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Regulatory & Safety: Top Headlines

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.

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News in brief

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.

Regulatory & Safety: Featured news

Spotlight

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
UPDATE

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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