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Acasti strengthens IP position for krill-derived rival to GSK's Lovaza

27-Apr-2017 - Acasti Pharma Inc. has been granted two additional composition and use patents for its investigational, hypertriglyceridemia drug candidate CaPre. 

DSM Sinochem to up capacity at Delft antibiotic intermediates plant

24-Apr-2017 - DSM Sinochem (DSP) has announced its intention to increase antibiotic production capacity at its facility in Delft, the Netherlands.

US ban for levonorgestrel supplier Qinhuangdao Zizhu raises WHO concerns

19-Apr-2017 - Discovery of data problems at Qinhuangdao Zizhu’s Hebei API plant indicates the firm did not follow a remediation plan agreed after a prequalification inspection in 2015 according to the WHO.


Teva confirms US FDA warning letter for Hangzhou, China API plant

18-Apr-2017 - Teva Pharmaceutical Industries says the US FDA has raised concerns about its API plant in Hangzhou, China.

DHL looks to strengthen presence in South American market

18-Apr-2017 - Deutsche Post DHL Group’s contract logistics business, DHL Supply Chain, has announced its intention to acquire Brazilian transport service provider Polar Transportes. 

Pork firm Smithfield sets up organ supply unit for regenerative meds sector

13-Apr-2017 - Smithfield Foods Inc. has tasked a new bioscience unit with turning byproducts from its pork business into supplies for regenerative meds and drug firms.

Teva's Austedo is first 'heavy hydrogen' drug to win US FDA approval

12-Apr-2017 - The US FDA has approved its first deuterated drug, clearing Teva’s Austedo (deutetrabenazine) for Huntington’s disease-related movement disorders.

Industry asks US FDA to "pause" data quality reporting plan

10-Apr-2017 - API, excipient and drug industry groups have reiterated concerns about the latest iteration of the US FDA’s “quality metrics” reporting requirements.

India cracks down on oxytocin makers to curb misuse in labour wards

06-Apr-2017 - India has told state regulators to inspect API sites making oxytocin in an effort to prevent the hormone being used to speed up childbirth without medical justification.

Strike ends at Pfizer plant after firm lets new staff join pension plan

06-Apr-2017 - Industrial action at a Pfizer Ireland Ltd plant in Ringaskiddy, County Cork has ended after the firm agreed to let 35 new staff to join the company pension scheme.

Medichem's solid dosage form plant approved by US FDA

06-Apr-2017 - A Combino Pharm dosage form plant in Malta has passed a US FDA inspection according to parent Medichem, which says it is now poised to expand its US business.

Alkem says US FDA has accepted plan to fix Ankaleshwar API plant

04-Apr-2017 - Alkem Laboratories Ltd says the US FDA has accepted its plan to bring its API plant in Ankaleshwar, India up to code.

Dr Reddy's says US FDA has issued Form 483 for Srikakulam API plant

04-Apr-2017 - The US FDA has completed its inspection of Dr Reddy’s API plant in Srikakulam, Andhra Pradesh and issued the firm with a Form 483 detailing two observations.

IATA OKs DHL air freight site for cold chain API and drug shipment

04-Apr-2017 - The International Air Transport Association (IATA) has certified a DHL air freight station in Leipzig, Germany for the cold storage and shipment of APIs and finished pharmaceuticals.

Shangpharma plans to merge API and research units and list in China

04-Apr-2017 - Shangpharma plans to merge its API unit with its research arm as Shanghai Chempartner, which it will list on the Shanghai or Shenzhen stock exchange.

Lonza confirms drug firm was biggest customer in 2016

31-Mar-2017 - Lonza's biopharma business grew faster than other divisions in 2016 with a drug firm becoming the Swiss life science supplier's biggest customer for the first time since 2013

Fresenius Kabi wants Wockhardt to amend Zosyn approval BSE filing

29-Mar-2017 - Fresenius Kabi wants Wockhardt to change a BSE filing it says does not accurately reflect its role in the production of a Zosyn generic recently approved in the US.

Divi's Labs' Vizag plant banned from shipping to US

23-Mar-2017 - Indian API firm Divi’s Laboratories has been banned from shipping drug ingredients made at its Vizag plant to the US.

US FDA says Jinan Jinda Pharma must do more make Shandong plant compliant

22-Mar-2017 - Jinan Jinda Pharmaceutical Chemistry Co. Ltd has more to do to bring its drug ingredient plant in Shandong, China up to code according to the US FDA.

Patheon ramping up former Roche site to fulfil demand for Western APIs

20-Mar-2017 - Patheon believes it can triple revenues at its recently acquired Roche facility in South Carolina due to a shortage of Western active pharmaceutical ingredient (API) capacity.

Cannabinoid-based chewing gum enrolls patients in Ph II trial

16-Mar-2017 - Axim Biotech has enrolled patients in its Phase II trial for Canchew Plus chewing gum – a delivery method with a “cumulative effect,” says CEO.

US FDA says Badrivishal can't ensure safety of river water used at API plant

16-Mar-2017 - The US FDA has criticised Badrivishal Chemicals & Pharmaceuticals for failing to document production and monitor the efficacy of water purification systems at its API plant in Maharashtra.  

Misbranded epilepsy drug API lands FDA warning for Chinese ingredient maker

15-Mar-2017 - The US FDA has slammed China’s Lumis Global Pharmaceuticals for problems documenting and labelling active pharmaceutical ingredients.

DSM Sinochem licenses enzymatic antibiotic production tech to Sandoz; sues Weiqida

15-Mar-2017 - DSM Sinochem Pharmaceuticals has licensed enzyme-based antibiotic production IP to Sandoz and accused Sinopharm Weiqida Pharmaceutical of patent infringement.

Siegfried’s revenues up on APIs and new plants, earnings down on costs

14-Mar-2017 - Siegfried saw higher sales in 2016 thanks to the API business it bought from BASF and opening of new plant in China, but profits fell on integration costs and higher taxes.

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