The Spanish Medicines Agency has given Investigational Medicinal Products (IMP) License to Midatech Biogune to manufacture clinical grade nanoparticles at its Bilbao manufacturing facility, Spain.
Unigene Laboratories, a provider of design, delivery, manufacture and development of peptide-based therapeutics, has entered into a clinical manufacturing agreement with Cara Therapeutics.
APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced that it has entered into a commercialization, manufacture and supply agreement with Teva Pharmaceutical USA, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd., to manufacture and market Gemcitabine HCI for Injection. Under the terms of the agreement APP has been granted a license to market Gemcitabine HCI for Injection in 200 mg and 1 g single dose vials during the 180 day Hatch Waxman exclusivity period. APP plans to launch Gemcitabine immediately.
Pharmatek Laboratories, a pharmaceutical chemistry development company, has added spray drying to its drug formulation and manufacturing capabilities.Pharmatek has acquired a Buchi B-290 Mini Spray Dryer for formulation feasibility studies and small-scale clinical manufacture.