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APIs (active pharmaceutical ingredients)

News headlines

ScinoPharm showcases water treatment tech at Baxdela API plant

17-Aug-2017 - ScinoPharm has emphasised its compliance with waste water treatment rules, weeks after being contracted to supply API for Melinta Therapeutics’ antibiotic Baxdela.

GSK opens API facility in Scotland

16-Aug-2017 - GlaxoSmithKline has officially opened its aluminium salts facility in Montrose, Scotland.

EMA bids to clarify API starting material info pharmas should provide

16-Aug-2017 - The EMA has revised its reflection paper on API starting materials to clarify what information drug firms should provide about their starting materials under ICH Q11.

Wuxi AppTec says expanded STA will get drugs to market faster

14-Aug-2017 - Wuxi AppTec says merged development services and API business will provide customers with more integrated service. 

SK Capital will pay $110m for Perrigo's drug ingredients business

14-Aug-2017 - SK Capital has said it will buy Perrigo Company Plc’s drug ingredients business for $110m (€85m) in cash.

Avara agrees to buy ex-Hospira plant in Italy from Pfizer

10-Aug-2017 - Avara Pharmaceutical Services has agreed to buy Pfizer Inc. sterile drug manufacturing facility in Liscate, Italy.

Pfizer pulls lorazepam pills in Japan due to faulty engraving

10-Aug-2017 - Pfizer has recalled a batch of the antidepressant Wypax (lorazepam) in Japan after discovering faults with the engraving on some of the pills.

US FDA warns against PharmaTech LLC-made meds over B.cepacia risk

10-Aug-2017 - The US FDA has warned doctors not to use any liquid drugs made by PharmaTech LLC over renewed concerns they may be contaminated with the bacteria Burkholderia cepacia.

Japan tells Pfizer, Bayer, Daichi and others to expand drug warnings

08-Aug-2017 - The MHLW has ordered Pfizer, Bayer, Daichi Sankyo and firms selling generic warfarin and azithromycin in Japan to expand their products’ adverse event warnings.

update

Teva confirms API plant will be among 15 sites shut in cost cutting plan

07-Aug-2017 - Teva Pharmaceutical Industries Ltd has confirmed its API plant in Netanya, Israel will close as part of the cost reduction programme announced last week. 

Cambrex sees Q2 revs and earnings rise, confirms interest in takeovers

07-Aug-2017 - Cambrex Corporation says higher demand for APIs for controlled substances and branded drugs drove Q2 growth and confirms it is on the lookout for acquisitions. 

Lonza buys Micro-Macinazione to bolster micronization biz

07-Aug-2017 - Lonza Group AG has acquired API processing firm Micro-Macinazione SA from private equity investor Cross Equity SA.  

News in brief

Pfizer's API business revenue falls 13% on lower international sales

03-Aug-2017 - Revenue generated by Pfizer’s API and contracting business fell in the second quarter.

Scinopharm hired to make API for skin infection antibiotic Baxdela

03-Aug-2017 - Melinta Therapeutics has hired ScinoPharm to make the active pharmaceutical ingredient (API) for Baxdela, an antibiotic for skin infections that was recently approved by the US FDA.

Dr Reddy's saw API revenues slide in FY Q1 2018

02-Aug-2017 - Dr Reddy's says efforts to fix plant problems flagged by US FDA impacted its active pharmaceutical ingredient (API) business in the first quarter of fiscal 2018.

Fosun and KKR extend deadline for $1.2bn Gland Pharma deal

01-Aug-2017 - Shanghai Fosun Pharma and KKR have agreed to extended the termination date for the former's proposed $1.2bn (€1bn) takeover of Gland Pharma.

Lupin says it fixed issue flagged by US FDA during Aurangabad audit

01-Aug-2017 - Lupin says it has already resolved a problem flagged in a Form 483 issued by US FDA inspectors who visited its Aurangabad manufacturing facility in July. 

Merck & Co API operations hit by cyberattack yet to restart production

31-Jul-2017 - API operations hit by the Petya cyberattack have not been restored according to Merck & Co Inc, which expects difficulties fulfilling some product orders and lower 2017 profits partly due to the hack. 

Takeda licenses Zejula in deal that will see Tesaro supply it with API

31-Jul-2017 - Takeda has agreed to pay $100m (€85m) upfront for rights to make and sell to Tesaro Inc’s drug Zejula in Japan, South Korea, Taiwan, Russia and Australia.

Reig Jofre says it has resolved penicillin raw materials supply issue

27-Jul-2017 - Raw material supply problems that impacted its penicillin business last year have been resolved according to Reig Jofre.

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