Granules India Ltd Share Price – NSE  / BSE

Pharmaceuticals, Small Cap

This US drug regulator conducted an inspection from 8 April to 12 April 2024. Now, the inspection is classified as ‘No Action Indicated’ (NAI), indicating compliance with current Good Manufacturing Practices (cGMP) standards and confirming that no further regulatory action is required.

“This outcome reflects the facility's high standards in the production of Active Pharmaceutical Ingredients (APIs) and Finished Dosages (FDs) for both oncology and non-oncology therapeutic areas,” said the drug regulator.

During the inspection, the FDA conducted a comprehensive pre-approval inspection (PAI) and cGMP audit, which concluded with zero Form 483 observations.

Krishna Prasad Chigurupati, chairman & managing director of Granules India said, The successful completion of this US FDA inspection with zero observations and the subsequent receipt of the EIR with NAI status reflects our unwavering commitment to maintaining the highest quality standards in our manufacturing operations.

Granules India is primarily involved in the manufacturing and selling of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation intermediates (PFIs) and Finished Dosages (FDs).

Granules India consolidated net profit fell 4.79% to Rs 97.23 crore on 18.74% declined in total revenue from operations to Rs 966.62 crore in Q2 FY25 over Q2 FY24.

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Profit before tax slipped 5.62% to Rs 128.38 crore in September 2024 quarter as against 136.02 crore recorded in Q2 FY24.

During the quarter, EBITDA declined 4.55% to Rs 203.3 crore as against Rs 213 crore posted in same quarter last year. EBITDA margin improved to 21% in Q2 FY25 as against 18% in Q2 FY24.

Revenue share from the North America grew by 79% in Q2 FY25 as compared to 67% in Q2 FY24.

Finished dosages (FD), Active Pharmaceuticals Ingredients (API) and Pharmaceutical Formulation Intermediates (PFI) contributed 77%, 15%, and 8% of revenue from operations respectively for Q2FY25.

Return on capital employed (ROCE) stood at 16.9% in second quarter of FY24 as compared to 12.9% reported in Q2 FY24.

During the quarter, net debt was at Rs 797.3 crore and Net debt to EBITDA come in at 0.86x.

Krishna Prasad Chigurupati, chairman & managing director of Granules India said, “Q2 sales were impacted by a voluntary pause in manufacturing and distribution from our Gagillapur facility. We delivered strong margins, supported by profitable formulations sales and a favourable product mix. Our operations also generated a healthy cash from operations of Rs 2,007 million”

Granules India is primarily involved in the manufacturing and selling of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation intermediates (PFIs) and Finished Dosages (FDs).

Shares of Granules India gained 4.97% to Rs 578 on the BSE.

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Net profit of Granules India declined 4.79% to Rs 97.23 crore in the quarter ended September 2024 as against Rs 102.12 crore during the previous quarter ended September 2023. Sales declined 19.48% to Rs 956.52 crore in the quarter ended September 2024 as against Rs 1188.00 crore during the previous quarter ended September 2023.

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Bupropion hydrochloride extended-release tablets USP (SR) is bioequivalent and therapeutically equivalent to wellbutrin SR sustained-release tablets, 100 mg, 150 mg, and 200 mg, by GlaxoSmithKline LLC.

The approved ANDA is a widely prescribed medication for the treatment of major depressive disorder and for the prevention of seasonal affective disorder.

The group now has a total of 67 ANDA approvals from the US FDA.

Dr. Krishna Prasad Chigurupati, chairman and managing director, Granules India, said, This ANDA approval marks a significant milestone in our journey to expand Granules’ presence in the U.S. market. Our continued focus on expanding our product portfolio in regulated markets like the U.S. ensures that we are meeting the growing healthcare needs of patients globally, while maintaining the highest standards of safety and efficacy.”

Granules India is primarily involved in the manufacturing and selling of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation intermediates (PFIs) and Finished Dosages (FDs).

The pharma company reported a consolidated net profit of Rs 134.65 crore in Q1 FY25, steeply higher than Rs 47.89 crore posted in Q1 FY24. Revenue from operations in first quarter of FY25 was at Rs 1,179.87 crore, up 19.72% from Rs 985.52 crore reported in the same period a year ago.

Shares of Granules India shed 0.19% to Rs 592.15 on the BSE.

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