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UK's CMA Goes After Advanz, Morningside And Alliance On Nitrofurantoin

 
• By Dave Wallace

The UK’s Competition and Markets Authority has issued a statement of objections to Advanz, Morningside and wholesaler Alliance Healthcare after provisionally finding that the firms broke competition law by arranging to carve up the UK market for nitrofurantoin.

CMA
The CMA Has Issued A Statement Of Objections To Three Firms • Source: Shutterstock

The UK’s Competition and Markets Authority has provisionally found that AMCo – now part of Advanz Pharma – as well as Morningside and wholesaler Alliance Healthcare “broke competition law by arranging to carve up the market between them” for nitrofurantoin from 2014 until at least 2017, according to a statement of objections revealed by the regulator this morning.

Pointing to the three firms’ “illegal market sharing” in the supply of the antibiotic, the CMA alleged that the companies entered into arrangements under which Alliance Healthcare would buy equal volumes of

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US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

‘We Can’t Keep Going On Like This’ – Biosimilars Forum’s Reed Calls For Urgent Changes In US

 
• By Dave Wallace

As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.

UK-India FTA Could Offer ‘Significant Benefits’ For Generics And Biosimilars

 
• By Dave Wallace

A free trade agreement struck between the UK and India could over “significant benefits for the generic and biosimilar sectors,” Medicines UK believes. The off-patent industry association has also suggested further avenues for collaboration between the two governments on regulatory pathways and supply security.

US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

More from Policy & Regulation

Cutting Out The Middlemen? Trump’s Pricing Order Offers Opportunity On PBMs

 
• By Dave Wallace

Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.

US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Trump Order On Domestic Manufacturing Wins Plaudits From Industry

 
• By Dave Wallace

An executive order from US president Donald Trump aimed at incentivizing domestic manufacturing of critical medicines has been welcomed by the US Association for Accessible Medicines.