PRINCETON, N.J., Sept. 6, 2023 /PRNewswire/ — DifGen Pharmaceuticals LLC (“DifGen”) announced today that it has successfully completed USFDA audit of its manufacturing site in Florida, Aveva Drug Delivery systems – the first audit after it’s acquisition of this facility in April, 2023. Furthermore, DifGen has also successfully launched its first complex oral sublingual/ buccal film – a generic to Suboxone (Buprenoprhine/ Naloxone) in the US market.
In a joint statement, Ramandeep Singh Jaj & Dr. Santhanakrishnan Srinivasan, Founders & Co-CEOs of DifGen commented, “This is a truly remarkable achievement. Two important milestones within just four months of our first ever acquisition and foray into the US manufacturing and marketing space. It was a herculean effort and kudos to our entire team that made this dream a reality. DifGen is committed in establishing and expanding its local US manufacturing base which will provide patients affordable lifesaving medication with highest quality and consistent supply.”
DifGen is a US based Global Pharmaceutical company with a primary focus on developing complex high barrier to entry Generics and Specialty Pharmaceutical products that would help increase accessibility to high quality medication thereby leading to the creation of next generation healthy communities. DifGen consistently aspires to challenge standard thought processes to arrive at dependable solutions that create a paradigm shift in product development, quality, clinical affairs, regulatory sciences, and commercial strategy. The firm has a talented team with some of the brightest minds who have developed a holistic understanding of the nuances associated with the development of unique, commercially viable and difficult product lines across varying therapeutic areas and a broad array of dosage forms such as Injectables, Ophthalmic, Topicals, Biologicals, Drug Devices, Soft Gels, Solid Orals & Suspensions.
Aveva Drug Delivery Systems is a fully integrated developer and manufacturer of Transdermal Delivery Systems (TDS) and oral Dissolvable Films (ODF). Aveva is licensed to manufacture, package and market OTC & Rx TDS and ODF products in the USA & Canada and is DEA approved for Schedule II & III controlled substance storage & handling. Aveva’s licensed facilities located in Miramar, FL is spread across 3 sites totaling 144,000 sq. ft with current installed capacity of ~200m Patches per annum.
SOURCE DifGen Pharmaceuticals