India’s generic-drug dominance is being squeezed as the US and Europe push for newer, tougher-to-manufacture molecules under stricter FDA compliance. Instead of building plants, Hyderabad-based HRV Pharma is banking on “drug visas,” or FDA DMFs that act as regulatory licenses for exporting active ingredients. The company, which owns no factories, operates in 55 countries and holds 66 DMFs, charging other manufacturers for the regulatory work—turning compliance into a scalable asset.
Straus Creamery has launched a voluntary ice cream recall affecting specific flavors and sizes sold across 17 US states, after the possible presence of metal fragments was detected. The company announced the recall on May 14 and the FDA published the notice on May 15. Importantly, only particular production runs identified by “best by” dates are included—consumers are urged to discard the affected items and not return them to stores. No injuries have been reported.
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Investigators probing the Mumbai family deaths have shifted gears after FDA testing found no additives or contaminants in watermelon, biryani, and other samples. With food adulteration ruled out, forensic teams are now conducting deeper tests for microbial toxins or other poisonous substances that could explain the rapid deterioration and deaths. The new focus may redefine what triggered the tragedy.
A federal appeals court has restricted access to mifepristone by blocking the mailing of prescriptions for the abortion pill. The ruling effectively requires patients to obtain care through in person clinic visits, affecting telemedicine abortion access, enforcement of state bans such as Louisiana’s, and related miscarriage care, while intersecting with FDA rules governing use of the medication.
Lupin has launched generic anti-diabetic tablets in the United States—dapagliflozin and metformin hydrochloride extended-release—after receiving FDA approval. The company says its product is bioequivalent to Xigduo XR, positioning the launch as a potential new option for diabetes patients seeking effective treatment in the US market.
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