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Nitto Denko Avecia to buy Irvine and Avrio to expand offering

20-Oct-2016 - Nucleic acid manufacturer Nitto Denko Avecia has agreed to buy Irvine Pharmaceutical Services and Avrio Biopharmaceuticals in deals designed to expand its production business.

Merck completes expansion of Madrid Gonal-f API plant

19-Oct-2016 - Merck has completed the expansion of its biologics API manufacturing facility in Madrid, Spain increasing production capacity by 50%.

BASF halts production at Ludwigshafen plant after deadly explosion

18-Oct-2016 - BASF is confident the shutdown of its site in Ludwigshafen, Germany will not disrupt the supply of drug excipients.

WHO adds gatifloxacin to prequalification list to encourage API manufacturers

17-Oct-2016 - The WHO has added side-effect heavy, TB drug ingredient gatifloxacin to its prequalification list to encourage production.

News in brief

CMC Biologics and IDT Biologika expand ADC manufacturing collaboration

13-Oct-2016 - CMC Biologics and IDT Biologika have added Cerbios-Pharma SA and Oncotec Pharma Produktion GmbH to the companies’ PROVEO Partnership – a strategic collaboration for manufacturing antibody drug conjugates (ADCs).

Online API platform could help secure supply chain, says consultancy firm

12-Oct-2016 - Finding and validating an ingredient supplier can take up to 26 weeks says consultancy firm Rephine, which hopes to address the burden through an online API sourcing platform.

update: Nandu confident it can resolve issues

Falsification practices: French regulators call for Nandu Chemicals' API site ban

10-Oct-2016 - French regulators have recommended that drugs containing APIs made at Nandu Chemicals Industries’ site in Hubli, India be recalled after uncovering “serious” problems during an inspection in August.

Barcelona welcomes API manufacturers and pharma firms

03-Oct-2016 - is in Barcelona to hear about market and regulatory developments in the API and CMO sectors. Check back for updates.

How to get the most out of CPhI - a survival guide for pharma's biggest tradeshow

03-Oct-2016 - CPhI Worldwide is a marathon not a sprint says marketing guru Raman Sehgal who has written a survival guide for folks going to the drug industry’s biggest tradeshow.

AbbVie API plant opens in Singapore as first part of larger $320m site

29-Sep-2016 - AbbVie has opened an oncology and women’s health API plant, part of its planned 120,000m2 small and large molecule manufacturing site in Singapore.

US FDA: Cheng Fong Chemical must do more to investigate complaints

28-Sep-2016 - Cheng Fong Chemical has addressed problems at its Taoyuan City plant but still needs to identify the source of foreign matter found in its APIs according to the US FDA.

Moody's maintains B1 rating of merger-bound Avantor

27-Sep-2016 - Avantor Performance Materials has had its positive rating reiterated by Moody’s just days before its merger with Nusil Technology is expected to complete.

BASF set to start making PVP in China

27-Sep-2016 - BASF is poised to start making polyvinylpyrrolidone (PVP) at its facility in Shanghai, China after completing work on a $70m (€62m) manufacturing expansion.

Cambrex bolstering API services through $25m PharmaCore acquisition

26-Sep-2016 - Cambrex will acquire clinical-scale API maker PharmaCore for $25m adding a standalone GMP facility in North Carolina approved to make Schedule II to V products.

DSP: Pharmas must be open about API suppliers to fight antibiotic resistance

26-Sep-2016 - Drug companies need to me more open about their API suppliers to help fight the spread of antimicrobial resistance (AMR) according to DSM Sinochem Pharmaceuticals.

Urine derived clot busters do not pose Zika risk says EMA

22-Sep-2016 - Clot busting drugs derived from human urine are no more likely to be contaminated with Zika virus than other medicines according to research by the EMA.

US FDA warns API firm Hebei Yuxing Bio-Engineering

21-Sep-2016 - Banned API firm Hebei Yuxing Bio-Engineering has had a microbial contamination problem at its plant since 2013 according to the US FDA.

Johnson Matthey's refurbished Annan API plant passes MHRA GMP inspection

20-Sep-2016 - The UK MHRA has awarded Johnson Matthey’s API facility in Scotland a GMP certificate.

Indoco Remedies stresses that Form 483s are not data integrity related

14-Sep-2016 - Indoco Remedies says problems the US FDA identified at an ophthalmic and injectable drug plant in Goa, India last month are “correctable.”

Cambrex investment continues as industry trends ‘remain favorable’

07-Sep-2016 - The latest in a series of investments, Cambrex has recently expanded its Sweden-based site as part of its ongoing investment in small molecule API manufacturing across its global network of facilities. 

AMRI expects to make layoffs during Euticals integration

07-Sep-2016 - AMRI has said integrating recent Italian acquisition Prime European Therapeuticals, also known as Euticals, will involve layoffs.

Avara to buy ex Crestor API plant from AstraZeneca

07-Sep-2016 - Avara Pharmaceutical Services will buy the UK manufacturing facility at which AstraZeneca made the API for Crestor and Seroquel.

More Cambrex capacity expansion: API firm to grow Karlskoga facility

07-Sep-2016 - Cambrex will spend $9m (€8m) to add large-scale manufacturing capability at its API production facility in Karlskoga, Sweden.

IPEC China joins EXCiPACT, promoting excipient safety, quality

07-Sep-2016 - The global excipient certification organization has announced IPEC Association (China) Limited as its fifth member, joining IPEC Europe, IPEC Americas, FECC, and PQG (UK).

Chemical fast-track could speed up nitrile drug synthesis

06-Sep-2016 - A synthetic short cut could make it easier and cheaper to produce nitrile-containing compounds, a group which includes dozens of marketed and pipeline drugs.

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