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News headlines

US FDA warns opthalmic supplier Tubilux about Italian plant

19-Jul-2017 - The US FDA has called on Tubilux Pharma SPA to identify potential contamination sources at its eye medicine production plant in Italy in a warning letter this week.

Unorderly Brexit will cause UK drug shortages warn industry groups

17-Jul-2017 - UK patients face drug shortages unless Tory Government Ministers negotiate an orderly withdrawal from the EU – Brexit – that safeguards existing approvals and continued regulatory cooperation according to pharmaceutical industry groups.

GE Healthcare and Oritain launch testing service to combat serum fraud

12-Jul-2017 - Cell therapy firms will be able to authenticate the foetal bovie serum (FBS) they use through a testing programme launched by GE Healthcare and Oritain.

US FDA warns Vista Pharmaceuticals about Telangana plant

11-Jul-2017 - Vista Pharmaceuticals Limited’s plant in Nalgonda, Telangana is in a state of disrepair according to the US Food and Drug Administration (FDA).

Mylan's EU biosimilar ambition hit by GMP issues at Biocon plant

10-Jul-2017 - Three biosimilar products submitted to the EU for approval have suffered a setback after regulators found 35 GMP deficiencies at Biocon’s fill/finish facility in Bangalore, India.

update

Pacira to stop making DepoCyt due to long-term production problems

06-Jul-2017 - Pacira Pharmaceuticals Inc. has said it will stop making the cancer DepoCyt (cytarabine), citing persistent manufacturing problems.

US FDA slams Chinese heparin API testing facility with warning

05-Jul-2017 - Failure to establish system suitability testing for heparin and heparin-related drugs has landed Shandong Analysis and Test Center a US FDA warning letter.

Brazil tells Bayer to recall 13 lots of Gynera contraceptive

28-Jun-2017 - Anvisa has ordered Bayer to recall 13 lots of the contraceptive Gynera (gestodene + ethinyl estradiol) over concerns about stability data.

Fagron and Advanced Pharma pull drugs made at Pfizer's Rocky Mount site

27-Jun-2017 - Fagron Sterile Services and Advanced Pharma have recalled lots of injectable drugs made at Pfizer’s Rocky Mount facility in North Carolina.

US FDA rejects Pfizer's Epogen biosimilar citing McPherson site warning

23-Jun-2017 - Concerns about Pfizer’s fill/finish plant in McPherson, Kansas have prompted the US FDA to reject the firm’s biosimilar version of Amgen’s anaemia drug Epogen.

US FDA slams Chinese API maker over data breaches

22-Jun-2017 - Qinhuangdao Zizhu omitted, deleted and manipulated manufacturing data at its active pharmaceutical ingredient plant in Hebei, China according to the US FDA.

Corning life science focus: '21st century glass for 21st century drugs'

21-Jun-2017 - Corning says it is on the brink of capturing an increased share of the $12bn glass quality and packaging markets through material advancements in the space.

Pfizer recalls injectables made at Rocky Mount over potential contamination risk

19-Jun-2017 - Pfizer has recalled four injectables – including the already scarce heart surgery drug Sodium Bicarbonate - made at Hospira's facility in Rocky Mount, North Carolina after identifying a potential contamination risk.

Update with comment from MHRA

Europe tells API firms UK will be a “third country” like India and China after Brexit

15-Jun-2017 - The European Commission has confirmed that UK drug ingredient manufacturers will have to supply European customers with written confirmation their products are made in compliance with EU standards after Brexit.

update

AstraZeneca made Eliquis recalled in US says Bristol Myers-Squibb

15-Jun-2017 - Bristol Myers Squibb (B-MS) says the lot of Eliquis recalled in the US this week was made by AstraZeneca’s contract manufacturing business.

Update - BioMarin to hire 50 people at Shanbally

US FDA clears BioMarin to make $380,000-a year Vimizim in Ireland

12-Jun-2017 - The US FDA has cleared BioMarin Pharmaceutical Inc. to make the enzyme replacement drug Vimizim (elosulfase alfa) at its plant in Cork, Ireland.

News in brief

B-MS recalls US Eliquis Lot after low dose pills found in 5mg bottle

12-Jun-2017 - Bristol Myers Squibb (B-MS) has recalled one lot of the oral anti-clotting drug Eliquis in the US after a customer found 2.5mg strength tablets in a bottle labelled as containing 5mg tablets.

Q&A with the 'Medical Futurist'

'If only everyone's supply chain was as regulated and secure as pharma’s'

05-Jun-2017 - 3D printing, augmented reality and deep learning algorithms will shape the future of the pharmaceutical supply chain says Dr Bertalan Mesko, the Medical Futurist.

Visible particulates and leaking bags land B Braun Cali plant with FDA warning

31-May-2017 - The US FDA has slammed B. Braun Medical for repeatedly failing to thoroughly investigate quality concerns at a drugmaking facility in California.

Drug industry disaster concerns prompted lab expansion says Intertek

30-May-2017 - Drug industry concerns about natural disasters are driving demand for ‘storage-only’ stability testing according to Intertek, which has announced plans to expand its UK lab.

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