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Granules India Shares Rise on Approval from Japanese, Brazilian Drug Regulators

After conducting the inspection, the USFDA issued a Form 483 with six observations.

Shares of Granules India were bullish during the early morning intraday session of 25 August after the company announced that it had received an accreditation certificate from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and compliance approval from ANVISA, the Brazilian health regulator.

The company’s Jeedimetla facility in Telangana was awarded the accreditation certificate that is required to export drugs to Japan.

The company said in its regulatory filing that the certificate had been received for accreditation categories of non-sterile drugs, labelling, packaging, and storage of drugs.

The company’s Bonthapally facility in Telangana has received approval from the Brazilian regulator ANVISA for compliance with the guidelines of good manufacturing practices.

The company’s Bonthapally facility in Telangana makes active pharmaceutical ingredients (API).

Granules India is engaged in the production of pharmaceutical raw materials and specialises in API, pharmaceutical formulation intermediates as well as finished dosage.

Looking at the company’s quarterly numbers for the April-June quarter, the company reported a 3.3% YoY decline in its revenue from operation at Rs 985.5 crore and a 62.4% YoY drop in net profit at Rs 47.9 crore for the quarter under review.

The quarterly performance was affected due to a cyber security breach apart from the supply chain issue and delay in clearance the company was facing during the quarter.

At 10:25 am, the shares of Granules India were trading at Rs 297.15 or 0.80% above its previous close on NSE.

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