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APIs (active pharmaceutical ingredients)

News headlines

AMRI acquires API business, expands into Europe

05-May-2016 - AMRI has acquired the Italy-based chemical company, Euticals, in a move that expands its API development and manufacturing business.

update

EDQM: Harmonized generic drug reviews would help regulators, pharmas and patients

03-May-2016 - Increased use of generics has put pressure on drug reviewers according to the EDQM which has called for more cross border collaboration and harmonization of regulations.

Codexis completes transfer of protein engineering tech to US GSK site

03-May-2016 - Codexis has completed the transfer of its protein engineering platform to a GSK earning it a $7.5m milestone payment.

Cambrex: delayed API plant opening set for Q2 opening

02-May-2016 - An API facility Cambrex is setting up in Charles City, Iowa will be operational later than planned due to delayed equipment deliveries and installation challenges.

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.

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.

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.

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.

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.

PCI Synthesis sets up polymers development lab

20-Apr-2016 - API manufacturer PCI Synthesis has set up a polymer development group citing growing drug industry demand for advanced coating technologies and excipient technologies.

Johnson Matthey and Domainex team on API discovery and development

19-Apr-2016 - Johnson Matthey has teamed up with Domainex to offer integrated API discovery, preclinical development and manufacturing services. 

Evotec has been contracted to manage candidate APIs by Pierre Fabre

19-Apr-2016 - Evotec has been hired to manage candidate drug compounds by French privately-owned pharmaceutical firm Pierre Fabre.

Recipharm to buy Kemwell's API and formulations business for SEK1.7bn

18-Apr-2016 - Recipharm has agreed to buy Kemwell’s contract development and manufacturing business for a total of SEK1.7bn in two separate deals.

US FDA guidance looks to stem ‘major problem’ of data integrity

18-Apr-2016 - The US FDA has issued draft guidance to address the recent torrent of data integrity problems at drug manufacturing sites.

Lonza would add drug delivery tech through Catalent merger, analyst

14-Apr-2016 - Lonza acquiring Catalent would make “strategic sense,” according to an analyst as rumours circulate about a CMO megamerger.

News in brief

Orchid Pharma antibiotic API plant passes US FDA inspection

11-Apr-2016 - API firm Orchid Pharma has passed a US Food and Drug Administration (FDA) inspection at its facility in Tamil Nadu, India.

Gilead antiviral API supplier expanding plant after US FDA OKs Descovy

07-Apr-2016 - Pharmachem Technologies has started expanding its API facility in Grand Bahama just days after its main customer Gilead Sciences won US FDA approval for a new HIV drug.

Sun's so-long wave to Tipperary: Indian firm to close Ranbaxy plant this year

07-Apr-2016 - Sun Pharmaceuticals has confirmed it will close a Ranbaxy Laboratories facility in Ireland by the end of the year.

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