Ipca Laboratories Ltd.

New Delhi: Ipca Laboratories on Friday said the US health regulator has issued a Form 483 with three observations after inspecting its Maharashtra-based API plant. The US Food and Drug Administration ( USFDA ) conducted the inspection of the active pharmaceutical ingredients (APIs) manufacturing facility at Tarapur (Maharashtra) from December 1-5, 2025. At the conclusion of the inspection, the USFDA issued a Form 483 with three observations, the drug firm said in a regulatory filing. The company will submit its comprehensive response on these observations to the USFDA within the stipulated time and will work closely with the agency to resolve these issues at the earliest, it added. As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and related Acts. Ipca shares were trading 0.19 per cent down at Rs 1,454.35 apiece on BSE in mid-session deals. PTI

Unichem Pharmaceuticals voluntarily recalled one lot of the muscle relaxant cyclobenzaprine hydrochloride due to a labeling mix-up. The U.S. subsidiary of India’s Unichem Pharmaceuticals is voluntarily recalling one lot of the muscle relaxant cyclobenzaprine hydrochloride after a labeling snafu.The lot being recalled is identified as #GMML24026A. While the labels indicate the bottles contain 10-mg tablets of cyclobenzaprine, at least one label was placed on a bottle filled with 7.5-mg tablets of meloxicam, according to the company's Aug. 27 recall announcement.Meloxicam is used to treat osteoarthritis, rheumatoid arthritis and juvenile rheumatoid arthritis.Meloxicam tablets are light yellow and flat with a beveled edge, while cyclobenzaprine tablets are blue, round, film-coated and have a debased “U” on one side and the number “12” on the other, the company noted.The products were distributed nationwide in the U.S.Patients who mistakenly take meloxicam could experience cardiovascular, gastrointestinal, renal and other side effects, particularly for those who are on nonsteroidal anti-inflammatory drugs and/or blood thinners.So far, Unichem says it has received no reports of adverse effects related to the recall. Unichem said it's using a third-party provider, Inmar, to notify and accept returns of the recalled drug.

By Kashish Tandon Bengaluru: Indian pharmaceutical stocks fell 4.4% on Friday, wiping out gains from the previous session, after U.S. President Donald Trump threatened steep tariffs on the sector. "Pharma (tariffs) is going to be starting to come in, I think, at a level that you haven't really seen before," Trump told reporters aboard Air Force One. "That will be announced in the near future, and is under review right now," Trump said. The index was among the top sectoral losers by percentage on the benchmark Nifty 50, which was down about 1.2% at 11:25 a.m. IST. All 20 constituents of the pharma index were trading in the red, with Sun Pharma , Dr Reddy's and Cipla being the biggest drags. Lupin, Aurobindo Pharma and Ipca Laboratories fell about 6.5% each, and were the top losers by percentage. Trump imposed a 10% tariff on most U.S. imports earlier this week, as well as much higher levies on dozens of rivals and allies alike, but temporarily exempted some goods, including pharmaceuticals, benefiting major exporters including India, Japan and Ireland. Pharma stocks were a rare bright spot on Thursday as global drugmakers gained on relief that their products remained temporarily shielded from the tariffs. However, executives and analysts had warned it was premature to celebrate as levies were still likely to come. "If these tariffs are introduced, the manufacturers will have no choice but to pass on the impact to consumers," said Vishal Manchanda, an analyst at Systematix Institutional Equities. Indian drugmakers have been on a 'wait and watch' mode and also raised concerns on the difficulty in setting up manufacturing in the U.S., a move that would increase their costs. Trump in his Wednesday address had predicted pharma companies would come "roaring back" to the U.S, and warned that "they got a big tax to pay" if they don't. (Reporting by Kashish Tandon in Bengaluru; Editing by Varun H K)