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Piramal Pharma has said the US health regulator has issued Form 483 with four observations after inspecting its Telangana-based manufacturing plant. The US Food and Drug Administration (USFDA) conducted an inspection of the company's Digwal (Telangana ) based plant from February 9, 2026, to February 13, 2026. At the conclusion of the inspection, the USFDA issued a Form-483, with four observations, Piramal Pharma said in a regulatory filing on Friday. These observations are related to enhancement in procedures and not related to data integrity and indicated to be classified as a VAI (voluntary action indicated), it added. The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines, the drug maker stated. Piramal Pharma remains committed to maintaining the highest standards of compliance and will work closely with the agency to comprehensively address all the observations, it added. As per the USFDA, Form 48
Pharma companies will no longer ne required to seek a test licence and may proceed with pharmaceutical development upon submitting an online intimation to CDSCO, except in certain cases, as part of broad simplication notified by the Union Health Ministry. Union Health Ministry has notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, aimed at simplifying regulatory processes, reducing approval timelines, and enabling faster conduct of clinical research and pharmaceutical development in the country. The amendment is line with the directions of Prime Minister Narendra Modi to reduce regulatory burden and promote Ease of Doing Business, the ministry sais Under the existing regulatory framework, pharmaceutical companies are required to obtain a test licence from the Central Drugs Standard Control Organization (CDSCO) for the manufacture of small quantities of drugs intended for examination, research, or analysis purposes. Through the notified amendments, thi
Biotech firm Biocon on Thursday said it has raised Rs 4,150 crore through a Qualified Institutions Placement (QIP) process. The initiative saw issuance of 1,12,664,585 equity shares of face value Rs 5 each to eligible qualified institutional buyers at the issue price of Rs 368.35 per share, the Bengaluru-based firm said in a regulatory filing. The QIP, which opened on January 12 and closed on January 14, attracted strong investor interest from a broad mix of domestic and international participants, reflecting robust confidence in the company's growth prospects, it added. The proceeds from the QIP will be primarily utilised to meet the cash consideration payable to Mylan Inc. (Viatris) for buying out its shareholding in Biocon Biologics Ltd, including repayment of debt availed in this regard, Biocon said. The company recently announced its board has approved a strategic corporate action to acquire all remaining minority shareholdings, including Viatris' stake, thereby making Biocon