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APIs (active pharmaceutical ingredients)

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Trump vows to bring drug production back to US

12-Jan-2017 - President elect Donald Trump has said he will bring drug manufacturing back to the US and introduce bidding measures to cut the amount the country spends on medicines. 

Novo Nordisk hires Fluor to build giant US diabetes drug API plant

10-Jan-2017 - Novo Nordisk has hired Fluor Corporation to design and build the diabetes drug API plant it is setting up in Clayton, North Carolina.

US DEA finalises controlled substance and equipment revisions

09-Jan-2017 - Drugmakers must include a transaction identification number when buying or selling machinery for tabletting or encapsulating controlled substances, according to a final ruling from the US DEA.

Patented biosynthesis produces 'authentic, standardized cannabinoids' for pharma

05-Jan-2017 - Teewinot’s Irish subsidiary has been granted a fourth patent for a pharmaceutical cannabinoid manufacturing technique which it says saves both time and money.

Out with the old, in with the new? Lonza sells peptide biz, Recipharm adds Indian ops

05-Jan-2017 - Recipharm receives approval to buy Kemwell’s Indian operations and PolyPeptides completes the acquisition of Lonza’s peptide business. Welcome to in-Pharmatechnologist’s 2017 M&A round-up.

Data integrity and aseptic issues land Wockhardt with FDA warning

04-Jan-2017 - A Wockhardt facility in India put under import alert last year has received a US FDA warning letter citing issues ranging from data discrepancies to inappropriate aseptic clothing.

Fire at Sun Pharma API factory kills two

04-Jan-2017 - Late last week, a fire at Sun Pharmaceutical Industries Limited’s Ahmednagar factory, which manufactures APIs, sent four employees to the hospital.

Lonza contracted to make API for Aurinia's lupus nephritis candidate

21-Dec-2016 - Lonza has been contracted to the API for a candidate lupus nephritis treatment by Canadian developer Aurinia Pharmaceuticals Inc. 

Lonza contracted to make API for Aurinia's lupus nephritis candidate

21-Dec-2016 - Lonza has been contracted to the API for a candidate lupus nephritis treatment by Canadian developer Aurinia Pharmaceuticals Inc. 

US FDA has concerns about Granules - Ajinomoto OmniChem's Vizag API plant

20-Dec-2016 - US FDA inspectors have raised questions about an API manufacturing facility in India that is operated by Granules India and Ajinomoto OmniChem.

Cipla to make drugs in Iran in deal with Ahran Tejarat

15-Dec-2016 - Cipla Ltd has formed a joint venture with Ahran Tejarat Company to manufacture and sell drugs in Iran.

Update

Syngene's Bengaluru site damaged by fire

13-Dec-2016 - A fire has damaged a facility operated by Indian contractor, Syngene International. 

Saneca gets Gov grant to invest in API plant

13-Dec-2016 - The Slovakian Government has granted Saneca Pharma €1.5m ($1.6m) to invest in ‘green’ API manufacturing and anti-abuse technologies for its opiate-based drugs.  

A Roche of la Grippe: India’s Natco and Alvogen launch Tamiflu generic in US

13-Dec-2016 - Natco Pharma and partner Alvogen have launched the “first generic equivalent” of Roche’s Tamiflu (oseltamivir phosphate) in the US.

News in brief

Alkem issued with Form 483 by US FDA

12-Dec-2016 - The US FDA has issued Indian API firm Alkem Laboratories Ltd. with a Form 483 after an inspection at is site in Ankleshwar, Gujarat.

Catalent joins industry group supply chain initiative

12-Dec-2016 - Catalent has become the first CDMO to join the PSCI – a voluntary industry initiative focused on the social, environmental and economic impact of the supply chain.

WHO commits to source drugs and vaccines from 'green' suppliers

09-Dec-2016 - The WHO has agreed to source drugs from manufacturers which use sustainable production methods.

Mylan says cost cutting plan will impact up to 10% of its staff

07-Dec-2016 - Mylan NV has announced a restructuring plan that it says will impact less than 10% of its workforce.

Lonza to sell therapeutic peptides business to PolyPeptide

07-Dec-2016 - Lonza has agreed to sell its therapeutic peptide business to PolyPeptide Laboratories in a deal that will also see the latter firm take on 280 staff.

US FDA says Interquim's API plant remediation plan is inadequate

06-Dec-2016 - The US FDA has asked Spanish API firm Interquim S.A. for more details of its plan to bring its Barcelona manufacturing plant up to code.

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