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APIs (active pharmaceutical ingredients)

News headlines

India cuts stability data reqs for API firms seeking docs to ship to EU

30-Oct-2014 - India has relaxed stability data requirements for API manufacturers seeking “written confirmation of quality” certificates needed to ship to the EU.

Novo Nordisk to hire 90 at newly acquired plant in New Hampshire

30-Oct-2014 - Novo Nordisk on Wednesday announced plans to hire up to 90 people at its newly-acquired manufacturing facility in West Lebanon, New Hampshire. 

EDQM sets new policy for testing of bacterial endotoxins

29-Oct-2014 - The European Directorate for the Quality of Medicines & Health Care, under the European Pharmacopeia, has set a new policy for the testing of bacterial endotoxins.

Pharma Action crude heparin plant due to open next week

28-Oct-2014 - A plant being set up by Pharma Action and meat supplier Toennies will produce 15 tonnes of 100% traceable crude heparin a year.

Superbug-driven surge in polymyxin demand prompts EMA to reassess safety info

27-Oct-2014 - A superbug-fuelled resurgence of polymyxin antibiotics has prompted the European Medicines Agency (EMA) to re-examine safety warnings for the side effect heavy anti-infectives

breaking news

Novo Nordisk subpoenaed over Danish manufacturing site

27-Oct-2014 - Novo Nordisk has been served with a subpoena over alleged manufacturing issues at its site in Kalundborg, Denmark.

Starting debate: EMA says rules on API materials need clarification

23-Oct-2014 - Drugmakers’ clashes with regulators over the suitability of API starting materials suggest ICH Q11 is open to interpretation and that clarification is needed according to the EMA.

Correction

Biotherapeutics need general chapters not individual Ph. Eur. monographs says EGA

21-Oct-2014 - Generic drugmakers want biotherapeutic products to have general recommendations in the European Pharmacopoeia rather than individual monographs.

News from CPHI Paris

Doctors ask for quick-dissolve meds to stop in-patient cheating

21-Oct-2014 - Patients receiving court-ordered treatment can be stopped from secretly spitting out their medicines by formulations which dissolve quickly in the mouth.

Deadly spider found in UK shopping could provide alternative to Viagra

21-Oct-2014 - Venom from a Brazilian Wandering Spider that ‘wandered’ into a UK household’s shopping basket could treat erectile dysfunction, according to scientists, in one example of drug ingredients being sourced from nature.

Quality probs and rising wages will see new API hubs replace China and India says analyst

20-Oct-2014 - Analysts predicting a second wave of global API hubs say it will be hard for manufacturers in Latin America, Ukraine and Taiwan to avoid the pitfalls that stymied former high growth sectors in Asia.

Canada issues licenses for critical drugs hit by Apotex/IPCA import alert

20-Oct-2014 - Over forty “necessary products” made at Apotex and IPCA facilities hit with an import alert can be sold in Canada after regulators took steps to prevent shortages.

Eli Lilly to sell PR plant due to patent expirations and shifting portfolio

20-Oct-2014 - Eli Lilly is set to close one of its Puerto Rican facilities as patent expirations and a shifting portfolio reduce its need for capacity.

News from cphi

Big Pharmas and API suppliers eyeing Brazilian Government deals says EMS

16-Oct-2014 - Government contracts guaranteeing market share in Brazil are starting to attract innovators like Roche, Novartis and Sanofi and may see API suppliers get long-term work according to a spokesman for Sao Bernardo do Campo-based drugmaker, EMS.

news from the edqm 50th anniversary conference

Food supplements are Europe's real counterfeit drug problem says AIFA expert

15-Oct-2014 - Drug active ingredients in food supplements are Europe’s real falsified medicines problem according to the head of AIFA’s counterfeit prevention team.

News from CPhI

Halal: accessing the untapped $30bn pharma market

13-Oct-2014 - The pharmaceutical industry must change its ingredients and manufacturing methods to cash in on the enormous purchasing power of European Muslims, says an expert.

Highly potent APIs: can lean manufacturing ever be safe?

09-Oct-2014 - The phrase “lean manufacturing” conjures up job cuts and not much more for many people, but managers can use the method to drastically simplify HPAPI (highly potent active pharmaceutical ingredients) production, says an expert.

Share API audits or see quality slump, says Hovione

08-Oct-2014 - The sharing of audit reports for active pharmaceutical ingredients (APIs) is essential in order to help avert the global decline in quality, according to Hovione’s CEO.

Dispatches from EDQM conference

EDQM set to fight fakes and forge closer ties with EMA

07-Oct-2014 - Counterfeit drugs and collaboration will be key topics for the EDQM say delegates at the organisation's 50th anniversary conference on Monday.

Lonza goes with the Flow Chemistry with latest API platform

07-Oct-2014 - Lonza has launched an API-making platform that uses chemical microreaction technology for continuous processing.

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