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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.

GSK confident despite ongoing endotoxin problems at Canadian flu vaccine plant

25-Jun-2014 - GSK is confident it can meet Flulaval production targets ahead of this winter’s flu season despite ongoing endotoxin contamination problems at a Canadian plant hit with US FDA warning letter. 

SAFC to make virus-resistant cell lines

24-Jun-2014 - BioReliance and its parent company SAFC say they are working on viral-resistant cell lines that will prevent contamination in bioreactors.

Copley develops new testing techs for generic respiratory drugs

24-Jun-2014 - Copley Scientific has launched new technologies to help developers of generic inhalable drugs stick to specific testing guidelines issued by the US FDA and USP. 

Big Pharma Insourcing replacing Asian suppliers as competition for western CMOs

23-Jun-2014 - Hidden costs and quality issues have encouraged pharma to abandon China and India, but Western CMOs are now under threat from a return to in-house manufacture, says a procurement consultant

Hospira recalls Marcaine anaesthetic after vial contamination

23-Jun-2014 - Hospira has recalled a batch of its anaesthetic Marcaine due to visible fragments in the vials.

Arecor and CPI team on biologics stability research project

17-Jun-2014 - Formulations that stop biopharmaceuticals being degraded by vials and syringes could help biopharmas avoid recalls and improve product shelf life says the UK team behind an industry focused research collaboration.

Doubts over CDSCO claim it can assess an API supplier in 30 days

12-Jun-2014 - A European expert has cast doubt on a claim by Indian regulator CDSCO that it can assess and confirm the quality of an API supplier’s manufacturing operations in writing in just 30 days.

US FDA offers new supply chain security guidance

12-Jun-2014 - As manufacturers will have to identify illegitimate product for trading partners and the US FDA beginning next year, the agency is now offering pragmatic advice in the form of draft guidance for drugmakers regarding situations where suspect product might enter the supply chain.

Fight the Fakes campaign adds bevy of new partners

11-Jun-2014 - The advocacy campaign to raise awareness about falsified and fake drugs has added 11 new partners to its cause, including US-based GPhA (Generic Pharmaceutical Association).

Rx-360 pushes into China with new working group

11-Jun-2014 - Supply chain security consortium Rx-360 has shifted its focus to China where it is forming a working group to further ensure compliance in a country that has had some difficulties with spurious drugs in the past.

Wockhardt’s Illinois manufacturing facility hit with FDA Form 483

04-Jun-2014 - The Form 483 from the US FDA cited Chicago-based Morton Grove Pharmaceuticals, which was acquired by Wockhardt in October 2007, for 12 different observations.

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