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DifGen Pharmaceuticals Finalizes FDA Audit of Manufacturing Site

Launches first complex oral sublingual/buccal film, a generic to Suboxone (Buprenoprhine/Naloxone) in the U.S. market.

DifGen Pharmaceuticals LLC, a global pharmaceutical company with a primary focus on developing complex high barrier to entry generics and specialty pharmaceutical products, completed a U.S. FDA audit of its manufacturing site in Florida, Aveva Drug Delivery systems. This is the first audit after its acquisition of this facility in April 2023.

In addition, the company successfully launched its first complex oral sublingual/buccal film – a generic to Suboxone (Buprenoprhine/ Naloxone) in the U.S. market.

In a joint statement, Ramandeep Singh Jaj and Santhanakrishnan Srinivasan, founders & co-CEOs of DifGen said, “This is a truly remarkable achievement. Two important milestones within just four months of our first ever acquisition and foray into the U.S. 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 U.S. manufacturing base which will provide patients affordable lifesaving medication with highest quality and consistent supply.”

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