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Compliance
After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.
After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.
Clinical-stage reformulation specialist Lipella Pharmaceuticals has insisted that “our commitment to our shareholders, our mission, and our clinical goals has not changed” after its common stock was delisted from the Nasdaq Capital Market.
Dr. Reddy's Laboratories preps for potential US tariffs, focusing on sustaining product supply and collaborating with customers on inventories. A recent US plant sale, the firm stressed, was unrelated to tariffs and underlines its openness to ‘make in the US’, where it launched 18 products in fiscal 2025.
Dr. Reddy's Laboratories preps for potential US tariffs, focusing on sustaining product supply and collaborating with customers on inventories. A recent US plant sale, the firm stressed, was unrelated to tariffs and underlines its openness to ‘make in the US’, where it launched 18 products in fiscal 2025.
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.
Spanish competition regulator the CNMC has announced an investigation into Sandoz and its Bexal subsidiary – as well as Alliance Healthcare España and Bluetab Solutions – over sharing sensitive commercial information relating to pharmacy orders for generics.
The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?
The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.
Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”