The US FDA has asked Sekisui Medical to specify how it will resolve data integrity issues uncovered during an inspection of its API plant in Hachimantai, Japan in June.
Eagle Pharmaceuticals Inc. has announced its intention to buy Arsia Therapeutics citing its formulation viscosity reduction platform as the driver for the deal.
The US FDA has almost cleared a backlog of 4000 excipient formulations in its Inactive Ingredient Database (IID) and wants drugmakers to help ensure ongoing accuracy.
Cempra has asked Uquifa for API manufacturing data to support its US solithromycin efforts after raising concerns that information from Wockhardt in the current dossier will delay review.
Smaller drugmakers are shifting away from generics and towards niche new molecules says Recipharm, which has expanded a small-scale API facility to feed demand.
Data integrity issues and the unexplained disappearance of drums of pharmaceutical ingredients have landed a Chinese API maker with a US FDA warning letter.
Lonza has raised its 2016 guidance and predicted higher spending on manufacturing equipment after growth of its biopharma businesses in the third quarter.
The US FDA wants more information on Czech API firm Interpharm Praha AS’s efforts to prevent repetition of data manipulation uncovered during 2015 inspection.
Nucleic acid manufacturer Nitto Denko Avecia has agreed to buy Irvine Pharmaceutical Services and Avrio Biopharmaceuticals in deals designed to expand its production business.
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).
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.
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.
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.
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.
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 is poised to start making polyvinylpyrrolidone (PVP) at its facility in Shanghai, China after completing work on a $70m (€62m) manufacturing expansion.
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.
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.
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.
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.
The global excipient certification organization has announced IPEC Association (China) Limited as its fifth member, joining IPEC Europe, IPEC Americas, FECC, and PQG (UK).
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.
Xinxiang Tuoxin Biochemical has received a US FDA warning letter after manufacturing equipment at two API facilities were found to be in a state of disrepair.
Pfizer will buy most of AstraZeneca’s antibiotics business in a $1.5bn (€1.32bn) deal that will see the Anglo-Swedish drug firm continue to package Merrem at its Macclesfield, UK plant for at least the next 18 months.
Scientists in Switzerland have developed a simple and cheap way to synthesise amines - compounds that form the backbone of many active pharmaceutical ingredients.
Phyton Biotech has developed a cell based way of making thapsigargin, a cytotoxic plant extract that is being developed for the treatment of cancer by Inspyr Therapeutics.
Siegfried Holding AG has attributed a surge in API sales to the drug ingredients business it bought from BASF last year, but says that integration costs hurt profits.
The US FDA wants to reclassify pharmaceutical co-crystals as solvates rather than intermediates to reduce the regulatory burden on manufacturers that work with them.
