| |SEPTEMBER 20258MAHARASHTRA FDA BOOSTS DRUG TESTING CAPACITY WITH ADVANCED LABSCAPLIN STERILES GETS USFDA NOD FOR GENERIC MILRINONE LACTATE INJECTIONCaplin Point Laboratories Ltd revealed today that its subsidiary Caplin Steriles Ltd has received final approval from the United States Food and Drug Administration (USFDA) for its generic Milrinone Lactate in 5% Dextrose Injection. Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure.The approval is for the abbreviated new drug application (ANDA) for Milrinone Lactate in 5% Dextrose Injection, in 20 mg/100 mL and 40 mg/200 mL single-dose infusion bags. This makes Caplin Steriles' product therapeutically equivalent to Sanofi Aventis US LLC's reference listed drug, PRIMACOR.Milrinone is one of the important treatment options in a hospital environment, allowing health professionals to treat patients that have severe heart failure, and helps to improve heart function. This approval represents a milestone as Caplin Steriles bolsters its injectables portfolio for an aggrieved and highly regulated US market, as it embarks on an expansion in the realm of critical care therapeutics.As per IQVIA (IMS Health) data, Milrinone Lactate in 5% Dextrose Injection, generated sales of about USD 11 million from the US market for the 12 months ended July 2025. While the market size is likely small, the approval illustrates Caplin Steriles strategy to target specialised hospital-based products with reliable demand and less competition.This development highlights Caplin Point Laboratories' continued progress in securing USFDA approvals and reinforces its commitment to bringing cost-effective generic alternatives to the US healthcare system. POTOP STORIESThe Maharashtra Food and Drug Administration (FDA) has made substantial improvements to its testing facilities to address the continued high demand for drug regulation and quality testing.The FDA's laboratories in Mumbai and Aurangabad have been enhanced with high-quality analytical technologies including High-Performance Liquid Chromatography (HPLC), Infrared (IR) spectroscopy, Ultraviolet (UV) spectroscopy, and Liquid Chromatography-Mass Spectrometry (LC-MS).These upgrades, together with additional manpower, will increase the testing capacity and the compliance to safety and quality standards associated with drug testing.In addition to its own upgrades, the FDA has inspected all public testing laboratories licensed by the FDA. The laboratories were all built with quality, analytical equipment in accordance with FDA specifications and provide an invaluable service to a manufacturer who does not have their own testing laboratory and thus, can help provide responsible safety assessments across the public.Maharashtra has three FDA drug testing laboratories in Mumbai (4,000), Aurangabad (2,500), and Nagpur (1,000) and the FDA hopes to increase the annual testing capacity to over 30,000 drug samples. Backed by the Centrally Sponsored Scheme launched in 2016­17 with a total outlay of Rs. 136 crore, this initiative funded 60% by the Centre and 40% by the State is set to further strengthen Maharashtra's drug testing ecosystem before its funding window closes in March 2025."The Pune Divisional Office and Laboratory, along with the Nashik Divisional Office and Laboratory, have completed their civil construction work under the CSS-State Regulatory Scheme.. The government plans to establish one lab per division, and has recently acquired land in Pen (Raigad district) for setting up a dedicated lab for the Konkan division," according to official sources. PO
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