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APIs (active pharmaceutical ingredients)

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Laxachem Organics ban not linked to B. cepacia outbreak says US FDA

24-Oct-2016 - APIs made by Laxachem Organics pvt ltd were not the source of bacteria in Pharmatech laxatives linked to a spate of Burkholderia cepacia infections according to the US Food and Drug Administration (FDA).

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%.

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.

Roller compactor bolsters Juniper's granulation capabilities

17-Oct-2016 - CDMO Juniper Pharma Services has added a small-scale roller compactor as the latest investment in its enabling technology offerings.

FDA and CDC links B. cepacia outbreak to contamination at PharmaTech

13-Oct-2016 - The US FDA has found a direct link between contaminated water at CMO PharmaTech and a multistate B. cepacia outbreak.

Pfizer on CMOs: $180bn is at stake so being first-to-market is critical

13-Oct-2016 - With the top 500 molecules in development having a commercial potential of $180bn by 2022, being first-to-market is critical says Pfizer.

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.

Dispatches from CPhI

APIC concerned about EU API import rules

06-Oct-2016 - European Union API import rules do not ensure ingredients shipped to Europe are of appropriate quality according to APIC board member, Marieke Van Dalen.

Dispatches from CPhI

Continuous manufacturing: pharma adoption challenges remain according to CMAC

06-Oct-2016 - Economics, regulatory inexperience and a lack of technical skills are holding back drug industry adoption of continuous manufacturing says CMAC industrial director, Craig Johnston.

Dispatches from CPhI Worldwide 2016

Capsugel: enteric polymer comprising tech can speed-up drug development

04-Oct-2016 - Capsugel’s Vcaps Enteric offering can speed up development of delayed release drugs by removing the need for an additional enteric film coat, the firm says.

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.

GDUFA II negotiations: CMOs to pay one third of facility fees

29-Sep-2016 - The Pharma & Biopharma Outsourcing Association (PBOA) has helped negotiate reduced fees for CMOs in the FDA’s proposed reauthorisation of the Generic Drug User Fee Amendment (GDUFA).

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.

China made APIs shipped to fake Viagra lab via UK say Polish police

28-Sep-2016 - Viagra counterfeiters in Poland imported APIs made in China via the UK, Greece and Romania according to police who shut down a major manufacturing operation last week.

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.

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.

Moderna to spend $110m on mRNA therapeutics manufacturing plant

21-Sep-2016 - Moderna Therapeutics has announced plans for a $110m (€98m) API manufacturing facility for its pipeline of mRNA therapeutics.

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