has been granted ANDA approval by the United States Food and Drug Administration for Pilocarpine Hydrochloride Ophthalmic Solution USP, 1%, 2%, and 4% (15 mL).
company has completed the acquisition of 85,00,000 equity shares of face value of ₹10 each of Apollo Gleneagles PET-CT (AGPCL), held by its existing shareholder Parkway Healthcare (Mauritius), representing 50 per cent of the total paid-up equity share capital of AGPCL. With this, AGPCL has become a wholly-owned subsidiary of the company.
has received a positive recommendation from the Subject Expert Committee (SEC) (Neurology & Psychiatry) of the Central Drugs Standard Control Organisation (CDSCO) to initiate Phase III clinical trials for Suvorexant tablets, available in strengths of 5mg, 10mg, 15mg, and 20mg. The company is the first in India to receive the regulatory nod for Suvorexant, a prescription medication used to treat insomnia in adults. It works by modulating the sleep-wake cycle through the central nervous system, promoting improved sleep onset and maintenance.
has received permission from the Central Drugs Standard Control Organisation to import Trastuzumab Deruxtecan 100mg/5mL vial lyophilised powder for sale and distribution (Brand name: Enhertu) .
said it has received demand notices of over ₹6.63 crore from the National Pharmaceutical Pricing Authority (NPPA). The demand notices issued are under Para 15 of the Drug Price Control Order 2013 (DPCO). It alleges overcharging for five drugs “between January 2016 to November 2018, it added.
The US health regulator has issued a Form-483 with four observations after inspecting Pithampur Unit-2 manufacturing facility. The US Food and Drug Administration (USFDA) inspected the facility from July 8 to 17, 2025, and closed with the issuance of a Form-483 with four observations, the Mumbai-based drug maker said in a regulatory filing. “We would like to update that US FDA has determined the inspection classification of this facility as ‘Official Action Indicated (OAI)‘,” the drug maker said.
The stalled open offer for a 26.1 per cent stake in by IHH Healthcare Berhad has been approved by the capital market regulator SEBI, seven years after the Malaysian firm acquired 31.1 per cent in the Indian hospital chain, according to a regulatory filing on Friday. The Securities and Exchange Board of India, pursuant to its letter dated October 1, 2025, has approved IHH’s request to proceed with an open offer for Fortis Healthcare and its arm Fortis Malar Hospitals, IHH Healthcare Berhad said in a filing to the Malaysian Stock Exchange. The same was shared on BSE by Fortis Healthcare.