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APIs (active pharmaceutical ingredients)

News headlines

Compounding the problem: US warns two more pharmacies

01-Sep-2014 - The US FDA has criticised the Compounding Shop and Zion Rx Formulations Services for making unapproved and contaminated drugs.

Merck KGaA biopharma division to make small molecule drugs in China

29-Aug-2014 - Biopharmaceutical firm Merck Serono will make small molecule drugs at the new plant it is building in China according to a company spokeswoman, who told us the firm will supply both local and international markets.

GSK: GM yeast breakthrough won't kill off poppy-based opium

28-Aug-2014 - Poppies will continue to be the main source of industrial opiates long-term according to GSK, despite a recent breakthrough in efforts to produce it in GM yeast.

EMD Millipore to supply Samsung's Yervoy plant in 10-year deal

26-Aug-2014 - EMD Millipore has been contracted to supply raw materials to the Samsung Biologics plant where ingredients for BM-S’ anticancer monoclonal antibody Yervoy (ipilimumab) are made.

Argentina to allow Indian drug imports after inspecting five plants

25-Aug-2014 - Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.

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.

Manufacturing issues cause recalls for Amgen, Baxter and Caraco

18-Aug-2014 - All three of the manufacturers announced recalls late last week either for potential contamination or cGMP (current good manufacturing practice) deviations.

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.

Anti-addiction formulation rules on the way says drug abuse non-profit

06-Aug-2014 - The Center for Lawful Access and Abuse Deterrence (CLAAD) is working with the US Food and Drug Administration (FDA) on legislation for abuse-deterrent technology in opioids, its directors tell in-PharmaTechnologist.com.

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.

Fresenius: US supply from troubled Indian plant to restart in Q3

05-Aug-2014 - Fresenius Kabi has recommenced production at a troubled Indian facility and expects to start shipping APIs to the US in the next few weeks.

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.

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