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APIs (active pharmaceutical ingredients)

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Catalent to increase spray-drying capacity for APIs at Pharmatek

27-Apr-2017 - Catalent Pharma Solutions has said it will increase spray drying capacity at a plant owned by recent acquisition Pharmatek Laboratories.

MPP to make hep C drug affordable for low and middle income countries

26-Apr-2017 - Pharco Pharmaceuticals has granted a license to make, sell and export the hepatitis C drug ravidasvir (RAV) to Medicines Patent Pool (MPP). 

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 FDA issues Sun with Form 483 after Dadra plant inspection

24-Apr-2017 - The US FDA has handed Sun Pharmaceutical Industries Ltd a Form 483 detailing critical observations made during an inspection of its Dadra, India facility.

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.

update

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.

Japanese drug production grew in 2015 according to new MHLW data

12-Apr-2017 - Domestic pharmaceutical production increased in Japan in 2015 according to data released by the MHLW.

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.

EMA sets up inbox for pharma whistle-blowers and adopts investigation policy

11-Apr-2017 - The EMA has set up an email inbox for drug company employees who report improper manufacturing and trial activities.

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.

China proposes changes to drug trial and API importation laws

03-Apr-2017 - Chinese regulators have proposed changes to rules covering clinical trials, API importation and drug approval in a bid to improve access to medicines.

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