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News headlines

Fresenius: US supply from troubled Indian plant to restart in Q3

05-Aug-2014 - Fresenius Kabi has recommenced production at a troubled Indian facility and expects to start shipping APIs to the US in the next few weeks.

China's GMP drive will reduce API competition, says ScinoPharm

04-Aug-2014 - China has tightened its GMP requirements and compliant API suppliers will benefit from a reduction in competition, according to ScinoPharm.

Hospira's Rocky Mount 'returns to health' as reinspection cites no observations

31-Jul-2014 - Hospira has reached “a major milestone” in its remediation efforts at its troubled Rocky Mount plant following a US FDA inspection which resulted in zero observations.

Impax preparing response to FDA Form 483 with 10 observations

30-Jul-2014 - Impax Laboratories said it is working to address issues raised in an FDA Form 483 for its Taiwanese manufacturing facility, which was cited with 10 observations following an inspection in late July.

Chinese firm imported misbranded API into US, says FDA warning letter

30-Jul-2014 - Zhejiang Jiuzhou Pharmaceutical has received an FDA warning letter after shipping a misbranded active pharmaceutical ingredient to the US.

Biocon: Political turmoil hits sales, but quality systems ensure future

29-Jul-2014 - Robust quality systems differentiate Biocon from other Indian manufacturers, the firm says, despite political turmoil in the Middle East and North Africa impacting first quarter 2015 sales.

Ben Venue assets will bolster sterile injectables network, says Hikma

28-Jul-2014 - Hikma has bought defunct manufacturer Ben Venue and says it could reactivate the site in the long-term, despite the transfer of equipment across its sterile injectables network.

European Pharmacopoeia plans revisions of elemental impurities guideline

23-Jul-2014 - As the International Conference on Harmonisation (ICH) signs off on a new tripartite guideline related to elemental impurities, the European Pharmacopoeia Commission will revise its texts to ensure consistency. 

US FDA looks to increase cooperation with Latin American counterparts

21-Jul-2014 - The US FDA is looking to up its cooperative agreements with PAHO (Pan American Health Organization) as part of an effort that could bring as much as $10m over five years to the Latin American version of the WHO (World Health Organization).

Seizure treatment “special” recalled in UK after packaging problems

17-Jul-2014 - Three batches of the seizure drug midazolam made by UK CMO Penn Pharma are being recalled over concerns that packaging problems may affect its concentration.

India's CDSCO to pay people who report fake drugs

17-Jul-2014 - The CDSCO has accused international “vested interests” of labelling counterfeit drugs as “made in India” to damage the reputation of the country’s pharmaceutical industry and launched a scheme to reward people who report fakes.

Italian API manufacturer hit with FDA warning letter over data control

16-Jul-2014 - Cited with data quality issues, Italian API manufacturer Trifarma has until July 24 to respond to a litany of requests from the US FDA.

FDA proposed rule could delay import of excipients, PhRMA says

15-Jul-2014 - Although industry group PhRMA has called for the full implementation of a proposed rule that would allow the US FDA to destroy detained drugs deemed to be counterfeit or unapproved, the group also warns that such destruction could lead to manufacturing delays.

Waters to open laboratory with Chinese Pharmacopoeia

10-Jul-2014 - Pharma technology provider Waters as agreed with the Chinese Pharmacopoeia Commission (ChP) to establish a joint open laboratory to develop new pharmacopoeia standards.

Indian firms must invest in compliance as USFDA ups enforcement, says S&P

09-Jul-2014 - Indian drugmakers must invest heavily in compliance processes in response to the US FDA’s “aggressive surveillance” and inspection programme, a Standard & Poor report has said.

Apotex hit with warning letter on troubled API facility in India

09-Jul-2014 - Apotex is getting reprimanded once again for its API facility in Bangalore, India, after the company failed to adequately respond to an FDA Form 483 over data integrity issues, according to an FDA warning letter dated June 16 .

Merck Millipore says Indian lab can boost generics quality

07-Jul-2014 - Merck Millipore, the life sciences tools division of Merck KGaA, has launched a solid dose formulation lab in India, its first outside Europe.

News in brief

Sun Pharma pulls chemotherapy made at Gujarat plant

03-Jul-2014 - Indian drugmaker Sun Pharmaceutical has recalled 200 vials of the cancer drug gemcitabine in the US over concerns about its sterility.

B-MS recalls CMO made injectable blood thinner after finding "visible particles"

02-Jul-2014 - Bristol Myers Squibb (B-MS) has recalled several batches of the injectable version of the blood thinner Coumadin made by its CMO, Pharmalucence.

India delays bar codes for primary packaging indefinitely

30-Jun-2014 - With almost a week before Indian exporters would be required to put bar codes on their primary packages, the Directorate General of Foreign Trade (DGFT) in India has pushed back the deadline indefinitely.

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