Chinese understanding of European CEPs is good, but some manufacturers are still unclear on the related obligations and requirements according to auditing firm, blue inspection body.
Molecular Profiles has received the regulatory thumbs up on a second manufacturing facility and says it can offer its clients a breadth of services uncommon for CMOs.
Over the next 10 years CMO Corgenix will contract manufacture EDP Biotech’s diagnostic test to detect the early stages of colon cancer, the companies agreed last week.
After patent expiration led to facility shuttering and cutbacks, Irish manufacturing will receive a $130m (€100m) boost to prepare for Pfizer’s new pipeline, the company says.
Rebuilding 'problem' sterile manufacturing plants to modern specifications may be a better option than spending money trying to fix them according to an ex-GSK expert.
Saltigo has won a manufacturing contract with Daiichi Sankyo under it which it will provide custom synthesis services for one of the Japanese drugmaker’s pipeline candidates.
Wockhardt remains confident its troubled manufacturing facility in India will be back up and running in three months after receiving a certificate of non-compliance from the MHRA.
IPPT has announced plans to buy tablet press maker Kilian for €21m from IMA citing the German firm’s patent portfolio and Asian reach as the key drivers.
Pharma firms are returning to European and North American manufacturers as quality issues and rising costs have lost India and China some of its ‘Eastern promise,’ according to industry experts.
The EMA says new import laws and international collaboration means European drugmakers can now rely on the quality of APIs made outside the European Union.
The Aspen Group, a generic pharmaceutical company, is moving further into the manufacturing business with the purchase of Merck’s API manufacturing sites in the Netherlands and Iowa.
The parallel QbD (Quality by Design) application review program by the US FDA and EMA is slowly revealing the differences between the two agencies but will never result in identical assessments or outcomes, experts said.
Critical Pharmaceuticals says its protein and peptide delivery technologies offer long acting injectables and greater compliance, saving money and easing patient administration.
With small companies and biotechs increasingly discovering new products, there are big opportunities for contract development and manufacturing organisations (CDMO), says ex-GSK expert.
Cost of freight, customer service and regulatory compliance offer Western CMOs advantages over their Eastern Counterparts, according to US CMO Pharma Tech Industries (PTI).
SCM Pharma says its new contract manufacturing facility will cater for clients upscaling towards commercial production and the trend towards orphan drugs.
The Brazilian Government is to fund a new facility to produce the Protalix-Pfizer Gaucher's disease drug Uplyso as part of a supply and tech transfer deal worth $280m (€212m).
Ash Stevens is planning to expand its API manufacturing facility in Michigan, which was recently approved by the US FDA to produce Ariad Pharmaceuticals’ oncology drug Iclusig (ponatinib).
The DEA has approved AMRI’s Burlington facility to work with Schedule 2 controlled substances, placing it in a competitive position to win contract manufacturing bids, the company says.
Ambrx and Zhejiang Medicine have selected Wuxi to accelerate the development of a potential ADC (antibody drug conjugate) targeting Her2-positive breast cancer.
Shasun Pharmaceuticals’ says it is trying to restart operations at the earliest opportunity after workers went on strike at its API and formulation facility in India last Sunday.
Lonza has launched a service to help biopharmas decide if promising protein drug candidates are worth developing, from an immunogenicity and manufacturing standpoint.
Catalent says customers are applying controlled release technology to transform drugs into better treatments across all stages of development as it expands its Kentucky manufacturing site.
Pharma employees who report manufacturing misconduct to stop adulterated drugs getting to market put their careers at risk and face being blackballed by industry says an American advocacy group.
Canadian CMO Patheon’s second quarter revenues increased almost 40 percent as the company’s commercial manufacturing services revenues saw a similarly high rise over the same period from last year.
Boehringer Ingelheim will build a biomanufacturing facility in Shanghai in a strategic alliance designed to cater for Pharmas nervous about setting up plants in China.
Impax Laboratories says it remains committed to resolving manufacturing issues at its troubled Californian plant though 110 jobs will go as production continues to be transferred to Taiwan.
The state of Indiana has unveiled a new industry-led Biosciences Research Institute though it is unclear how companies will divide intellectual property and product patents.
