| |NOVEMBER 20258BIOCON'S API PLANT GETS 2 FDA OBSERVATIONS AFTER INSPECTIONTORRENT PHARMA GETS CDSCO NOD FOR PRUCALOPRIDE ORAL SOLUTIONTorrent Pharmaceuticals got the green light from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to produce and sell Prucalopride Oral Solution (0.2 mg/mL).The go-ahead is in line with a decision by the SEC dated July 29, 2025, when the company provided a full safety dossier illustrating the synergistic effect of the excipients - propylene glycol, glycerol, and sorbitol - used in the tested formulation.After going through the material, the Gastroenterology and Hepatology panel of experts, to whom the questions were referred, had a detailed discussion and unanimously agreed to grant permission for the manufacture and marketing.Prucalopride is a serotonin 5-HT4 receptor agonist which is used in the treatment of chronic idiopathic constipation in adult patients. It is a selective stimulator of 5-HT4 receptors and does not affect the hERG channel or 5-HT1 receptors, thereby, greatly reducing the cardiovascular risks, which were the cause of earlier drugs of the same class.One of the main excitatory neurotransmitters, acetylcholine, is released as Prucalopride, through its 5-HT4 receptors located all over the gastrointestinal tract - mainly in smooth muscle cells and the myenteric plexus - stimulates muscle contraction. This leads to the muscle contractions working together to achieve bowel movement.The SEC's approval is a significant milestone for Torrent Pharma as it strives to broaden its gastroenterology portfolio and thus, extend its commitment to the Indian pharmaceutical sector by introducing novel therapies. POTOP STORIESBiocon Ltd. informed that its Active Pharmaceutical Ingredient (API) manufacturing facility in Visakhapatnam, Andhra Pradesh, has received two observations from the United States Food and Drug Administration (US FDA) consequent to a routine inspection.It the biopharmaceutical company's local regulatory filing, the medical regulator in the United States conducted a GMP surveillance inspection at the manufacturing site from November 3 to November 7, 2025. The inspection was completed with the issuance of two observations recorded in Form 483. Form 483 usually indicates that the points raised in the conversations or documentation require corrective actions.Biocon pointed out that the observed issues are not anticipated to significantly affect the company's business activities. The organization pledged that it is taking necessary measures to resolve the issues referred to by the US FDA within the given period."The company continues to be very much alive to the need to uphold the quality and compliance standards at its various manufacturing units," Biocon stated in its report.Biocon's factory in Visakhapatnam is a significant contributor to the company's global API supply chain, which serves both regulated and emerging markets. The company is subject to regular inspections by regional and international regulatory authorities as part of its ongoing compliance framework, which ensures adherence to global quality standards.This news is consistent with the narrative of Biocon staying the course towards manufacturing excellence and regulatory alignment, thus solidifying its status as a major player in the biopharmaceutical industry globally. PO
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