Excipients, raw materials and intermediates

FDA says no to anti-addiction rule on Ritalin, painkillers

FDA says no to anti-addiction rule on Ritalin, painkillers

By Fiona Barry

The US Food and Drug Administration has rejected a petition to force drugmakers to reformulate CNS-acting drugs like Adderall, Ritalin, and painkillers to prevent illegal use, but experts say the rule is only a matter of time.

Evonik invests in Japanese silica capacity

Evonik invests in Japanese silica capacity

By Dan Stanton

Chemicals firm Evonik has expanded its capacity in Japan to cope with high demands for specialty silica, used in various drugmaking operations.

FDA proposed rule could delay import of excipients, PhRMA says

FDA proposed rule could delay import of excipients, PhRMA says

By Zachary Brennan

Although industry group PhRMA has called for the full implementation of a proposed rule that would allow the US FDA to destroy detained drugs deemed to be counterfeit or unapproved, the group also warns that such destruction could lead to manufacturing...

UK generics makers and MHRA pool manufacturing knowledge

UK generics makers and MHRA pool manufacturing knowledge

By Fiona BARRY

The British Generic Manufacturers Association (BGMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) will launch a forum for the generics industry to discuss manufacturing and quality issues.

US FDA issues new bioavailability guidelines

US FDA issues new bioavailability guidelines

By Dan Stanton

The US FDA has published guidance of how sponsors should best document the bioavailability of products for investigational new drug applications (INDs) and new drug applications (NDAs).

Drug firms replaced as Lonza's biggest buyers in 2013

Drug firms replaced as Lonza's biggest buyers in 2013

By Gareth Macdonald

Drugmakers were replaced by buyers of cosmetics, hygiene and material protection ingredients as Lonza’s biggest customers in 2013 according to a report released by the Swiss CMO today.

Gov set on enhancing UK supply chain competitiveness

Gov set on enhancing UK supply chain competitiveness

By Gareth Macdonald

The UK Government has set out to make Britain a more attractive place from which to source drugs and ingredients by awarding a series of taxpayer funded grants to supply chain focused innovation projects.

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