Explore Business Standard
Dr Reddy’s
Drugmaker Dr Reddy's Laboratories Ltd on Tuesday said it has received establishment inspection report from the US health regulator for its formulations manufacturing facility at Srikakulam in Andhra Pradesh, classifying the facility as voluntary action indicated. The US Food & Drug Administration (USFDA) had conducted a GMP and a Pre-Approval Inspection (PAI) conducted by at the company's formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh, India, intimated to the exchanges on July 18, 2025, Dr Reddy's Laboratories Ltd said in a regulatory filing. "We wish to inform you that the company has received the Establishment Inspection Report (EIR) on October 20, 2025. The USFDA has classified the inspection outcome as 'Voluntary Action Indicated (VAI)'," it said, adding the inspection is officially closed. Under voluntary action indicated (VAI), while objectionable conditions were found and documented during an inspection, the agency is not prepared to take or ...
Six prominent pharmaceutical companies, including Dr Reddy's Laboratories, Aurobindo Pharma, and Hetero Labs, have signed memorandums of understanding (MoUs) with the Telangana government to set up facilities in the Pharma City near here, the government announced on Friday. The companies have committed to invest over Rs 5,260 crore, which is expected to create 12,490 job opportunities in the pharma sector, according to an official release. Representatives from the companies met with Chief Minister A Revanth Reddy and Industries Minister D Sridhar Babu at the Secretariat to finalise the agreements. "The pharma company managements signed MoUs to establish the industries. The six companies expressed their interest to invest more than Rs 5260 crore. The investments will provide 12,490 job opportunities in the pharma sector. The government will allocate land for the establishment of the new pharma manufacturing units in the recognised pharma city, the release said. According to the MoUs
Dr Reddy's Laboratories and Sun Pharma are recalling products in the US due to manufacturing issues, as per the latest Enforcement Report by the US Food and Drug Administration (USFDA). According to the report, Dr Reddy's Laboratories is recalling drugs to treat insomnia and gout in the American market. New Jersey-based Dr Reddy's Laboratories, Inc., a unit of Hyderabad-based drug major, is recalling 13,752 bottles of Eszopiclone tablets, the USFDA stated. The affected lot has been produced at Dr Reddy's Bachupally plant in Telangana. As per the USFDA, the drug firm is recalling the affected lot due to "Failed Impurities/Degradation Specifications". The company issued the Class III nationwide recall on June 4 this year. As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences". Dr Reddy's Laboratories, Inc. is also recalling 20,520 units of Allopurinol tablets in the
Sun Pharma and Dr Reddy's Laboratories are recalling products in the American market due to manufacturing issues, the US Food and Drug Administration (USFDA) has said. In its latest Enforcement Report, the US health regulator stated that a US-based unit of Sun Pharma is recalling 35,069 bottles of medication used to treat high pressure inside the eye due to glaucoma or other eye diseases. New Jersey-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Xelpros (latanoprost ophthalmic emulsion) due to "out of specification for particulate matter test". The company initiated the voluntary Class III recall in the US on April 22 this year, the USFDA stated. In a separate filing, the USFDA stated that a US-based arm of Dr Reddy's Laboratories is recalling 1,176 bottles of an immunosuppressant medication. Dr Reddy's Laboratories Inc is recalling the affected lot of Sirolimus Tablets due to "Failed Impurities/Degradation Specifications", the USFDA said. The company ...