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UK Moves to Prevent API Shortages Ahead of New EU Import Laws
18-Jun-2013 - The UK MHRA plans to let drugmakers import APIs that lack ‘written confirmation’ of quality if there is an overriding need to ensure continued supply.
EC welcomes list of Indian API suppliers with ‘written confirmation’
13-Jun-2013 - The European Commission has welcomed the publication of the list of Indian API makers issued with “written confirmations” of quality by the CDSCO.
Biosimilar Developers Seek Clarity on US FDA Draft Guidance
13-Jun-2013 - Biosimilar developers such as Mylan and Pfizer are taking issue with FDA draft guidance that in some circumstances could extend biosimilar development timelines and discourage their development.
Is Pharma Excommunication Discouraging Potential Whistleblowers?
13-Jun-2013 - 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.
Some China API Firms Wont Have 'Written Confirmations' by July says blue inspection body
12-Jun-2013 - 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.
Teva's Packaging Switch Maybe Caused By Human Interference
12-Jun-2013 - Malicious tampering could be behind the Furosemide packaging mix-up that may have led to several deaths in France, according to Teva.
Baxter Pulled Up on Repeat GMP Violations at NC and Puerto Rico Plants
12-Jun-2013 - Failure to clean up unsanitary conditions at a US plant and address cGMP violations at a facility in Puerto Rico have earned Baxter another warning from the US FDA.
Japan Gets 'Third-Country' Status to Import APIs to the EU after Impending Deadline
10-Jun-2013 - 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.
Cali Plant Remediation 'Impax' 110 Jobs, Mostly Manufacturing
06-Jun-2013 - 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.
US FDA Looks to Regulate Laboratory-Developed Diagnostic Tests
04-Jun-2013 - The Commissioner of the FDA says laboratory-developed diagnostic tests needs to be regulated for clinical validity to stop erroneous results and ensure patient and clinician confidence.
Propofol Off FDA List but Manufacturing Issues Cause 75% of Shortages
04-Jun-2013 - As propofol comes off its shortages list, the FDA says manufacturing problems still cause the majority of supply issues though legislation has helped to alleviate this.
US House Passes Track-and-Trace Legislation to Secure Supply Chain
03-Jun-2013 - The US House of Representatives has passed a bill by voice vote that would for the first time create a system to track and trace drugs through the supply chain.
USP Delays Deadline for Industry to Comply With Elemental Impurity Standards
03-Jun-2013 - USP has decided to delay the implementation of two general chapters on elemental impurities until ICH has further established its own impurity testing requirements.
CorePharma: GMP Confident, Ready to Relaunch After FDA Closeout Letter
03-Jun-2013 - Three years after receiving a warning letter for GMP violations, CorePharma says it is in a full state of compliance and ready to relaunch products.
Clinical Investigator Hit with US FDA Warning Letter for Falsified Data
29-May-2013 - The US FDA has sent a warning letter to a clinical investigator after he failed to take adequate action on falsified data in a study he oversaw.
Voluntary Drug Recalls from Fresenius, J&J and Glenmark
28-May-2013 - Fresenius Kabi says drug shortages won’t be affected as it recalls a lot of magnesium sulphate, and there’s news from Glenmark and J&J – welcome to in-Pharmatechnologist.com's recall round-up.
EMA Updates Inspector Expectations for API Audits
27-May-2013 - 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.
Wockhardt to Suffer Revenue Loss After FDA Import Alert
27-May-2013 - Generic firm Wockhardt has received a US import alert from for all drugs from its Indian plant.
Sandoz Recalls Injectable Following Contamination at Austrian Plant
23-May-2013 - Sandoz has recalled two lots of an injectable drug after vials were discovered to contain foreign matter, though is unsure of the cause for now.
Pfizer Takes Issue with European Commission’s Plans to Regulate ATMPs
23-May-2013 - 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).
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