Breaking News on Global Pharmaceutical Technology & Manufacturing

APIs (active pharmaceutical ingredients)

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Sandoz teams with delivery tech firm MedinCell to get under the skin of cancer

04-Feb-2016 - Novartis subsidiary Sandoz will commercialise small and large molecule injectables using French delivery tech firm MedinCell’s subcutaneous controlled release platform.

Increased scrutiny requires digging deeper into the supply chain

04-Feb-2016 - As threats to the pharmaceutical supply chain prevail, the industry is seeing increased regulatory scrutiny as well as more inspection requirements, says industry panel.

Made in China: Envirotainer teams with drug and API shipper Air China Cargo

03-Feb-2016 - Envirotainer has partnered with Air China Cargo in deal that will see local and international drug and API makers use its range of cold chain shipping containers.

Teva upskilling of UK sterile site could lead to loss of 80 jobs

03-Feb-2016 - Up to 80 UK sterile manufacturing jobs could be lost as part of a technical overhaul at a Teva site near Liverpool.

Indonesia mulls foreign JVs and reduction on imports to boost local API production

02-Feb-2016 - Incoming Indonesian government measures to attract foreign manufacturing joint ventures (JVs) could include a regulation to reduce API imports, Vincent Harijanto, committee head GP Farmasia said.

Novasep expands API lab to grow US sales after Pharmachem divestiture

02-Feb-2016 - Novasep has announced it is expanding API synthesis its facility in Boothwyn, Pennsylvania and confirmed that US growth is important after the sale of Pharmachem.

Surging demand for APIs prompts expansion of second Onyx facility

01-Feb-2016 - Onyx Scientific will add a 6250sq ft facility at its site in North-East England to cope with a surge in demand for its small-scale API services.

Ipca not surprised by US FDA warning at three Indian API plants

01-Feb-2016 - Ipca has received an FDA Warning Letter at three Indian API facilities, but says it awaits re-inspection after already rectifying issues highlighted in a 2014 Form 483.

Regulatory reforms to reshape drug manufacturing in China says expert

28-Jan-2016 - More plants in China will close says a US-based analyst who predicts that some drugmakers' inability to comply with stricter quality rules will create an opportunity for those that can.

Increased US FDA oversight driving recent China plant warnings

27-Jan-2016 - The recent tide of Warning Letters issued to Chinese API and finished formulation makers reflects an increase in regulatory oversight, the US FDA says.

Hermes adapts food coating technique for API taste masking

26-Jan-2016 - Hermes Pharma has added hot melt coating capabilities to its offering and hopes the food industry technique will win it pharma customers with unpleasant tasting APIs.

Johnson Matthey expands Cambridge catalysis facility

21-Jan-2016 - Johnson Matthey has expanded its UK biocatalysis R&D operations in response to growing drug industry demand.

US NIAID awards $5m to researchers developing non-traditional therapeutics for bacterial infections

20-Jan-2016 - $5m in funding has been awarded to various research projects in order to help develop non-traditional therapeutics for bacterial infections.

US FDA and French regs hit separate Chinese API makers with warnings

14-Jan-2016 - Systemic data manipulation has landed Chinese API maker Zhejiang Hisun Pharmaceutical with a US FDA warning letter.

‘Unshackled’ from Sanofi, MannKind turns to Technosphere and Twitter

14-Jan-2016 - MannKind says its Technosphere delivery platform could yield short-term cash and drive long-term growth.


Better data can encourage industry to trial generics for new indications

13-Jan-2016 - Higher quality data could convince pharma firms to pay to trial generic drugs for new indications say researchers calling for diclofenac to be studied as a cancer treatment.

Down but not out: MannKind sees positive in Sanofi’s Afrezza exit

06-Jan-2016 - Sanofi has abandoned Afrezza less than a year after its launch, but the future of the inhaled insulin product is secure according to developer MannKind.

Zydus Cadila Indian plants hit by US FDA warning letter

04-Jan-2016 - Cadila Healthcare has received a US FDA warning letter citing GMP deviations at an API plant and a formulation facility in Ahmedabad, India.

Martin Shkreli charged with securities fraud

18-Dec-2015 - ‘Twas the week before Christmas, and what do you know?

More systems training needed to help inspectors spot data falsification say PIC/S experts

16-Dec-2015 - Data falsification at API facilities is getting harder to spot say regulators who have called for more systems training and international collaboration.

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