Almost one in five active pharmaceutical ingredient (API) facilities inspected by the European Directorate for Quality of Medicines and Healthcare (EDQM) last year failed to meet quality standards.
The US FDA has banned Phalanx Labs from shipping products to the US after the Indian API and intermediates firm refused to let inspectors visit its site in Visakhapatnam.
Brazil’s ANVISA has cleared Cristália Laboratory to make an API for an over-the-counter (OTC) burns treatment at a recently established $40m biomanufacturing facility in Itapira, Sao Paulo.
Organisations that identify API manufacturers whose manufacturing activities spread antimicrobial resistance will be considered alongisde other NGOs for a new European Commission award.
The US FDA has told Megafine Pharma it must determine the extent of data falsification at the plant in Nashik, Maharashtra that was banned from shipping APIs to the US last year.
Xellia Pharmaceuticals has started building a stability and release-testing unit at its API facility in Budapest, Hungary that is designed to support increased output.
Selcia has opened a production facility for 14C radiolabelled drug ingredients in the UK citing growing demand from CROs and sponsors running first-in-man studies.
Indian API maker JP Laboratories is unable to sustain GMP compliance at its facility in Daund, Maharashtra according to the Italian Medicines Agency (IMA).
APIs made by Krebs Biochemicals and Industries at its facility in Visakhapatnam, India pose a ‘critical risk’ to public health according to Italian regulators.
Ajinomoto Althea has been granted a US patent for a whole antibody crystallization method that is faster at producing stable, biologically-active crystals than current techniques.
As “one of the fastest growing areas in pharma,” the demand for finished dosage formulations is having an impact on several aspects of the CMO industries.
Suir Pharma is set to close or be sold with the loss of 130 jobs less than a year after it was acquired by Slovakian API manufacturer Saneca Pharmaceuticals.
Envirotainer has opened a ‘service station’ in Delhi, India to help local API and generic drug manufacturers comply with international shipping regulations.
An API facility Cambrex is setting up in Charles City, Iowa will be operational later than planned due to delayed equipment deliveries and installation challenges.
Indian firm Polydrug Laboratories failed to investigate complaints about APIs containing foreign bodies including hairs and insects, the US FDA says in a Warning Letter.
AstraZeneca will supply Ironwood Pharmaceuticals with the API and finished dosage form of the gout drug Zurampic under the licensing deal agreed this week.
The WHO has removed two APIs supplied by Anuh Pharma from its list of prequalified ingredients and announced plans to inspect the firm’s facility in Boisar, India.
API manufacturer PCI Synthesis has set up a polymer development group citing growing drug industry demand for advanced coating technologies and excipient technologies.
A European chemical industry group has reiterated that gelatin is safe after Indian regulators called for feedback on a plan to replace the excipient with cellulose in pharmaceutical capsules.
