Breaking News on Global Pharmaceutical Technology & Manufacturing


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DSP: Pharmas must be open about API suppliers to fight antibiotic resistance

26-Sep-2016 - Drug companies need to me more open about their API suppliers to help fight the spread of antimicrobial resistance (AMR) according to DSM Sinochem Pharmaceuticals.

News in brief

Analytik Jena sets up joint application center

26-Sep-2016 - Analytik Jena and the Fresenius University of Applied Sciences are to create a joint application center for customers for teaching and research.

Urine derived clot busters do not pose Zika risk says EMA

22-Sep-2016 - Clot busting drugs derived from human urine are no more likely to be contaminated with Zika virus than other medicines according to research by the EMA.

Moderna to spend $110m on mRNA therapeutics manufacturing plant

21-Sep-2016 - Moderna Therapeutics has announced plans for a $110m (€98m) API manufacturing facility for its pipeline of mRNA therapeutics.

US FDA warns API firm Hebei Yuxing Bio-Engineering

21-Sep-2016 - Banned API firm Hebei Yuxing Bio-Engineering has had a microbial contamination problem at its plant since 2013 according to the US FDA.

Johnson Matthey's refurbished Annan API plant passes MHRA GMP inspection

20-Sep-2016 - The UK MHRA has awarded Johnson Matthey’s API facility in Scotland a GMP certificate.

Pii faces EU ban following GMP issues at Maryland facilities

19-Sep-2016 - The EMA has recommended a European ban of all non-critical drugs made by US CMO Pharmaceutics International Inc (Pii).

Bayer committed to pharma R&D and CapEx despite planned Monsanto buy

15-Sep-2016 - Bayer has said it will not cut drug R&D or manufacturing investment as a result of its planned acquisition of Monsanto.

Teva months from restarting production at Hungary plant banned by US FDA

15-Sep-2016 - Teva expects to restart drug manufacturing at the Hungarian plant under US import alert in the next few months.

Indoco Remedies stresses that Form 483s are not data integrity related

14-Sep-2016 - Indoco Remedies says problems the US FDA identified at an ophthalmic and injectable drug plant in Goa, India last month are “correctable.”

Novo Nordisk recalls GlucaGen HypoKit in US after error at syringe supplier

13-Sep-2016 - Novo Nordisk has recalled six lots of its GlucaGen HypoKit pen in the US after customers in Europe complained of detached needles.

India turns to certification in pharma manufacturing quality drive

01-Sep-2016 - India's government has launched a certification programme aimed at tightening up quality standards in its domestic drug industry.

'Chipped paint' and 'flying insects,' FDA slams two Chinese API plants

01-Sep-2016 - Xinxiang Tuoxin Biochemical has received a US FDA warning letter after manufacturing equipment at two API facilities were found to be in a state of disrepair.

Out-of-spec assay drove Teva to recall antibiotic from Canadian plant

31-Aug-2016 - An out-of-specification assay result resulted in Teva recalling over 50,000 bottles of the antibiotic amoxicillin made at a facility in Canada.

Quality issues at ex-Sun Pharma plant land Frontida with US FDA warning

29-Aug-2016 - The Pennsylvania plant released 27 lots of clonidine HCl tablets containing potentially contaminated active pharmaceutical ingredients (APIs), among several violations of cGMP the Agency said.

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.

Sagent recalls second lot of antibiotic made by Astral SteriTech after rust found in vial

23-Aug-2016 - Sagent Pharmaceuticals has recalled another lot of its injectable penicillin in the US after a customer found rust in a vial of the drug.

Cost pressures turning pharma towards automation tech, says Zenith

23-Aug-2016 - Increased cost pressures and a shift to biologics manufacturing are driving demand for automation technologies, says Zenith which is opening two offices in the US.

UK MHRA strips Pfizer-owned India antibiotics plant of GMP certificate

22-Aug-2016 - An Indian facility owned by Pfizer’s Hospira unit has been banned from supplying some drugs to the EU after MHRA inspectors found breaches of manufacturing regulations.

Actavis pulls Patheon-made diabetes pills after out-of-spec tests

22-Aug-2016 - Actavis has recalled five lots of a diabetes drug glipizide made by Patheon after tests revealed that the tablets did not meet specifications.

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