SWEDESBORO, N.J.--(BUSINESS WIRE)--Wedgewood Pharmacy has reached a definitive agreement to purchase the San Jose, California-based assets of Leiters Enterprises. These assets comprise the equipment and facilities in a 22,000 square-foot, FDA-registered 503B outsourcing facility that is licensed in 45 U.S. states. The company will operate as Wedgewood Connect. Wedgewood Pharmacy has begun the rigorous work of validating processes and preparations for production of its medications in the San Jose facility. Wedgewood Connect expects to begin releasing preparations in the fourth quarter of 2020, including sterile injectables and ophthalmics, none of which were previously produced by Leiters. The transaction is expected to close on or before June 30.
The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for Neptra, from Bayer Animal Health GmbH, a new product for the treatment of canine otitis externa caused by susceptible strains of bacteria sensitive to florfenicol and fungi sensitive to terbinafine.
MENADIONA obtained a new CEP (Certificate of Suitability to European Pharmacopeia) from the European Directorate for the Quality of Medicines and Health Care (EDQM), for the Pharmaceutical Active Ingredient AZAPERONE, which is manufactured in our site located in Palafolls (Barcelona).