API
FDA project will examine abuse-resistant formulations
August 13, 2013Manufacturing and Production API, CDC, FDA
The FDA is seeking tenders for a research project to examine how effective tamper-resistant formulations of opioid analgesics really are …
Fresenius Kabi hit by second FDA warning letter
July 10, 2013Manufacturing and Production API, FDA, Fresenius Kabi, GMP
German generic drugmaker Fresenius Kabi has been sent another warning letter from the FDA citing deficiencies at a manufacturing plant. …
US gains exemption from EU requirements on API imports
June 25, 2013Manufacturing and Production API, FDA, hamburg
The US has joined the short list of countries from which suppliers can ship active pharmaceutical ingredients into the EU …
UK takes action to prevent API shortages
June 20, 2013Manufacturing and Production API, MHRA, shortages
The UK has unilaterally adopted a policy of allowing imports of active pharmaceutical ingredients (API) on the strength of pharmaceutical …
Boehringer held up by FDA for production violations
May 24, 2013Manufacturing and Production API, Boehringer, FDA
Boehringer Ingelheim has pledged to resolve manufacturing compliance issues at a facility in Germany uncovered by the US Food and …
Canada tightens GMP rules for active ingredients
May 21, 2013Manufacturing and Production API, Canada, GMP
Canada’s Food and Drug Regulations have been amended to extend the requirements for Good Manufacturing Practices (GMP) to active pharmaceutical …
ABPI supply chain warning
March 7, 2013Manufacturing and Production, Sales and Marketing ABPI, API, EFPIA
The ABPI is warning of supply chain problems which may cause a bottleneck in UK pharma manufacture this summer. The …
Lonza earmarks $15m for ADC plant expansion
January 14, 2013Manufacturing and Production ADC, API, Lonza, Novasep
Swiss contract manufacturer Lonza has said it will invest around 14 million francs ($15m) in new capacity for antibody drug …
Questcor buys API specialist BioVectra for $51m
January 8, 2013Manufacturing and Production API, Achtar, BioVectra, Questcor
US biopharma firm Questcor has signed a deal to acquire Canadian active pharmaceutical ingredient (API) manufacturer BioVectra for an upfront …
Evonik swings axe at API plant
December 18, 2012Manufacturing and Production API, Evonik, cuts, lilly
Fine chemicals company Evonik Degussa has announced job cuts as part of an efficiency drive at a US plant making …
Switzerland first to pass EU’s ‘equivalence’ test for APIs
December 12, 2012Manufacturing and Production API, China, EU, FMD, MHRA
Switzerland has become the first country to be classed as having equivalent standards for the manufacture of active pharmaceutical ingredients …
UCB sells Indian production plant to Exemed
November 27, 2012Manufacturing and Production API, Exemed, UCB, vapi
UCB Pharma has signed a deal to sell its manufacturing facility in Vapi, India, to local firm Exemed Pharmaceuticals. The …
EFCG calls for mandatory inspection of API plants
November 13, 2012Manufacturing and Production API, EFCG, EU, FMD
The European Fine Chemicals Group (EFCG) has called for all active pharmaceutical ingredient (API) manufacturing facilities to undergo mandatory inspections. …
Mylan buys Indian oncology plant for $33m
October 18, 2012Manufacturing and Production API, Mylan, SMS
Indian contract research and manufacturing services (CRAMS) company SMS Pharmaceuticals has sold its manufacturing facility in Andhra Pradesh to US …
BASF to make catalysts in India
October 15, 2012Manufacturing and Production API, BASF
BASF says it is planning to open a new production line in India next year that will make catalysts used …
