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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.

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.

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.

European group responds to Indian proposal to replace gelatin in capsules

12-Apr-2016 - A European chemical industry group has reiterated that gelatin is safe after Indian regulators called for feedback on a plan to replace the excipient with cellulose in pharmaceutical capsules.

IPCA Laboratories will not supply anti malaria meds to the Global Fund

11-Apr-2016 - IPCA has lost its supply agreement with the Global Fund just weeks after claiming to have “written confirmation” of an impending order.

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.

India seeks input on proposal to replace gelatin with cellulose in capsules

11-Apr-2016 - Indian regulators have called for industry feedback on a proposal to replace gelatin in capsules with cellulose.

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.

Dispatches from DCAT Week

'Chindia' drug substance market not to be discounted

06-Apr-2016 - China and India are causing a “tsunami” in the drug substance market – yet significant hurdles may bring fine chemical outsourcing back to the West.

Daiichi Sankyo: looming Benicar patent loss and large molecule focus prompted plant closure

06-Apr-2016 - Closure of its Benicar intermediates plant was prompted by impending US patent loss and a decision to focus on large molecule drugs says Daiichi Sankyo.

Aesica adds dev-stage formulation capabilities for potent APIs and controlled drugs

05-Apr-2016 - Aesica has doubled early formulation development capacity and added controlled drug handling capabilities at its manufacturing facility in Queenborough, UK.

BASF extends excipient range with 'dust-free' coating alternative

04-Apr-2016 - BASF has expanded its Kollicoat range of polymer excipients with a product dust-free alternative to enteric coatings.

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.

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.

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.

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.

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.

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.

Targeting bacterial virulence not bugs could yield new meds say researchers

17-Mar-2016 - Compounds that leave pathogenic bacteria alive but harmless could yield antibiotics that are less likely to induce resistance development say the authors of a new study.

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