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FDA Issues Warning Letters to Three API Repackers For GMP Violations

 
• By Akriti Seth

FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk with significant violations of manufacturing quality standards.

Quality_Control
Various API repackers have come under scrutiny over quality control issues • Source: Shutterstock

The US Food and Drug Administration has issued warning letters to three repackers of active pharmaceutical ingredients, including opioids, for significant violations of current good manufacturing practice requirements. The companies under question are B&B Pharmaceuticals, Asclemed USA – trading as Enovachem – and Spectrum Laboratory Products.

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research said “the supply chain issues we have found in...

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More from Manufacturing

Sandoz Starts Construction On $440m Slovenian Biosimilars Plant

 
• By Dave Wallace

Sandoz has begun constructing a major biosimilars manufacturing facility in Slovenia that is set to become operational in 2028. A $440m investment in the project adds to local biosimilars initiatives that together total over $1bn, helping Sandoz to move out of the shadow of former parent Novartis.

‘America Leans On Hikma’ And Its $1bn Domestic Drug Manufacturing Investment

 
• By Urtė Fultinavičiūtė

Claiming to be a top-three supplier of sterile injectables in the US, Hikma intends to invest $1bn over the next five years to further expand its American manufacturing base, as the threat of tariffs still looms.

US Tariff Overhang Weighs on Chinese API Exports

 
• By Dexter Jie Yan

Chinese API exports to the US fell by 24% year-on-year to $255m in May, when the US and China called a truce in a previously escalating trade war.

Reshaped Xbrane Allies With OneSource For Commercial Biosimilar Manufacturing

 
• By Dean Rudge

Xbrane Biopharma is partnering with India’s OneSource Specialty Pharma to manufacture its biosimilars, including its much-delayed ranibizumab product Ximluci. The move follows a SEK240m funding round and strategic refocus on commercialization after divesting key R&D assets to Alvotech.

More from Business

Bridging The Void: How Biocon Biologics Sees The Future Of Biosimilars In Europe

 
• By Dave Wallace

As Biocon Biologics picks up the latest approvals in Europe for its Stelara biosimilar, Blake Leitch, the firm’s head of Europe, talks to Generics Bulletin about what lies ahead for Biocon and for biosimilars more widely in the region – including tackling the “biosimilar void”.

Where Art Thou Celltrion? Kabi Pushes Past With US Denosumab Launches

 
• By Dean Rudge

Fresenius Kabi has become the second company to launch US denosumab biosimilars, taking its current biosimilars portfolio up to six products.

‘America Leans On Hikma’ And Its $1bn Domestic Drug Manufacturing Investment

 
• By Urtė Fultinavičiūtė

Claiming to be a top-three supplier of sterile injectables in the US, Hikma intends to invest $1bn over the next five years to further expand its American manufacturing base, as the threat of tariffs still looms.