Leading Producer of Controlled Substance APIs Now Supplying Lisdex API to Generic Drug Manufacturers Preparing for the 2023 Patent Expiry of Top-Selling Branded ADHD Therapy WILMINGTON, ...
WEST SACRAMENTO, Calif., March 13, 2025 /PRNewswire/ — Gemini Bioproducts, LLC (“GeminiBio”), a biopharma and advanced therapy raw materials supplier, and a portfolio company of BelHealth Investment ...
Akadeum has been successfully customer-audited per US and EU GMP standards, and the products meet endotoxin, sterility, and viral requirements per USP and ICH standards. As expected for raw materials ...
Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S.
Hamburg, Germany, September 25, 2023 – Cellbox Solutions GmbH, a leading provider of warm chain logistics solutions for the research, development and shipment of cell-based therapies and cellular ...
The Final Q-Sub Guidance provides comprehensive guidance on the Q-Sub process and finalizes the draft guidance regarding the Q-Sub program that was issued on March 15, 2024, with minimal changes from ...
OTTAWA, Ontario--(BUSINESS WIRE)-- BWXT Medical Ltd. has submitted a Drug Master File (DMF) to the U.S. Drug and Food Administration (FDA) for No Carrier Added (n.c.a.) Actinium-225 (Ac-225) Active ...
Paris-based medical device startup Tulyp Medical has emerged from stealth and submitted a 510(k) application to FDA for its intelligent pressure-driven perfusion device. The company has seen positive ...
Submission represents an important step towards establishing the Cellbox Live Shipment Technology as a new standard for warm chain logistic in the cell therapy sector Cellbox customers can now ...
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