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Granules India Ltd on Thursday said its arm Granules Pharmaceuticals, Inc has received tentative approval from the US health regulator for its generic amphetamine extended-release tablets indicated for treatment of attention deficit hyperactivity disorder, with eligibility of 180-day exclusivity. The tentative approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Amphetamine extended-release tablets in strengths of 5 mg, 10 mg, 15 mg, and 20 mg, Granules India Ltd said in a regulatory filing. These are the generic equivalent of DYANAVEL XR, it added. "The Granules ANDA has been determined to be eligible for 180-day exclusivity by the FDA, reinforcing its growing capabilities in developing and commercialising complex and differentiated generic products for the US market," the company said. The product is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and has an estimated market size of USD 41 ...
Pfizer is suing over some unsolicited competition in its nearly $5 billion bid to buy the drugmaker Metsera. New York-based Pfizer said Friday after markets closed that it was suing Metsera and a third drugmaker, Denmark's Novo Nordisk, over a bid for Metsera that Novo announced Thursday. Novo said it planned to buy Metsera in a deal that could be worth up to $9 billion, and Metsera said the offer appeared to be superior to Pfizer's bid, which was announced in September. Metsera Inc has no products on the market, but it is developing potential oral and injectable treatments. That includes some potential treatments that could target lucrative fields for obesity and diabetes. Novo already has the treatments Wegovy and Ozempic on the market in those respective categories. Pfizer said the offer from Novo cannot be considered superior to its bid because it carries significant regulatory risk that makes it unlikely to be completed. Pfizer, which ended development of a potential pill to
Patel Chem Specialities, a manufacturer of starch-based pharmaceutical excipients, on Thursday fixed the price at Rs 82-84 per share for its Rs 58.80 crore initial public offering (IPO). The IPO will open on July 25 and conclude on July 29. The shares of the company will be listed on BSE's SME platform, Patel Chem Specialities said in a statement. The public issue is entirely a fresh issue of up to 70 lakh equity shares. Proceeds from the issue will be utilised to set up a plant at Indrad, Mahesana, for manufacturing Croscarmellose Sodium (CCS), Sodium Starch Glycolate (SSG) Corn Starch Base & Potato Starch Base and Calcium Carboxymethylcellulose (CMC) and general corporate purposes. Incorporated in 2008, Patel Chem Specialities is engaged in the manufacturing and exporting of pharmaceutical excipients and specialty chemicals. As of FY25, the company has an installed production capacity of 7,200 MT per year, with a capacity utilisation rate of 89 per cent. "The IPO proceeds will