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Chemxpert database is a techno-commercial information platform developed and operated by Lifescience Intellipedia Pvt. Ltd. Our data provides valuable insights regarding sourcing, marketing, development, and regulatory functions for the entire Lifescience industry. The different industries covered by our data encompass APIs, FDFs, pharma intermediates, paints, dyes, polymers, biotechnology, biochemical, food additives, nutraceuticals, etc.

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You can gain access to the Chemxpert database after subscribing to it by visiting this link: - https://chemxpert.com/pricing

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The Chemxpert database covers more than 200 countries. We are working in the direction of expanding our data coverage in more countries.

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The different sources we use for data collection are as follows: - • Primary researc • DMF, ANDA, & CEP list • Conferences, Exhibitions, & Tradeshow • Company annual reports • DMF, ANDA, & CEP list • Subject matter experts & KOL survey. Apart from these, our other valuable sources include application-wise manufacturers list, subscribed and non-subscribed databases, corporate partners, US FDA Orange book, publicly available sources, industry associates, national statistics, regulatory websites, etc. You can gain access to the Chemxpert database after subscribing to it by visiting this link: -https://chemxpert.com/sources

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Your Chemxpert account will be activated instantly if the payment is made through our website. If you choose to use RTGS, NEFT, or IMPS systems for payment, your account will be activated within 24 hours.

31 Jan 2020
Admin
News Article

FDA faults Biocon small molecule API facility during preapproval review

The FDA has found a handful of issues with Bioconâ€™s small molecule API facility in Bengaluru, India. The company today reported that the agency issued a Form 483 with five observations following a preapproval and good manufacturing practices inspection last week of its small molecule API facility. It didnâ€™t say what product it is hoping to get approved for production at the plant or what the issues are but pledged to get on them. â€œWe will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously. We remain committed to global standards of Quality and Compliance,â€ Biocon said in a statement. RELATED: Mylan's Lantus copy derailed in U.S. again by manufacturing ills Biocon has had some other issues with manufacturing. Just days earlier, in its quarterly report, Biocon pointed out that in August the FDA had issued an Establishment Inspection Report from the FDA stating the agency had closed its inspection of the Biologics Drug Product facility in Bengaluru. In December, the agency greenlighted the facility to manufacture the drug substance for Fulphila (pegfilgrastim), which it is making for Mylan. The drug, a blood cell booster for cancer patients, is Mylanâ€™s knockoff of Amgenâ€™s Neulasta. EDITOR'S NOTE: The story was updated to indicate that the observations were for Biocon's small molecule API facility and not its biosimilar's plant.

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