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CMOs need to increase awareness of offerings, ISR reports

20-Feb-2017 - A "new set of leaders" emerged in the contract manufacturing organization (CMO) industry over the past year, though many remain unheard of, according to a recent report .

Teva sees higher active pharmaceutical ingredient sales in 2016

15-Feb-2017 - Copaxone maker Teva Pharmaceutical Industries Ltd. saw higher active pharmaceutical ingredient (API) sales last year.

News in brief

Sun Pharmaceutical Industries sees API sales slide in Q3

15-Feb-2017 - Sun Pharmaceutical Industries Ltd. saw lower active pharmaceutical ingredient (API) revenue in the third quarter of fiscal 2017.

Stada confirms €3.5bn bid from Cinven and interest from Advent

14-Feb-2017 - API manufacturer Stada Arzeneimittel AG has received an acquisition offer from private equity firm Cinven Ltd., and an expression of interest from Advent International Corp.

Indian API maker slammed by US FDA for water and cleaning issues

14-Feb-2017 - The US FDA has issued a warning letter to Indian API maker Resonance Laboratories Private Limited citing inadequate cleaning procedures at its facility in Bangalore.

Pfizer to shut Australian Neulasta biosimilar plant and move production to Croatia

10-Feb-2017 - Pfizer will close the Australian plant which produces the API for HSP-130, a candidate version of Amgen’s Neulasta, and shift production to Croatia.

India to allow API firms to request EU quality confirmations online

09-Feb-2017 - Indian regulators will allow API firms to seek the confirmations needed to ship to the EU online from next month.

Pot luck? Medical marijuana's 'questionable quality’ no threat to pharma R&D

08-Feb-2017 - Pharma firms using cannabis-derived ingredients have hit out at the lack of standardization and the questionable quality of medical marijuana.

News in brief

Lannett injects $50m into Wyoming generic opioid build

07-Feb-2017 - Lannett Company, Inc. has announced it will invest $50m into its generic analgesic manufacturing subsidiary Cody Labs, creating 45 new jobs in the Wyoming facility.

Strides Shasun and Sequent to merge API units as standalone firm

07-Feb-2017 - Strides Shasun Ltd and Sequent Scientific Ltd have announced they will combine their API units into a standalone company.

Cambrex riding high on demand for Western innovator APIs

06-Feb-2017 - Limited US manufacturing capacity and a growing demand for innovator APIs will drive continued growth, says Cambrex.

Wuxi Apptec small molecule API subsid STA to hire more staff and expand

02-Feb-2017 - STA Pharmaceutical Co., Ltd. has announced it will hire approximately 100 additional R&D staff and expand its small molecule API and intermediates facility in Changzhou, China.

Chinese CDMO group buys New Jersey J-STAR for $26m

02-Feb-2017 - A US-subsidiary of the Chinese CDMO Porton Fine Chemicals Ltd. has bought the New Jersey based small molecule API contract research organisation, J-STAR Research, Inc. 

Mezzion hires Pol Pharma and Halo Pharma and accuses Dr Reddy's of fraud

01-Feb-2017 - Mezzion has hired Pol Pharma and Halo Pharma and accused former CMO Dr Reddy’s of hiding manufacturing problems that cost its erectile dysfunction candidate, udenafil, US approval.

US FDA calls CTX Lifesciences' plant remediation plan inadequate

01-Feb-2017 - The US FDA has asked CTX Lifesciences PVT Ltd for more details of how it will bring its API plant in India up to code.

Novartis unit Lek to expand Slovenian antibiotics plant

31-Jan-2017 - Sandoz subsidiary Lek will expand production capacity at its antibiotics facility in Prevalje, Slovenia.

Italy bans antibiotic APIs made by Antibioticos do Brasil

31-Jan-2017 - Italy has banned APIs made by Antibioticos do Brasil LTDA (ABL) at its facility in Bairro Itapavussu, Sao Paulo over sterility concerns.

Azelis lands nitroalkanes distribution deal with Angus Chemical

24-Jan-2017 - Angus Chemical Company has hired Azelis to distribute its nitroalkanes to pharmaceutical and biotech companies in Europe.

Sun declines to comment on New Jersey plant sale speculation

24-Jan-2017 - Sun Pharmaceutical Industries has declined to comment on reports it is to sell its US manufacturing business Ohm Laboratories.

Improving solubility: MilliporeSigma opens dedicated meglumine site

19-Jan-2017 - MilliporeSigma has opened a facility in Spain dedicated to the manufacture of the solubility-enhancing excipient meglumine.

Q&A with CEO and CMO

Medical marijuana chewing gum to treat IBS in Dutch trial

18-Jan-2017 - AXIM Biotechnologies, Inc. will start 40-person clinical trial in the Netherlands for a mint-flavoured medical marijuana chewing gum to treat Irritable bowel syndrome (IBS). 

US FDA slams Suzhou Pharmaceutical Technology for copy and paste CoAs

18-Jan-2017 - Suzhou Pharmaceutical Technology faked quality documents, shipped a banned supplier's API to the US and failed to store materials properly according to the US FDA. 

Aerie to build manufacturing facility in Ireland

11-Jan-2017 - Aerie Pharmaceuticals Inc will lease a 30,000 sq ft manufacturing facility in Ireland to commercialise its eye-drop product for Glaucoma after delays at a third party CMO.

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.

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.

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