Latest news with #Form483
The Hindu
16 hours ago
- Business
- The Hindu
Granules arm gets U.S. FDA observation resolved
Generic drugmaker Granules India on Saturday said subsidiary Granules Pharmaceuticals Inc. addressed and resolved a U.S. Food and Drug Administration observation during the same inspection when it was issued by the regulator. The U.S. FDA had completed a pre-approval inspection (PAI) for a first to file controlled substance ANDA (abbreviated new drug application) at the facility of Granules Pharmaceuticals Inc. in Chantilly, Virginia, USA from June 23-27 with one Form 483 observation. The subsidiary 'addressed and resolved the observation during the inspection,' the Hyderabad-headquartered parent company said in a filing. Last week the U.S. FDA had issued an observation to Granules India's active pharmaceutical ingredients (API) manufacturing facility in Bonthapally, Hyderabad, which is one of the world's largest single-site paracetamol API manufacturing plants by volume.
Business Standard
20 hours ago
- Business
- Business Standard
Granules India receives one observation from USFDA following inspection at U.S. facility
Granules India announced that its wholly-owned foreign subsidiary, located in Chantilly, Virginia, USA, has received one observation in Form 483 from the United States Food and Drug Administration (USFDA). In a regulatory filing, the company stated that the USFDA conducted a Pre-Approval Inspection (PAI) at the facility from 23 June to 27 June 2025. At the conclusion of the inspection, the USFDA issued a Form 483 with one observation. Granules Pharmaceuticals, Inc. addressed and resolved the observation during the inspection. The official announcement was made on 27 June 2025, after market hours. Granules India is primarily involved in the manufacturing and sale of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs). The companys consolidated net profit rose by 17.3% to Rs 152.03 crore, on a 2.4% increase in total revenue from operations to Rs 1,196.82 crore in Q4 FY25, compared to Q4 FY24. The scrip rose 0.03% to settle at Rs 497.30 on Friday, 27 June 2025.
Business Upturn
a day ago
- Business
- Business Upturn
Granules India clears US FDA Pre-Approval Inspection with zero observations
By Aman Shukla Published on June 28, 2025, 08:49 IST Granules India announced that the US Food and Drug Administration (USFDA) has successfully completed a Pre-Approval Inspection (PAI) at the manufacturing facility of its wholly-owned subsidiary, Granules Pharmaceuticals, Inc., located in Chantilly, Virginia, USA. The inspection was carried out between June 23 and June 27, 2025. The inspection was related to a first-to-file Abbreviated New Drug Application (ANDA) for a controlled substance. At the end of the process, the USFDA issued one Form 483 observation. The company confirmed that the observation was addressed and resolved during the course of the inspection itself. Granules Pharmaceuticals is a key part of Granules India's US operations, and the PAI marks an important step forward in its regulatory pipeline. The resolution of the observation during the inspection reflects the company's preparedness and responsiveness to regulatory standards. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Business Upturn
3 days ago
- Business
- Business Upturn
SMS Pharmaceuticals share jump 6% after its Hyderabad facility clears USFDA inspection with zero observations
By Aman Shukla Published on June 26, 2025, 09:24 IST Shares of SMS Pharmaceuticals surged 6% in early trade after the company announced the successful completion of a USFDA inspection at its Central Laboratory Analytical Services in Gagillapur, Hyderabad. As of 9:23 AM, the shares were trading 5.77% higher at Rs 252.90. The inspection, conducted between June 23 and June 25, 2025, concluded with zero Form 483 observations — a clear indicator of full compliance with USFDA norms. This is the second successful USFDA audit at the lab, underlining the company's robust quality assurance systems and regulatory preparedness. The Central Lab operates as an independent analytical testing facility, serving as a key quality control hub for the company. The clean report from the USFDA reinforces SMS Pharma's strong adherence to Current Good Manufacturing Practices (CGMP) and Good Laboratory Practices (GLP) across its operations. This development boosts investor confidence, as regulatory compliance plays a crucial role in pharmaceutical exports to the US — one of SMS Pharma's key markets. It also strengthens the company's reputation as a trusted global pharmaceutical player, with a sharp focus on quality, safety, and transparency. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
The Hindu
5 days ago
- Business
- The Hindu
Gland Pharma facility in Vizag recieves EIR from U.S. FDA
Gland Pharma's facility in Visakhapatnam, which was earlier this year issued Form 483 with three observations by the U.S. Food and Drug Administration, has since received an establishment inspection report from the agency, the generic injectable focussed company said on Tuesday, a development that saw its shares close 1.43% higher at ₹1,768.75 apiece on the BSE. The receipt of the EIR indicates closure of the U.S. FDA inspection conducted in February, the company said in a filling. A pre-approval inspection (PAI) for sterile active pharmaceutical ingredients (APIs), the U.S. FDA had inspected the facillity from February 19-25 and on conclusion issued a Form 483 with three observations. The company had then said the observations are procedural in nature and it will submit the corrective and preventive actions to the agency within the stipulated period. The observations issued are neither repeated observations nor related to data integrity, Gland Pharma had said.
