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Headlines > All Ingredients News

Claris gets MHRA OK for injectables plant

21-Aug-2014 - Indian manufacturer Claris Lifesciences has had its injectable drug manufacturing facility in Ahmedabad approved by the UK MHRA.

Macfarlan Smith fined $12,000 after accident at API plant

21-Aug-2014 - Opiate API manufacturer Macfarlan Smith has been fined £12,000 for failing to ensure the safety of an employee injured at its plant in Scotland in 2011.

US FDA 'stamp of approval' testament to WuXi's growth in APIs

19-Aug-2014 - WuXiPharmaTech has received US FDA approval to manufacture an API for a commercial drug from a plant in Shanghai.

Recipharm to buy Corvette to drive Italian growth and boost freeze drying clout

19-Aug-2014 - Recipharm will buy Corvette Pharmaceutical Services Group from private equity owners LBO Italia Investimenti to add much needed lyophilisation capacity and increase access to the Italian market.

US mulls Federal Trade Zone status for Neolpharma Puerto Rico plant

18-Aug-2014 - US authorities are reviewing a Neolpharma request for tax breaks for APIs imported to a former Pfizer-owned plant it operates in Puerto Rico.

API sales down 81% as Ranbaxy feels fallout from US import alerts

14-Aug-2014 - Ranbaxy has reported a 14% drop year-on-year of overseas revenues attributed in part to the voluntary suspension of shipments from its Toansa and Dewas facilities API facilities.

Sanofi begins distribution of semi-synthetic antimalarials in Africa

14-Aug-2014 - Over the next few months Sanofi and non-profit PATH are delivering the first large-scale batches of an artemisinin-based combination therapy to five African countries, which will for the first time be manufactured with semi-synthetic artesunate.

Daiichi sells API plant and outlines business rejig

11-Aug-2014 - Daiichi Sankyo has agreed to sell a Japanese API plant to Alfresa Pharma as part of a wider reorganisation of its business.

News in brief

Ashland expands HPC production at VA plant

11-Aug-2014 - Fine chemicals manufacturer Ashland has laid down plans to expand a Klucel hydroxypropylcellulose (HPC) plant in Virginia to meet growing pharma demand.

THC may reduce tumor size? mouse study investigates

07-Aug-2014 - A previously unknown signaling platform may be responsible for the success of the main psychoactive ingredient in cannabis in reducing tumour size, which also may lead to the development of a synthetic THC equivalent, scientists say.

NIH toxicology contract renewed for MRIGlobal despite tightening budget

06-Aug-2014 - The tightening federal budget is increasing competition between research institutes and academia when it comes to preclinical toxicology testing, according to MRIGlobal.

News in brief

US, foreign API facilities to see FDA fees spike in 2015

05-Aug-2014 - US and foreign API facilities will see their annual US FDA facility fees rise more than $5,000, while their FDF (fixed-dose form) counterparts will see their fees rise by more than $20,000.

China's GMP drive will reduce API competition, says ScinoPharm

04-Aug-2014 - China has tightened its GMP requirements and compliant API suppliers will benefit from a reduction in competition, according to ScinoPharm.

Ireland looks to switch 12 APIs from prescription to OTC medicines

04-Aug-2014 - The Health Products Regulatory Authority (HPRA) of Ireland has published a list of 12 active substances contained in medicines that could potentially be switched from prescription-only to over the counter sale.  

Chinese firm imported misbranded API into US, says FDA warning letter

30-Jul-2014 - Zhejiang Jiuzhou Pharmaceutical has received an FDA warning letter after shipping a misbranded active pharmaceutical ingredient to the US.

Ipca halts API shipments to US following 483 at Indian plant

24-Jul-2014 - Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.

Onyx contracted for API R&D and manufacturing by UK cancer charity

23-Jul-2014 - Onyx Scientific has been contracted to develop and manufacture APIs for clinical trials by charitable group Cancer Research UK.

ADHD API sales up, specialty opiates down at Johnson Matthey in Q1

23-Jul-2014 - Johnson Matthey’s API business had a mixed fiscal Q1 with gains made in ADHD ingredients and bulk opiates being accompanied by a decline in revenue from specialty opiates.

European Pharmacopoeia plans revisions of elemental impurities guideline

23-Jul-2014 - As the International Conference on Harmonisation (ICH) signs off on a new tripartite guideline related to elemental impurities, the European Pharmacopoeia Commission will revise its texts to ensure consistency. 

New nanotech excipient offers cheaper solubility option say scientists

22-Jul-2014 - Scientists in Sweden have developed a magnesium carbonate-based excipient they claim is a low-cost nanotech alternative to silica for drugmakers struggling to formulate insoluble APIs.

Drug ingredients were key to Ireland's manufacturing growth in 2013 says CSO

21-Jul-2014 - Basic pharmaceuticals including APIs became even more important revenue generators for Ireland in 2013 according to new data released by the Central Statistics Office (CSO).

Janssen's tramadol supply chain ready for DEA's rescheduling deadline

16-Jul-2014 - Janssen Pharmaceuticals is prepared for Tramadol's reclassification by the US Drug Enforcement Administration (DEA) and says the supply of its versions of the opioid analgesic will not be interrupted.

FDA proposed rule could delay import of excipients, PhRMA says

15-Jul-2014 - Although industry group PhRMA has called for the full implementation of a proposed rule that would allow the US FDA to destroy detained drugs deemed to be counterfeit or unapproved, the group also warns that such destruction could lead to manufacturing delays.

Apotex hit with warning letter on troubled API facility in India

09-Jul-2014 - Apotex is getting reprimanded once again for its API facility in Bangalore, India, after the company failed to adequately respond to an FDA Form 483 over data integrity issues, according to an FDA warning letter dated June 16 .

Merck Millipore says Indian lab can boost generics quality

07-Jul-2014 - Merck Millipore, the life sciences tools division of Merck KGaA, has launched a solid dose formulation lab in India, its first outside Europe.

Spotlight

Hikma buys Boehringer Ingeleheim CMO Ben Venue Labs

Ben Venue assets will bolster sterile injectables network, says Hikma

Hikma has bought defunct manufacturer Ben Venue and says it could reactivate the site in the long-term,...

Is your drug name ok? Run a role-play, says FDA

Is your drug name ok? Run a role-play, says FDA

Industry insiders have criticised new draft US Food and Drug Administration (FDA) guidance on choosing proprietary drug...

Generics: change in pill shape makes patients 66% more likely to quit

Generics: change in pill shape makes patients 66% more likely to quit

Switching patients to generic pills of a different shape and colour increases the chances they will end...

Eli Lilly swaps dry powder for insulin in Indianapolis restructure

Lilly swaps dry powders for insulin at Indiana site in post-patent shake-up

Patent expiration and a large molecule pipeline has prompted Eli Lilly to repurpose a solid oral dose...

Sterile injectables M&A could indicate return to in-house, says F&S
UPDATE

Sterile injectables M&A could indicate return to in-house production

Drugmakers are bringing sterile injectables capacity back in-house according to a Frost & Sullivan analyst, who says...

Glenmark to build first US manufacturing plant

Glenmark to build first US manufacturing plant

India-based Glenmark Pharmaceuticals has announced plans to set up a new oral solid dosage manufacturing facility in...

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