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APIs (active pharmaceutical ingredients)

News headlines

API firm Unimark Remedies warned by US FDA about Indian plants

25-Aug-2016 - The US FDA has warned API manufacturer Unimark Remedies about unsanitary conditions at its facility in Vapi and Bavla in India.

CMO contracts will transfer to Pfizer

Pfizer to buy AstraZeneca's antibiotic business in deal worth up to $1.5bn

24-Aug-2016 - Pfizer will buy most of AstraZeneca’s antibiotics business in a $1.5bn (€1.32bn) deal that will see the Anglo-Swedish drug firm continue to package Merrem at its Macclesfield, UK plant for at least the next 18 months.

New synthesis promises to cut cost of making amine drugs

24-Aug-2016 - Scientists in Switzerland have developed a simple and cheap way to synthesise amines - compounds that form the backbone of many active pharmaceutical ingredients.

Phyton has developed a cell-based thapsigargin production method for Inspyr

23-Aug-2016 - Phyton Biotech has developed a cell based way of making thapsigargin, a cytotoxic plant extract that is being developed for the treatment of cancer by Inspyr Therapeutics.

BASF API biz boosts Siegfried in H1, but IT integration costs hit profits

22-Aug-2016 - Siegfried Holding AG has attributed a surge in API sales to the drug ingredients business it bought from BASF last year, but says that integration costs hurt profits.

US FDA wants to reclassify co-crystals to ease regulatory burden

18-Aug-2016 - The US FDA wants to reclassify pharmaceutical co-crystals as solvates rather than intermediates to reduce the regulatory burden on manufacturers that work with them.

Evolva to apply yeast-based production tech to APIs for US biotech partner

18-Aug-2016 - Evolva has agreed to develop new ways of making APIs for an unnamed US biotech using its fermentation system. 

Pfizer vancomycin supplier Zhejiang Medicine warned by US FDA

17-Aug-2016 - Pfizer supplier Zhejiang Medicine Co. should quiz staff to determine the extent of data integrity deficiencies at its API plant in Xinchang, China according to the US FDA.

Problem at UK API plant not Italian site says GSK

GSK API "issue" will limit supplies of Allergan's superbug buster Avycaz

17-Aug-2016 - An issue at a GSK API manufacturing site will limit supplies of the superbug busting antibiotic Avycaz for the next six months according to drug manufacturer Allergan.

Alcami plans to increase API production capacity

16-Aug-2016 - Alcami has announced plans to expand its facilities in Germantown, Wisconsin, in order to increase its Active Pharmaceutical Ingredient (API) production.

Statin APIs from Gedeon Richter-linked firm should be prohibited say GMP inspectors

16-Aug-2016 - German regulators want statin APIs made by Artemis Biotech to be banned after finding deviations good manufacturing practice (GMP) at the firm’s facility in Hyderabad, India.

AEMPS says Alcor's plan to fix problems at Spain plant is insufficient

15-Aug-2016 - Laboratorios Alcor SL's plan to fix problems at a manufacturing facility in Guadalajara, Spain is insufficient according to Spanish regulators.

SRF board approves new chloromethane plant to meet Indian pharma demand

11-Aug-2016 - SRF Limited has unveiled plans for a second chloromethane plant just two months after India imposed anti-dumping tariffs on Chinese and Russian imports. 

Agilent to up Oligo API capacity with new manufacturing plant

10-Aug-2016 - Agilent Technologies has announced plans for a nucleic acid API manufacturing plant in Colorado.

Pfizer halts production at Hospira India plant slammed by regulators

09-Aug-2016 - Pfizer has temporarily halted production at a former-Hospira aseptic plant in Chennai, India after regulators observed manufacturing issues during an inspection in June.

News in brief

Bangladesh Court orders 34 drug firms to halt production, again

08-Aug-2016 - The High Court in Bangladesh has ordered 34 firms to stop making drugs and recall products after discovering they had ignored a ban imposed in June.

Teva sees API sales surge in Q2

08-Aug-2016 - Teva Pharmaceutical Industries has reported higher second quarter API revenue citing a surge in demand from customers in the US and Europe.

Third strike for Wockhardt as API facility hit with US import alert

08-Aug-2016 - The US FDA has banned products from a third Indian manufacturing plant operated by Wockhardt.

WR Grace opens pharma-focused QC lab and predicts second half intemediates growth

08-Aug-2016 - W.R. Grace has opened a pharma quality control laboratory at its manufacturing facility in Albany, Oregon and predicted higher drug intermediates sales in the second half of the year.

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