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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.

Pharma pollution an 'ignored' cause of antibiotic resistance

24-Aug-2016 - Pollution in pharma supply chains is contributing to the spread of antimicrobial resistance (AMR), says a new report.

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.

Piramal: $53m Ash Stevens addition ‘synergistic’ with ADC business

18-Aug-2016 - The acquisition of Ash Stevens and a US high potent API facility will bolster Piramal’s antibody-drug conjugate offerings, the Indian CDMO says.

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.

Lonza acquires InterHealth for $300m

15-Aug-2016 - Lonza has announced its plans to acquire Benicia, CA-based InterHealth Nutraceuticals, a nutritional ingredient research, development, and manufacture company.

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.

IMCD completes Mutchler takeover to access the US pharma excipients market

09-Aug-2016 - IMCD has entered the US pharmaceutical market with the acquisition of specialty API and excipient distributor Mutchler.

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.

AMRI's API revs up in Q2 after Gadea offsets plant closure and lower royalties

04-Aug-2016 - Steroid API firm Gadea Pharmaceuticals helped AMRI grow revenue in the second quarter offsetting flat royalties and the impact of the closure of its site in Holywell, Wales.

US FDA says Xiamen Origin Biotech lied to inspectors who visited API plant

03-Aug-2016 - The US FDA says Xiamen Origin Biotech Co. lied to investigators during an inspection of its API facility in Fujian in which significant deviations from cGMP were identified.

News in brief

Biesterfield buys fellow API distributor Schütz

02-Aug-2016 - Biesterfeld says the acquisition of fellow Germany-based distributor Schütz strengthens the firm’s focus on specialty chemicals.


Spanish regulators: Jinan Jinda Pharmaceutical Chemi should not supply nitrofurantoin to EU

02-Aug-2016 - Jinan Jinda Pharmaceutical Chemi has not fixed GMP deficiencies at its Shandong plant say Spanish regulators calling for ban on nitrofurantoin shipments to the EU.

Hemispherx hires Avrio as Ampligen CMO while it tries to win US approval

01-Aug-2016 - Hemispherx Biopharma has hired Avrio Biopharmaceuticals to make Ampligen while it continues to try and win US approval for rejected candidate chronic fatigue syndrome (CFS) drug candidate.

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