-II facility audit at Panelav for eight active pharmaceutical ingredients (APIs) conducted by the Brazilian health regulator.

According to the business, the GMP (Good Manufacturing Practices) assessment by the Brazilian Health Regulatory Agency (ANVISA) took place between 16 September and 20 September 2024.

Improved execution skills within India’s branded business, especially in the speciality and animal health areas, were credited with their impressive success. The USFDA conducted an inspection of the company’s Oncology Formulation Facility (F-2) during the reviewed quarter, and no Form 483 observations were found.

The India Branded Business increased by 6% during the quarter, reaching Rs 609 crore. The company’s speciality medicines saw robust growth, with gynaecology seeing an 8% increase, cardiology seeing 11%, anti-diabetic seeing 18%, and ophthalmology seeing 13%. Due to a solid portfolio of products, the animal health segment saw a 20% increase. Alembic also introduced three new items during the quarter.

In the global business, the US Generics division launched eight new products in the US market, which increased by 5%, generating Rs 467 crore. The value of Ex-US International Formulations increased by 18% to Rs 298 crore. Nine ANDA approvals were granted to Alembic during the quarter, increasing the total to 214.

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