Granules India gains on nod from Japanese, Brazilian drug regulators

The pharmaceutical raw-materials manufacturer has received approvals from the foreign drug regulators for its Jeedimetla and Bonthapally manufacturing facilities in Telangana

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Granules India shares were up by a percent in the morning trade on August 25 after the pharma company announced receiving an accreditation certificate from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan and compliance approval from ANVISA, the Brazilian health regulator.

The accreditation certificate, which is required by foreign drug manufacturers to export drugs to Japan, was awarded for the company’s Jeedimetla facility in Telangana.

“The certification has been received for accreditation categories of non-sterile drugs, packaging, labelling and storage of drugs,” the company said.

The company received approval from the Brazilian regulator for compliance with the guidelines of good manufacturing practices for its Bonthapally facility in Telangana. The plant makes active pharmaceutical ingredients (APIs).

At 9.30 am, Granules India stock was trading at Rs 298.55 on the National Stock Exchange, up 1.27 percent from the previous close.

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In Q1FY24, the company reported a 3.3 percent year-on- year (YoY) decline in revenue at Rs 985.5 crore. Net profit dropped 62.4 percent YoY to Rs 47.9 crore. Earnings before interest, taxes, depreciation and ammortisation (EBITDA) were down 35.3 percent at Rs 136.8 crore. The EBITDA margin took a hit as well, contracting 680 basis points to 13.9 percent.

The company’s performance was affected due to a cyber security breach apart from supply-chain issues and delay in clearances.

Granules India is engaged in the production of pharmaceutical raw materials. The company specialises in active pharma ingredients, pharmaceutical formulation intermediates as well as finished dosages.

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