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.
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.
Chinese oversight of API plants is improving, but it is still important EU importers choose their sources carefully says European Medicines Agency (EMA) collaboration chief, Emer Cooke.
Drugmakers struggling with new EU API import rules now have details of the risk assessments that could solve their problems thanks to the Heads of Medicines Agencies (HMA).
Despite recent progress, the EC underestimated the challenge of getting non-EU regulators to ensure APIs shipped to the European Union (EU) meet new import requirements according to Eucope.
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.
Cost of freight, customer service and regulatory compliance offer Western CMOs advantages over their Eastern Counterparts, according to US CMO Pharma Tech Industries (PTI).
In an effort to stave off expected drug shortages, the EC has approved a waiver that will allow US API manufacturers to export their products to Europe.
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).
Phyton Biotech has received European approval for a version the cancer drug API docetaxel whose production does not rely on the scarce yew tree extract used in traditional manufacturing methods.
Europe could face drug shortages if the US is not granted exemption from new API import requirements, according to a US chemical industry trade association.
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.
Some Chinese firms wont have the 'written confirmations' required to ship APIs to the EU from July according to the German audit firm tasked with helping manufacturers prepare by Beijing industry group, CCCMHPIE.
The Japanese joint venture between Dr. Reddy’s and Fujifilm has been called-off though both say future collaboration remains likely, especially in API production.
Japan has become the third country outside the EU to be exempt from providing written confirmation that APIs imported into Europe have met required standards when legislation commences on July 2nd.
Janssen has recalled 179 batches of an oral contraceptive after problems with the release of the active pharmaceutical ingredient (API) were discovered.
USP has decided to delay the implementation of two general chapters on elemental impurities until ICH has further established its own impurity testing requirements.
The US FDA is allowing Fresenius Kabi USA to import trace elements and phosphate injections from its Norway plant to help improve a critical shortage of components of total parenteral nutrition (TPN).
As new API regulations are set in July for those outside the EU, the European Medicines Agency (EMA) has unveiled what its inspectors expect to see from API manufacturer or supplier audit reports from inside the region.
Pfizer and other EU industry and academic groups are calling on the European Commission to revise its plans for authorizing and regulating ATMPs (advanced therapy medical products).
Differences in elemental impurity standards being developed separately by the US Pharmacopeia and ICH could mean costly reformulations according to a pharmaceutical, API and excipient industry coalition.
Making amide bonds may be greener and cheaper in the future according to Aesica, which has partnered with UK scientists to commercialize a new synthesis technique.
Looking to align with other industrialized nations, Canada has agreed to extend its GMP requirements for all active pharmaceutical ingredients (APIs), according to a notice in the Canada Gazette.
Large scale manufacturing contract revenue in the first quarter of 2013 increased 14% over the same quarter in 2012 as AMRI (Albany Medical Research Inc.) saw an 11% increase in overall revenue.
The EMA may recommend new daily exposure limits for some phthalates as animal data have shown they can cause negative reproductive and development effects, according to a new draft guideline.
In a rare move, the FDA has publically released Alexion Pharmaceuticals’ response to a Form 483 following inspection of its US site and the discovery of microbial contamination.
Two NGOs responsible for safeguarding plants and forests have positively reviewed the harvesting practices of a prostate-benefitting botanical harvested in Cameroon.
Revised excipient guidelines expected from Brazilian regulator Anvisa this year will reduce confusion and further align standards with those in the US and EU says an industry expert.
Dispatches from Excipient Fest in Baltimore - UPDATE
As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and excipients, questions still remain on whether the manufacturers will be able to comply with the looming requirements.
China’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have added another layer of safety requirements but challenges remain for the regulators in ensuring compliance, experts say.
Manufacturing disruptions at Lonza's Hopkinton, Massachusetts site are causing shortages of Ipsen Biopharmaceuticals’ growth failure treatment for children in both the US and EU, just as the company announces that it will shutter another manufacturing...
The FDA has finalised guidance on the manufacturing of antibiotics in order to prevent cross-contamination of finished pharmaceuticals and APIs with non-penicillin beta-lactam drugs.
The inventor of a reagent recently found to be highly explosive says many drug production chemicals may have similar profiles and that knowing how to handle them is the key.
GlaxoSmithKline’s contract manufacturer has experienced unspecified manufacturing issues that are expected to set back supplies of its restless leg treatment Horizant until June.
