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

02-Dec-2016 - A ‘no’ vote in the referendum this weekend may hurt Italy’s API industry and impact European drug supply chains if it results in the country leaving the EU.

News in brief

Ecstasy to treat PTSD by 2021? US FDA approves Ph III trial

01-Dec-2016 - Party drug MDMA has been claimed to be effective in helping treat Post-traumatic stress disorder (PTSD) patients, with the FDA approval for a Ph III trial to go ahead in the US.

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.

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.

News in brief

Nitika to build 4th excipients plant near emerging Indian export hub

28-Nov-2016 - Nitika Pharmaceutical Specialties Pvt Ltd has said it will build a fourth pharmaceutical excipients plant in Nagpur, India.

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.

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.

MIT’s Langer sells off excipients biotech to break into Biosimilar market

21-Nov-2016 - Eagle Pharmaceuticals Inc. has announced its intention to buy Arsia Therapeutics citing its formulation viscosity reduction platform as the driver for the deal.

DISPATCHES FROM AAPS 2006

Excipient database: all systems go as US FDA clears backlog

16-Nov-2016 - The US FDA has almost cleared a backlog of 4000 excipient formulations in its Inactive Ingredient Database (IID) and wants drugmakers to help ensure ongoing accuracy.

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.

Biologics manufacturing services boost for Charles River Labs in Q3

04-Nov-2016 - Biologics manufacturing and testing activities helped Charles River Laboratories grow in Q3 and will drive further gains say analysts.

Wockhardt data may delay US solithromycin review says Cempra after asking Uquifa for CMC info

02-Nov-2016 - Cempra has asked Uquifa for API manufacturing data to support its US solithromycin efforts after raising concerns that information from Wockhardt in the current dossier will delay review.

Recipharm invests €1.2m in Italian small-scale API capabilities

02-Nov-2016 - Smaller drugmakers are shifting away from generics and towards niche new molecules says Recipharm, which has expanded a small-scale API facility to feed demand.

US FDA hits Chinese API maker with warning after having inspection impeded

02-Nov-2016 - Data integrity issues and the unexplained disappearance of drums of pharmaceutical ingredients have landed a Chinese API maker with a US FDA warning letter.

BASF upping cost of ethanolamines by €100 per tonne in Europe

31-Oct-2016 - BASF will increase the European sales prices for its ethanolamines by €100 ($110) per metric ton due to the rising costs of the raw material.

Lonza ups 2016 forecast citing Q3 biopharma gains; says capex will be higher

28-Oct-2016 - Lonza has raised its 2016 guidance and predicted higher spending on manufacturing equipment after growth of its biopharma businesses in the third quarter.

US FDA still worried about Interpharm's efforts to stop API data manipulation

26-Oct-2016 - The US FDA wants more information on Czech API firm Interpharm Praha AS’s efforts to prevent repetition of data manipulation uncovered during 2015 inspection.

Ashland opens Nanjing excipient plant citing growing local demand in light of new quality regulations

25-Oct-2016 - Ashland has opened a pharmaceutical excipients plant in Nanjing, China in a bid to capture growing local demand for modern formulation technologies.

Nitto Denko Avecia to buy Irvine and Avrio to expand offering

20-Oct-2016 - Nucleic acid manufacturer Nitto Denko Avecia has agreed to buy Irvine Pharmaceutical Services and Avrio Biopharmaceuticals in deals designed to expand its production business.

Merck completes expansion of Madrid Gonal-f API plant

19-Oct-2016 - Merck has completed the expansion of its biologics API manufacturing facility in Madrid, Spain increasing production capacity by 50%.

BASF halts production at Ludwigshafen plant after deadly explosion

18-Oct-2016 - BASF is confident the shutdown of its site in Ludwigshafen, Germany will not disrupt the supply of drug excipients.

WHO adds gatifloxacin to prequalification list to encourage API manufacturers

17-Oct-2016 - The WHO has added side-effect heavy, TB drug ingredient gatifloxacin to its prequalification list to encourage production.

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