Granules India Secures USFDA Approval for ADHD Drugs; How Big Is the Market Opportunity?

Synopsis: Granules India limited’s wholly owned subsidiary company Granules Pharmaceuticals has received Tentative Approval (TA) from U.S. Food and Drug Administration (US FDA) for manufacturing process, quality standard and safety data for its  Abbreviated New Drug Application to treat ADHD.

The shares of this health care company which is one of leading manufacturers of off-patent drugs segment, along with ensuring strong presence in the first line of products such as Paracetamol, Ibuprofen, Metformin and Guaifenesin, were in focus after getting approval from the U.S FDA for one of its drug.

With the market capitalization of Rs. 14,178 Crores, the shares of Granules India limited is trading at around Rs. 584 per share which is 6 percent discount  from its 52 weeks high of Rs. 621 per share  and is trading at a P/E of 27.8 where as sectoral P/E stands at 30.7 

What is the NEWS: 

Granules India Limited’s wholly owned subsidiary company Granules Pharmaceuticals has received Tentative Approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating  Tablets(ADZENYS XR-ODT).

The approved product is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) where the drug has been approved in multiple strengths of  3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg, allowing flexible dosing depending on the patient. The estimated market size for this drug in the US is approximately USD 172 million.

The drug will be manufactured at Granules US-based facility in Chantilly, Virginia making it affordable across the global markets. The market currently has only one approved generic and one authorised generic, which improves revenue potential and margins while strengthening Granules’ presence in ADHD generics in the US. 

About the company and financials: 

Granules India Limited is a vertically integrated pharmaceutical company with presence across the entire value chain, including APIs, PFIs, Finished Dosages, and Peptides CDMO.The company serves 300+ customers across 80+ countries and operates 11 manufacturing facilities across India, the US, and Switzerland. Granules holds multiple global regulatory approvals including US FDA, EU GMP, WHO GMP, EDQM, TGA, and KFDA, supporting its strong presence in regulated markets.

Year on Year analysis: Its revenue from operations has increased from Rs. 967 Crores to Rs. 1297 Crores, up 34 percent. Operating profit has increased from Rs. 203 Crores to Rs. 278 Crores, up 37  percent and net profit has increased from Rs. 97 Crores to Rs. 131 Crores up, 35 percent 

Quarter on Quarter analysis: Its revenue from operations has increased from Rs. 1210 Crores to Rs. 1297 Crores, up 7.2 percent. Operating profit has increased from Rs. 247 Crores to Rs. 278 Crores, up 12.5  percent and net profit has increased from Rs. 113 Crores to Rs. 131 Crores up, 16 percent 

Written By Vachan Kadli 

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