Breaking News on Global Pharmaceutical Technology & Manufacturing

Reinspection lands Alexion with 483 for Soliris plant

26-Aug-2014 - A US FDA reinspection of Alexion’s Rhode Island facility hit with a warning letter last year has resulted in a Form 483 with three observations.

USP joins campaign against illegal online pharmacies

26-Aug-2014 - Drug quality and standards organisation USP has joined a campaign to raise awareness about the risks posed by illegal online pharmacies.

Argentina to allow Indian drug imports after inspecting five plants

25-Aug-2014 - Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.

People on the Move

People on the Move at GSK, Allergan, Novartis

25-Aug-2014 - Our weekly round-up of the bright young things and big cheeses in pharmaceuticals.

UK drug exporters shipping outside the EEA must seek MHRA approval

20-Aug-2014 - EU law changes mean all UK firms handling pharmaceuticals for export outside the EEA must now be inspected and pay license fees according to the MHRA.

Eisai sues FDA for ‘losing one year’ of marketing to generics rivals

20-Aug-2014 - Eisai has accused the US FDA of unlawfully shortening market exclusivity periods for Belviq and Fycompa by starting the countdown one year before either was scheduled by the DEA.

India changes course, calls for bar codes for mono cartons in April

20-Aug-2014 - Nearly a month after India pushed back its deadline indefinitely  for exporters to put bar codes on their primary packages, the Directorate General of Foreign Trade  (DGFT) has set a new deadline of April 2015.

Frogs, fungus and falsified data - Indian firm falls foul of US FDA

20-Aug-2014 - Indian drugmaker Amanta has received a warning letter after the US FDA found evidence of data falsification and unsanitary conditions – including dead and decaying frogs next to a product exit dock – during an inspection last year.

Novo Nordisk defiant despite $90,000 disclosure fine

19-Aug-2014 - Novo Nordisk wants “a political debate” and changes to financial disclosure laws after Danish authorities fined it $90,000 for not immediately telling investors the US FDA had rejected Tresiba and Ryzodeg in 2013.

People on the Move

'Eye' spy changes at opthalmic firms

18-Aug-2014 -

Manufacturing issues cause recalls for Amgen, Baxter and Caraco

18-Aug-2014 - All three of the manufacturers announced recalls late last week either for potential contamination or cGMP (current good manufacturing practice) deviations.

Roche taps drug stockpile to aid China earthquake relief efforts

14-Aug-2014 - Roche has tapped into its antibiotic stockpile to aid Red Cross relief efforts in Yunnan, China which was struck by a major earthquake earlier this month.

ICH seeks bids to replace Northrop Grumman as MedDRA contractor

13-Aug-2014 - The ICH is looking for a new manager for its MedDRA international regulatory terminology standards system to replace current contractor, aerospace and defence technology giant Northrop Grumman.

Health Canada signs off on action plan for GSK flu vaccine plant

13-Aug-2014 - Bacterial contamination issues at a GlaxoSmithKline flu vaccine production plant are now being dealt with by an action plan that Health Canada has approved.

WHO: Data from use of unapproved Ebola drugs should be shared

12-Aug-2014 - Efficacy and safety data from use of unapproved Ebola virus treatments should be shared according to an expert panel convened by the World Health Organisation (WHO) this week.

GSK settles with US EPA over waste storage at US R&D site

12-Aug-2014 - GSK has stopped using an ethanol storage tank at a US R&D facility and agreed to pay a fine to settle US Environmental Protection Agency (EPA) allegations that it broke waste management laws. 

CMO issues persist as Cubist announces third recall for potential glass in antibiotic

11-Aug-2014 - For the third time since last August, Cubist Pharmaceuticals has recalled lots of its antibiotic Cubicin injection due to the potential of glass particulates in a manufacturing line produced by an unnamed CMO (contract manufacturing organization).

India’s CDSCO outlines procedures for state inspections of manufacturers

07-Aug-2014 - In order to ensure uniformity on the state and federal levels, India’s CDSCO (Central Drugs Standard Control Organization) has released seven procedural criteria for state drug inspectors to abide by.

Anti-addiction formulation rules on the way says drug abuse non-profit

06-Aug-2014 - The Center for Lawful Access and Abuse Deterrence (CLAAD) is working with the US Food and Drug Administration (FDA) on legislation for abuse-deterrent technology in opioids, its directors tell

News in brief

Impax hit with another US FDA Form 483

06-Aug-2014 - A week after receiving an FDA Form 483 for its Taiwan site , Impax Laboratories received another Form 483 for its Hayward, California site.

EMA concept paper focuses on quality control with animal tests

05-Aug-2014 - The European Medicines Agency (EMA) has issued a concept paper  on transferring quality control methods validated in collaborative trials that is intended to encourage the uptake of better tests in terms of the replacement, reduction and refinement of the use of animals in tests.

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.

UK says hidden drugs shortage ‘getting worse’ as generics supply slows

31-Jul-2014 - The UK All-Party Pharmacy Group (APPG) has warned Britain is suffering from a shortage of branded and generic drugs.

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.


Hikma buys Boehringer Ingeleheim CMO Ben Venue Labs

Ben Venue assets will bolster sterile injectables network, says Hikma

Hikma has bought defunct manufacturer Ben Venue and says it could reactivate the site in the long-term,...

Is your drug name ok? Run a role-play, says FDA

Is your drug name ok? Run a role-play, says FDA

Industry insiders have criticised new draft US Food and Drug Administration (FDA) guidance on choosing proprietary drug...

Generics: change in pill shape makes patients 66% more likely to quit

Generics: change in pill shape makes patients 66% more likely to quit

Switching patients to generic pills of a different shape and colour increases the chances they will end...

Eli Lilly swaps dry powder for insulin in Indianapolis restructure

Lilly swaps dry powders for insulin at Indiana site in post-patent shake-up

Patent expiration and a large molecule pipeline has prompted Eli Lilly to repurpose a solid oral dose...

Sterile injectables M&A could indicate return to in-house, says F&S

Sterile injectables M&A could indicate return to in-house production

Drugmakers are bringing sterile injectables capacity back in-house according to a Frost & Sullivan analyst, who says...

Glenmark to build first US manufacturing plant

Glenmark to build first US manufacturing plant

India-based Glenmark Pharmaceuticals has announced plans to set up a new oral solid dosage manufacturing facility in...

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