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APIs (active pharmaceutical ingredients)

News headlines

Italian PM's resignation will hit API sector if anti-EU party takes power says expert

05-Dec-2016 - Italian PM Matteo Renzi has quit after voters rejected his controversial plan for parliamentary reforms, setting the stage for political and economic turmoil.

Takeda to build €40m Irish plant for global Ninlaro API supply

05-Dec-2016 - Takeda will build a high containment production facility at its site in Dublin, Ireland to support the manufacturing of its oncology product Ninlaro (ixazomib).

Opinion

Ita-leave? Italian referendum may impact European API supply chain

02-Dec-2016 - A ‘no’ vote in the Italian constitutional referendum this weekend may hurt the country's API industry and impact European drug supply chains.

US FDA slams Dongying Tiandong for poor raw heparin supplier oversight

30-Nov-2016 - Dongying Tiandong Pharmaceutical Co., Ltd does not do enough to ensure the crude heparin it uses is free potentially lethal contaminant OSCS according to the US FDA.

ICH completes draft Q11 implementation Q&A; welcomes ANVISA and MFDS

29-Nov-2016 - The ICH has put together a draft Q&A document to clarify Q11 guidelines on drug active ingredient production.

News in brief

AMRI signs second API supply deal with Shire

29-Nov-2016 - AMRI has signed a second deal with Shire plc under which it will supply an undisclosed active pharmaceutical ingredient (API).

update

Patheon buys Roche's Xeloda API plant and signs supply deal

29-Nov-2016 - Patheon has bought a US API facility from Roche in a deal that will also see the CMO supply the Swiss firm with drug ingredients.

Japan to share API plant inspection data with international regulators

28-Nov-2016 - European Union and Japanese regulators have announced they will share details of API manufacturing facility inspections.

US FDA clears Lupin to supply US with meds made in Goa

28-Nov-2016 - The US FDA has cleared Lupin to restart production of drugs for the US market at its plant in Goa after the Indian firm fixed problems observed by agency inspectors.

US FDA says Srikem plan will not fix data integrity issues at Taloja plant

24-Nov-2016 - The US FDA still has doubts about Srikem Laboratories’ plan to fix data integrity problems at its API manufacturing facility Taloja, India.

Sun buys stake in Russian API and drug firm JSC Biosintez

23-Nov-2016 - Sun Pharma has announced it will buy a controlling interest in Russian drug and API manufacturer JSC Biosintez to access local market.

Experts warn pharma to take precautions against Thanksgiving thefts

23-Nov-2016 - Holiday drug and API thefts are becoming less frequent but pharmaceutical firms still need to take precautions this Thanksgiving say experts.

US FDA calls Wockhardt efforts to fix Wrexham plant 'inadequate'

22-Nov-2016 - Efforts by Wockhardt to fix violations at drug plant in Wrexham, Wales are inadequate according to the US FDA which detailed its concerns in a warning letter this week.

US FDA asks Sekisui how it will fix API test data problems at Japan plant

21-Nov-2016 - The US FDA has asked Sekisui Medical to specify how it will resolve data integrity issues uncovered during an inspection of its API plant in Hachimantai, Japan in June.

US FDA asks Sekisui how it will fix API test data problems at Japan plant

21-Nov-2016 - The US FDA has asked Sekisui Medical to specify how it will resolve data integrity issues uncovered during an inspection of its API plant in Hachimantai, Japan in June.

Sanofi insulin buy back and rival price hikes a boon for MannKind's Afrezza

14-Nov-2016 - Despite requiring more API, the price of inhaled insulin Afrezza has dropped below that of injected rapid-acting rivals says MannKind's CEO, reporting a resilient Q3.

Precision meds and I-Phone microscopes: AAPS 2016 lands in Denver

14-Nov-2016 - AAPS 2016 kicked off yesterday with a focus on new technologies, new delivery modalities, accelerated drug development and precision medicines - oh and a microscope on an iPhone.

update

Keryx names Patheon as second Auryxia contractor

10-Nov-2016 - Keryx Biopharmaceuticals has hired Patheon to make the kidney disease drug Auryxia (ferric citrate) after its original contractor halted production.

News in brief

Wockhardt to up manufacturing capacity at Wrexham site

10-Nov-2016 - Wockhardt has said it will build a sterile manufacturing and drug testing facility at its site in Wrexham, Wales.

EAG opens elemental impurities lab citing US FDA alignment efforts

08-Nov-2016 - EAG Laboratories has set up an elemental impurities lab in response to US FDA moves to align testing rules with ICH Q3D guidance and USP requirements.

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