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Headlines > April 2016

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Uninvestigated complaints of APIs containing 'filth' land Polydrug with FDA warning

28-Apr-2016 - Indian firm Polydrug Laboratories failed to investigate complaints about APIs containing foreign bodies including hairs and insects, the US FDA says in a Warning Letter.

Aptar launches sensor counter tech for MDIs

28-Apr-2016 - Aptar Pharma has launched a new counter technology for metered dose inhalers (MDIs) it says can help enhance patient adherence.

Biotrinity 2016

UK fully supportive of complex pharma manufacturing, George Freeman MP

28-Apr-2016 - Precision pharmaceutical manufacturing is crucial to the UK’s economy, according to life science minister George Freeman MP.

Wuxi sets up drug supplier network to ease pharma sourcing

27-Apr-2016 - WuxI AppTec has a chemical trading network designed to help drug manufacturers source more efficiently.

Zurampic license will see AstraZeneca supply Ironwood

27-Apr-2016 - AstraZeneca will supply Ironwood Pharmaceuticals with the API and finished dosage form of the gout drug Zurampic under the licensing deal agreed this week.

Live from Interphex: VR, processing tech and manufacturing innovation

27-Apr-2016 -   [View the story "Live from Interphex 2016" on Storify]

Dispatches from Interphex

Fette Compacting unveils first capsule filling machine at Interphex

27-Apr-2016 - Fette Compacting has unveiled its first capsule filling machine, which is capable of outputting 400,000 capsules per hour – a new record in the industry.

Biotrinity 2016

Biopharma 'future is better in Europe,' says UK life science minister

27-Apr-2016 - Britain’s minister for life sciences has called on the country’s £60bn pharma sector to rally together in support of remaining in the European Union.

Controlled substances: fewer CMOs, more regulations

26-Apr-2016 - The manufacture of controlled substances has faced increased scrutiny over the years, and as such, fewer CMOs are in the market.

Almac Group launches new serialization solution

26-Apr-2016 - Almac Group has expanded its serialization capabilities to include its US commercial packaging facility in Audubon, PA.

3D printing can save drug manufacturers time and money says UK expert

26-Apr-2016 - 3D printing can make drug production simpler and cheaper according to a UK expert who says using it for commercial production is about “numbering up” not scaling up.

George Freeman: New meds and delivery methods a regulatory challenge

26-Apr-2016 -   [View the story "Live from #Biotrinity2016" on Storify]

Novartis aims to save $1bn by 2020 with integrated manufacturing plan

26-Apr-2016 - The savings will come from centralising manufacturing services and will complement the firm’s cost-saving business division launched last year.

Exclusive Q&A

Breaking barriers: Can continuous manufacturing prevail despite hurdles?

26-Apr-2016 - Regulations, recruitment and facility refits are holding continuous manufacturing back, but a Rutgers’ associate behind J&J’s recent success believes industry can overcome these hurdles.

WHO says Semler Research manipulated data and warns repeat studies may needed

25-Apr-2016 - The WHO has accused Semler Research of data fraud and said Mylan, Micro Labs, Lupin and Strides and others may need to repeat bioanalytical trials conducted by the CRO.

GSK's Ware Ellipta plant to supply US after Zebulon line operational

25-Apr-2016 - GSK has confirmed its new UK plant will continue to supply the US with Ellipta inhalers after capacity at its facility in North Carolina comes online this year.

Brexit bad for biosimilar developers says new industry group

22-Apr-2016 - Brexit would create regulatory uncertainty, delay the launch of biosimilars and prevent NHS cost savings according to the newly founded British Biosimilars Association (BBA).

Exco InTouch partners with Regulatory Strategies to meet data regulations

21-Apr-2016 - Exco InTouch has formed a strategic partnership with Regulatory Strategies, a data protection and compliance consultancy, in response to upcoming reforms.

GSK opens £56m Ellipta inhaler plant in the UK

21-Apr-2016 - GSK has doubled production capacity for its Ellipta dry powder inhaler (DPI) with a new UK manufacturing plant UK. 

Novo Nordisk €100m expansion to add 250 jobs in France

21-Apr-2016 - Novo Nordisk has announced plans to expand an insulin production site in France in the latest investment in its manufacturing network.

US FDA hits another Indian drugmaker over data integrity issues

21-Apr-2016 - Sri Krishna Pharmaceuticals has been hit with a warning letter after the US FDA found problems with quality data at a site in Hyderabad, India.

WHO removes TB and malaria drug APIs made by Anuh Pharma from approved list

21-Apr-2016 - The WHO has removed two APIs supplied by Anuh Pharma from its list of prequalified ingredients and announced plans to inspect the firm’s facility in Boisar, India.

'It was time' for dedicated polymer group, says PCI CEO

21-Apr-2016 - PCI Synthesis has formed a cGMP Advanced Polymer Development and Manufacturing Group after experiencing a growing demand from the industry.

Rutgers leading continuous manufacturing guidance efforts

J&J success will spur pharma's shift to continuous manufacturing, Rutgers

21-Apr-2016 - Industry will be encouraged to adopt continuous manufacturing methods following the regulatory success of Janssen’s Prezista, says Rutgers University associate director and Interphex speaker Doug Hausner.

update

US National Cancer Institute stops making cell therapy in light of contamination risk

20-Apr-2016 - Cell therapy and radiotracer production has halted at two facilities operated by the US National Institutes of Health (NIH) after consultants raised concerns about quality and manufacturing standards.

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