The US Food and Drug Administration (FDA) just launched a new webpage to share recent actions and activities related to complex generic drugs to spur their development. “Since these products are ...

The US Food and Drug Administration (FDA) needs to develop guidance on post-approval changes for complex generics, and to update its guidance on post-approval changes for non-complex generics as ...

The generic medication was developed through a strategic partnership with Orbicular Pharmaceutical Technologies.

Apotex Corp. today announced it has received the first U.S. Food and Drug Administration (FDA) Tentative Approval for its Abbreviated New Drug Application (ANDA) for Semaglutide Injection, marking a ...

Mumbai, Nov. 22 -- The inspection concluded with a Form-483, citing seven observations. Lupin stated that it will address the observations and respond to the FDA within the stipulated timeframe, and ...

Partner Apotex Corp. (Apotex) to market and distribute to the U.S. healthcare market ...

OneSource Specialty Pharma has announced that its partner, Orbicular Pharmaceutical Technologies, along with its U.S.-based ...

Apotex and two partners advanced a complex sterile injectable program designed for use in parenteral nutrition.

Orbicular's Ozempic generic receives tentative FDA approval, to be marketed in the U.S. by Apotex, enhancing diabetes treatment options.

DifGen Pharmaceuticals LLC, a U.S.-based specialty generic pharmaceutical company today announced that its partner, Apotex Inc., has received final approval from the U.S. Food and Drug Administration ...