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).
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.
19-Oct-2016 - Merck has completed the expansion of its biologics API manufacturing facility in Madrid, Spain increasing production capacity by 50%.
17-Oct-2016 - The WHO has added side-effect heavy, TB drug ingredient gatifloxacin to its prequalification list to encourage production.
17-Oct-2016 - CDMO Juniper Pharma Services has added a small-scale roller compactor as the latest investment in its enabling technology offerings.
13-Oct-2016 - The US FDA has found a direct link between contaminated water at CMO PharmaTech and a multistate B. cepacia outbreak.
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.
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.
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.
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.
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.
03-Oct-2016 - in-Pharmatechnologist.com is in Barcelona to hear about market and regulatory developments in the API and CMO sectors. Check back for updates.
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).
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.
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.
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.
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.
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.
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.
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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