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APIs (active pharmaceutical ingredients)

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NIPER says API nano crystal formulation tech will cut drug costs

02-Sep-2015 - The National Institute of Pharmaceutical Education and Research (NIPER ) in India has created and licensed technology for producing nano-crystal based medicines that it says will cut drug costs.  

The hunt for work after red October: Novo cites military experience as a big plus

02-Sep-2015 - Novo Nordisk says nuclear submarine veterans’ “mission critical” mentality is suited to pharmaceutical manufacturing environment.

Pfizer confirms it is evaluating Korea operations amid job cut rumours

02-Sep-2015 - Pfizer has confirmed it is in discussion with labour unions in Korea as part of an evaluation of its business in the country.

AMRI boosts opiate API biz through tech transfer and supply deal with Saneca

01-Sep-2015 - AMRI has inked a deal with Slovakia’s Saneca Pharmaceuticals to bolster its opium-derived API portfolio.

To supply the Dane: Novo expects First API batch in 2020

27-Aug-2015 - Novo Nordisk has confirmed it will build an API plant in the US, telling this publication a desire to have manufacturing capacity in the key market for its oral diabetes candidate, semaglutide, drove the decision.

DSM says plans to cut 1,100 jobs prompted by recent pharma moves not shareholder pressure

25-Aug-2015 - Royal DSM will make up to 1100 staff redundant by the end of 2017 to cut costs following the formation of its Sinochem JV and pharma products deal with Patheon.

‘Eat or be eaten;’ Mylan says Perrigo could be run as subsidiary

25-Aug-2015 - Mylan will run Perrigo as a wholly-owned subsidiary if it acquires between 50-80% of shares, the firm has clarified.

News in brief

CMO Regis Technologies opens potent API site

25-Aug-2015 - Regis Technologies has opened a site for manufacturing highly potent active pharmaceutical ingredients (HPAPIs) in Illinois.

News in brief

AmbioPharma expands US manufacturing site and starts work on global HQ

24-Aug-2015 - Peptide maker AmbioPharma will invest $18.8m to expand its manufacturing operations in South Carolina in a move that it claims will create 100 jobs.

Valeant to buy "female viagra" maker Sprout for $1bn

20-Aug-2015 - Valeant Pharmaceuticals is set to buy Addyi maker Sprout Pharmaceuticals under a $1bn (€895m) deal agreed today.

Xellia moves US HQ to North Carolina

20-Aug-2015 - Anti-infectives firm Xellia has moved its North American HQ to the lyophilisation plant in Raleigh, North Carolina that it bought from Fresenius Kabi last July .

Italy bans 7 APIs from compounding pharmacies after off-label abuse

20-Aug-2015 - The Italian Ministry of Health has banned compounding pharmacies from preparing drugs containing any of seven APIs after chemists were discovered making dangerous off-label weight loss treatments.

Pharma plants strike in Pakistan to protest QC rule changes

19-Aug-2015 - Pakistani pharmaceutical manufacturers are today halting production in protest at changes to manufacturing regulations.

Three Mylan plants in India hit with FDA warning letter

19-Aug-2015 - As it tries to close its biggest deal ever -- a $33bn acquisition of Perrigo -- Mylan is now also dealing with an FDA warning letter citing cGMP violations tied to three of its manufacturing facilities in India.

Laser synthesis technique could provide better APIs

12-Aug-2015 - Scientists in Japan have developed a technique for making crystal forms of active pharmaceutical ingredients (APIs) that until now have been hard to synthesise.

Next-gen APIs will exploit ‘bugs’ in human gut

11-Aug-2015 - Small molecules from our gut microbes are providing the APIs for future drugs. 

FDA veteran questions science behind antibiotics fast track

03-Aug-2015 - As the US regulator awards iclaprim expedited QIDP status, a former FDA antibiotics expert says the scheme boosts antibiotics without enough evidence for efficacy.

Echo's cannabis API delivery formulation could aid low solubility drugs

30-Jul-2015 - A drug delivery platform which increased the bioavailability of a cannabis-based drug candidate 30% could be used to boost solubility of other APIs, says Echo Pharmaceuticals.

'Rough notes' and backdated signatures land Indian API maker US FDA warning

29-Jul-2015 - Issues with batch production records at an Indian facility have landed API maker Mahendra Chemicals with a US FDA warning letter.

FDA offers draft guidance on quality metrics used to assess drug manufacturing

29-Jul-2015 - New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes that they use to make drugs and biologics.

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