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APIs (active pharmaceutical ingredients)

News headlines

Tetraphase hires Patheon to make its synthetic antibiotic eravacycline

22-Jun-2017 - Tetraphase Pharmaceutical has hired Patheon UK Limited to make and test the synthetic antibiotic eravacycline.

US FDA slams Chinese API maker over data breaches

22-Jun-2017 - Qinhuangdao Zizhu omitted, deleted and manipulated manufacturing data at its active pharmaceutical ingredient plant in Hebei, China according to the US FDA.

Pfizer recalls injectables made at Rocky Mount over potential contamination risk

19-Jun-2017 - Pfizer has recalled four injectables – including the already scarce heart surgery drug Sodium Bicarbonate - made at Hospira's facility in Rocky Mount, North Carolina after identifying a potential contamination risk.

A change of focus: B-MS sells Irish API plant to Korean SK Biotek

19-Jun-2017 - Bristol-Myers Squibb (B-MS) has announced it will sell its Swords, Ireland-based API manufacturing facility as part of its focus on biologics.

Update with comment from MHRA

Europe tells API firms UK will be a “third country” like India and China after Brexit

15-Jun-2017 - The European Commission has confirmed that UK drug ingredient manufacturers will have to supply European customers with written confirmation their products are made in compliance with EU standards after Brexit.

Dr Reddy's says US FDA has closed Miryalaguda plant audit

14-Jun-2017 - Dr Reddy’s Laboratories says it has addressed the problems that earned its API plant in Miryalaguda, Talangana a US FDA Form 483 earlier this year.

News in brief

Johnson Matthey teams with Intrexon to make peptide API production more efficient

13-Jun-2017 - Johnson Matthey and Intrexon Corporation have teamed up to develop peptide active pharmaceutical ingredient (API) production methods.

Eurofins buys drug ingredient contractor Alphora Research

13-Jun-2017 - Eurofins Scientific has acquired drug ingredient manufacturing and testing services firm Alphora Research, Inc.

Update - BioMarin to hire 50 people at Shanbally

US FDA clears BioMarin to make $380,000-a year Vimizim in Ireland

12-Jun-2017 - The US FDA has cleared BioMarin Pharmaceutical Inc. to make the enzyme replacement drug Vimizim (elosulfase alfa) at its plant in Cork, Ireland.

ABPI wants UK minority Government to put pharma at heart of Brexit talks

12-Jun-2017 - Pharmaceuticals should be at the heart of Brexit talks says the Association of the British Pharmaceutical Industry, which has pledged to work with the UK’s minority Government.

'Talking' smart pill looks to overhaul prescription opioid space and stop abuse

08-Jun-2017 - Pop Test Abuse Deterrent Technologies has received a patent for an opioid drug delivery and abuse deterrent ‘smart pill’ it says can prevent death, theft, diversion and counterfeiting.

Acasti and CordenPharma look to continuous production for omega-3 drug

06-Jun-2017 - Continuous manufacturing equipment installed at a CordenPharma French facility has reduced cycle time and cost of making a hypertriglyceridemia drug, says Acasti Pharma.

Takeda breaks ground on $45m Ninlaro plant in Ireland

06-Jun-2017 - Takeda has begun construction of an Irish facility to support production of its orally delivered blood cancer peptide Ninlaro (ixazomib).

Cambrex continues to up capacity with more than $200m invested in 5 years

31-May-2017 - Cambrex Corporation has increased new capacity at its Sweden-based cGMP as the manufacturer focuses on market demand and customer need, says VP.

Cure Pharma’s API delivery tech on the tip of the tongue

30-May-2017 - Cure Pharmaceutical has submitted a patent application for an oral film delivery technology it says can combine several active pharmaceutical ingredients without negative interaction. 

US ban for Changzhou Jintan Qianyao raises questions about customers says expert

24-May-2017 - The US FDA has banned APIs made by Changzhou Jintan Qianyao Pharmaceutical Raw Materials after staff told inspectors their quality testing plans were “in their heads.”

Granules India confirms $35m US plant expansion will create jobs

24-May-2017 - Granules India says adding manufacturing capacity at its facility in Virginia, US will create 102 jobs.

US FDA rejects Sun epilepsy drug due to ongoing problems at Halol plant

24-May-2017 - The US FDA has refused to reapprove Sun Pharma Advanced Research LTD’s epilepsy drug Elepsia XR (levetiracetam) citing problems at its plant in Halol, India.

DSM Sinochem wins patent infringement ruling against Sinopharm Weiqida

23-May-2017 - The High Court of Delhi, India, has granted a permanent injunction against Sinopharm Weiqida Pharmaceutical for patent infringement of DSM Sinochem Pharmaceuticals’ enzyme-based antibiotic production IP.

IFPMA launches Alliance to track drug firms' progress in the fight against ‘superbugs'.

Charity urges drug industry to consider supplier role in “superbug” spread

18-May-2017 - Drug manufacturers, retail pharmacies and regulators have a role to play in curbing antimicrobial resistance say campaigners urging industry to ensure their API suppliers are not part of the problem.

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