Evertogen Life Sciences Limited should recall drugs made at its facility in Mahabubnagar, India according to the MHRA, which identified critical quality and data integrity problems during an audit in August.
The pharma world has converged in Frankfurt, Germany for this year’s CPhI Worldwide. In-Pharmatechnologist is here too to report the latest trends affecting the industry.
The New Jersey Innovation Institute and Rutgers University have teamed up to establish an institute to promote the development of continuous manufacturing technologies for drug production.
AMRI is offering its impurity solutions as a stand-alone service in response to new regulatory requirements that set limits for the amounts of elemental impurities in drug products.
BioMoti and Pharmidex have received funding to advance proof-of-concept precision medicine studies – which if successful, could help secure pharma partnerships or additional investment, says BioMoti CEO.
Cambrex Corporation has announced plans to start making high potency APIs at its plant in Milan, Italy citing impending patent losses for small molecule drugs as an opportunity.
ShangPharma Innovation and SRI International are collaborating to develop treatments for neurodegenerative and inflammatory conditions, such as Alzheimer’s disease.
Nestle Health Science has licensed a protein engineering platform from Codexis in a $14m deal that includes an option to co-develop a phenylketonuria drug candidate called CDX-6114.
China has announced that it will now accept clinical trial data from other countries in a new guideline that aims to reform the management of clinical trials.
Depomed Inc. says supplies of the extended release version of Nucynta will be delayed as a result of damage to a Puerto Rico manufacturing plant caused by hurricane Maria.
CordenPharma will supply Pfizer with highly potent active pharmaceutical ingredients (HPAPIs) from the facility in Boulder once earmarked for closure by the Big Pharma firm.
Marken has acquired Touchdown International Ltd, a privately held specialty logistics company in Taiwan – a “key market” for pharma production and clinical trials.
Antimalarial drug resistance in Southeast Asia is threatening the control and elimination of malaria, and drug makers can help, says a tropical medicine expert.
Police investigating thousands of adverse events linked to Levothyrox, a reformulated version of the hypothyroidism pill Euthyrox, have visited Merck KGaA's production facility in Lyon, France.
Ergomed is bolstering its orphan drug development services with its acquisition of PSR Group BV in a deal worth up to €5.7m ($6.69m) – which will position the company to be a “global player” in the area, says CEO.
According to industry delegates, smaller contract services firms struggling to meet track & trace implementation costs will look to consolidate with competitors in light of impending serialisation deadlines.
Ajinomoto Althea, Inc. has opened a GMP production suite in its newly constructed High Potency Products (HPP) commercial manufacturing facility in San Diego, CA.
Patheon is “better positioned” to serve clients following the Thermo Fisher Scientific Inc. acquisition, says CDMO president, whose initial focus will be integration.
The clinical research environment in Japan has evolved dramatically since Parexel first began operations in the country, says the CRO, who recently established an alliance with a local cancer institute.
The biometrics contract research organization (CRO) and clinical trial software provider is continuing with its expansions plans as it opens a new office in King of Prussia, Pennsylvania.
A new formulation of Euthyrox linked to a surge in adverse event reports in France is safe, effective and more consistent than the older version of the drug say ANSM and Merck.
US WorldMeds has teamed up with Catalent Pharma Solutions to manufacture lofexidine, an investigational drug designed to treat symptoms associated with opioid withdrawal.
Outsourcing-Pharma's State of the Global Pharmaceutical Contract Services Industry
The global pharmaceutical contract services industry continues to face several challenges and changes, from ubiquitous consolidation among all industry players to uncertainty in a turbulent political climate.
Pfizer, Merck & Co (known as MSD outside of North America) and GlaxoSmithKline (GSK) have come together to support the development of continuous manufacturing and bio-catalysis technologies in Singapore.
Janssen and Mundipharma have expanded their alliance through which Munipharma will sell, market, and promote medicines for the Belgium-headquartered pharma company.
Siegfried Holding AG saw higher earnings in the first half of 2017 with cost synergies offsetting the negative impact facility maintenance work had on its API business.
CordenPharma Latina has resolved the problems that earned its API and injectable drug facility in Sermoneta, Italy a warning letter from the US FDA last year.
Price controls and procurement programmes would favour drugs containing locally-made APIs under a Government proposal designed to reduce India's reliance on imported ingredients and intermediates.
