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Headlines > March 2016

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Catalent softgel plant hit with US FDA 483 while client Opko receives CRL

31-Mar-2016 - The US FDA says it will not approve Opko's kidney disease drug Rayaldee until contract manufacturer Catalent fixes problems at its softgel plant in Florida.

Revised water for injection monograph allows use of cheaper and greener alternatives to distillation

31-Mar-2016 - The European Pharmacopeia Commission has adopted a revised monograph that allows a broader range of purification methods to be used for the production of water for injectable pharmaceuticals.

IMCD opens Japan office

31-Mar-2016 - IMCD has opened a sales office in Japan citing growing demand for pharmaceutical fine chemicals and food ingredients.

Cadila Healthcare confirms WHO notice of concern in BSE filing

30-Mar-2016 - Cadila Healthcare has confirmed receipt of a notice of concern (NOC) about its vaccine plant in Moraiya, India five months after the WHO inspectors criticized operations.

French regulators report GMP failings at Anuh Pharma API processing plant

30-Mar-2016 - Anuh Pharma has breached GMP rules at its API processing facility in Boisar, India say French regulators who visited the site last month.

AI solution redacts 'hundreds of studies per day,' Synchrogenix President

30-Mar-2016 - A new artificial intelligence-enabled solution redacts confidential information from clinical study reports with 99% accuracy in preparation for publication.

BioClinica expands eHealth leadership team

30-Mar-2016 - BioClinica is expanding its eHealth Solutions to support futher growth with the announcement two global executive-level additions.

India: PET OK in packaging, but phthalate excipient use should be minimized

30-Mar-2016 - There is no evidence PET (polyethylene terephthalate) packaging poses a threat to health but use of phthalate excipients should be minimized according to an Indian Government committee.

Capsugel ripe to be sold or go public, investment banker

30-Mar-2016 - Rumours Capsugel owner KKR is mulling a sale or an IPO fit with the typical private equity investment cycles says expert.

First 3D printed medicine now available

29-Mar-2016 - The drug, manufactured by Aprecia Pharmaceuticals, is the first 3D printed prescription drug to receive US FDA approval.

To affinity and beyond: Space age flow cytometry tech could aid cell therapy firms says LeukoDx

29-Mar-2016 - Know-how underpinning the tech astronauts use to detect infections in space could streamline cell therapy manufacturing according to new GE Healthcare partner LeukoDx.

Blu buy bolsters Puracap in US softgel market

29-Mar-2016 - Puracap has bought Blu Pharmaceuticals and its Puerto Rican manufacturing site and plans to double oral dose production capacity.

Facing further price cuts, Chinese companies look to diversification

29-Mar-2016 - China’s national development and reform committee (NDRC), which oversees pricing across industries, has announced plans to introduce further mandated price cuts.

Sanofi goes to High Court over Indian ban on fixed dose combo diabetes drug

24-Mar-2016 - Sanofi has challenged an Indian Government decision banning the manufacture and sale of its fixed dose combination diabetes drug, Amaryl MP.

Dipexium reports milestones in manufacturing of its antimicrobial peptide

24-Mar-2016 - Dipexium Pharmaceuticals has successfully scaled-up API for its antimicrobial peptide phase III candidate Locilex, made from the skin of the African Clawed Frog.

US FDA issues new labelling requirements for immediate-release opioids

24-Mar-2016 - The US FDA has ordered new labelling changes for immediate-release (IR) opioids but rejects claims that such products pose the same risks as extended-release (ER) opioids.

Siegfried and ROI: Swiss firm sees revs soar and says new API biz will drive growth

23-Mar-2016 - The Siegfried Group has reported record sales for fiscal 2015 and predicted the API business it bought from BASF will drive further growth this year.

Drug firms should share more data says environmental researcher

23-Mar-2016 - Drug companies should share more details of their APIs and the green credentials of the companies that supply says an award winning environmental researcher.

Hitachi Chemical licenses PCT tech and mulls cell therapy JV

23-Mar-2016 - Hitachi Chemical has licensed cell therapy manufacturing technology from PCT in a deal that may see the firms set up a European JV.

Meringue? No, you're not wrong: TxCell outlines unusual Ovasave delivery method

22-Mar-2016 - TxCell is working on new ways of delivering its Crohn's disease therapy Ovasave that will replace the somewhat unusual method it is using in clinical trials.

Lonza: More pharmas among top customers in 2015; Strong franc could erode Swiss industry

22-Mar-2016 - Drug companies were a more important source of revenue for Lonza in 2015 than in previous years with four of its five biggest spending customers coming from the pharmaceutical sector.

Braeburn plans $20m NC plant; awaits FDA decision on subdermal buprenorphine

22-Mar-2016 - Braeburn Pharmaceuticals will establish an R&D and manufacturing site in North Carolina for its subdermal implant candidate to treat opioid addiction.

Martindale removes povidone in oral methadone reformulation

21-Mar-2016 - Martindale Pharma will relaunch its opioid substitution therapy in Scandinavia after reformulating the oral solution to remove the excipient povidone.

Svizera: Premature WHO suspension notice at Indian plant 'hugely damaging'

21-Mar-2016 - The WHO has withdrawn a notice stripping Svizera Labs of prequalification status that it published in error last week.

Tesco and Waitrose supplier Marksans banned from shipping non-critical meds to UK

21-Mar-2016 - The UK MHRA has accused Marksans Pharma of destroying manufacturing records and banned the Goa, India firm from supplying “non-critical” drugs.

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