Breaking News on Global Pharmaceutical Technology & Manufacturing

APIs (active pharmaceutical ingredients)

News headlines

Acquired Sigma-Aldrich businesses part of Merck's Africa growth plan

26-Nov-2015 - New acquisition Sigma Aldrich will play a part in African growth plans in addition to giving it a presence in the preclinical services sector says Merck*.

FDA warning for Sandoz after data and training issues at Indian plants

25-Nov-2015 - Manipulated employee records and English-only training materials were among violations cited by the US FDA at two Indian plants, but Sandoz is confident these will be resolved.

Ash Stevens to make API for Takeda's new oral blood cancer drug

24-Nov-2015 - The US FDA has cleared Ash Stevens to make the API for Takeda's new multiple myeloma drug Ninlaro, which is the first oral proteasome inhibitor to be approved in the country.

API sourcing leads US Gov to label Carlsbad's Acyclovir tablets as made in Asia

23-Nov-2015 - US Customs and Border Protection (CBP) says the country of origin of Carlsbad Technology’s acyclovir is where the API is sourced, not the US where the tablets are made.

Pharma unhappy with French 'made in EU' proposal

19-Nov-2015 - France's government has proposed new labelling for medicines that would indicate whether the contents were manufactured in or outside Europe.

Antibiotics: urgent calls for global payment pot

17-Nov-2015 - As World Antibiotics Awareness Week draws attention to the threat of resistance, pharma companies large and small say a worldwide overhaul of payment models will make anti-infective R&D profitable again.

Roche to exit four EU and US sites in small molecule network shake-up

16-Nov-2015 - Specialised drugs made using flexible technologies are the future for Roche’s small molecule portfolio, the firm says as it restructures its production network.

Government blames India's poor quality stigma on 'turf war' with West

09-Nov-2015 - The over-reaction to quality infringements by Indian drugmakers is part of a “turf war” with Western firms, the Indian Government says.

Three Dr Reddy’s sites hit with Warning Letters in India

09-Nov-2015 - Dr Reddy’s shares have slumped 14% after the company received an FDA Warning Letter over manufacturing conditions at three Indian sites.

News in brief

FDA warning letter for two Sandoz plants in India

03-Nov-2015 - The FDA last week issued a warning letter to Novartis following inspections of two Sandoz plants in India in 2014.

Graphene could strip polluting medicines from wastewater

29-Oct-2015 - Pollution caused by pharmaceuticals in wastewater is a major challenge facing the industry, but researchers in Greece may have come up with a solution.

Engineered banana protein shows potential as potent antiviral

28-Oct-2015 - A team of researchers has modified a lectin protein found in bananas to diminish its inflammatory properties, potentially setting it on the path to use as an antiviral.

Pharmerging markets will be a $500bn 'game changer,' says Reva

21-Oct-2015 - ‘Pharmerging markets’ have extended beyond Brazil, Russia, India and China (BRIC) and will be worth $500bn by 2020, according to Reva Pharma.

Pay-as-you-go or unlimited access? EMD ups its risk assessment service

20-Oct-2015 - EMD Millipore will offer drugmakers two-years of unlimited access to its suite of raw materials dossiers for 20,000€ as part of its enhanced portfolio offering.

Hovione to refurbish ex-generics plant for oral and inhalable formulation site

20-Oct-2015 - Hovione will spend $10m refurbishing a plant acquired from a Portuguese generics company to create an oral and inhalation formulation site.

Dispatches from CPhI

Around 80% of data integrity issues QC related, says CPhI expert

15-Oct-2015 - Increased efforts by the US FDA have made data integrity the hot topic on GMP compliance, according to a regulatory expert.

Dispatches from CPhI

EFCG: ‘API’ days for Europe as Big Pharma returns in search of quality

15-Oct-2015 - Big Pharma has returned to Europe for its API sourcing due to reasons of quality and reliability, according to the European Fine Chemicals Group (EFCG).

The self-regulation society? Consultant challenges manufacturing status quo

15-Oct-2015 - API suppliers should be allowed to make process improvements without having to seek re-approval says consultant Girish Malhotra, who argues that the current rules create inefficiency and waste.


Environmental protesters calling for for green APIs picket CPhI

14-Oct-2015 - Activists from Spanish NGO Ecologistas en Acción and global consumer watchdog SumOfUs disrupted proceedings at CPhI in Madrid today.

CPhI Worldwide 2015

As it happened: CPhI Pharma Awards winners announced

14-Oct-2015 -   [View the story "2015 CPhI Pharma Awards winners" on Storify]

Key Industry Events


Access all events listing

Our events, Shows & Conferences...

Product Innovation