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  • Regulatory NewsRegulatory News

    Capsule Supplier Changes: FDA Offers an Updated Policy

    Changing the supplier of gelatin capsules used to encase drugs constitutes a minor change, and does not require a prior approval supplement (PAS), according to a US Food and Drug Administration (FDA) policy that went into effect Monday. Prior Approval Supplement When a drugmaker makes changes to an already approved product, including changes to its specifications, manufacturing process or label, the company must notify FDA of the change. Depending on the seriousness of...
  • Regulatory NewsRegulatory News

    French Regulators Suspend Catalent Manufacturing Site

    France’s health product regulator, l’Agence National de Sécurité du Médicament et des produits de santé (ANSM), suspended production at contract manufacturer Catalent’s softgel capsule manufacturing facility in Beinheim, France, on Friday. The suspension of the site, which the company says it’s unable to predict the duration of, came because of “out-of-place softgel capsules in several product batches that were detected during quality control procedures and removed prior...
  • Regulatory NewsRegulatory News

    Generic Drugs Should Look Similar to the Drugs They Reference, FDA Says

    The US Food and Drug Administration (FDA) is recommending drugs made by generic manufacturers closely mimic the physical attributes, including the size, shape and color, of the drugs they reference. Background When FDA approves an abbreviated new drug application (ANDA), it does so primarily on the basis of a drug's bioequivalence to the Reference Listed Drug (RLD), the drug to which the generic is compared. Data must show a drug contains the same active ingredient, in ...
  • South Korea Scrambles to Strengthen Import Controls as Capsules Seized Containing Human Flesh

    South Korea is moving to quickly strengthen its import controls after encountering repeated attempts to smuggle in drug products containing the powdered remains of deceased human flesh, reports The Korea Times . "The Korea Customs Service (KCS) said it apprehended 29 smugglers, who disguising themselves as tourists and attempted to bring some 11,000 capsules into Korea in their luggage," wrote The Korea Times . "Six people used international parcels to smuggle in the m...
  • After Crackdown on Counterfeits, a 'River of Pills'

    Regulatory Focus and other media outlets reported on 24 April about China's crackdown on counterfeit medications, which found dozens of manufacturing facilities using industrial-grade gelatin in pharmaceutical capsules. Now Chinese authorities have found something else that is perhaps even more surprising: a small river filled with millions of discarded drug capsules. Gizmodo reports 300 meters of an open sewer ditch were transformed overnight into a "rainbow river,"...
  • China Probe Into Chromium-Laced Capsules Escalates, 77M Capsules Seized

    Chinese regulatory authorities have announced the expansion of a probe into pharmaceutical capsules illicitly laced with Chromium, saying they have arrested nine more people, detained a further 45 and seized more than 77 million capsules, reports Reuters . Chromium is a heavy metal that has been associated with cancer in some circumstances. Chinese authorities originally announced on 15 April that they had found 13 pharmaceutical products-including antibiotics-to have b...
  • China Finds 13 Drugs Made With Excessive Levels of Chromium

    China's State Food and Drug Administration (SFDA) announced 15 April it had found 13 pharmaceutical products to have been manufactured with excessive levels of chromium and was suspending the sale of those products, reports The Wall Street Journal . The chromium was found to have emanated from drug-capsule manufacturers in the Zhejiang province in China, which were reported to be using industrial gelatin instead of gelatin marked for human consumption. The industrial-gr...