EMA Biosimilars Draft: Non-EU Reference Avoids Clinical Trial Repeats

21-May-2013 - The EMA (European Medicines Agency) has released draft guidelines on biosimilars allowing non-EEA comparators to be used in limited circumstances.

Coalition Calls for Science-Based Approach to Elemental Impurity Testing

15-May-2013 - 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.

EMA Seeks to Revise Some Phthalate Limits in Excipients

08-May-2013 - 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 .

Dispatches from Excipient Fest in Baltimore

Brazil’s Anvisa to Publish Revised Excipient GMP Guideline

06-May-2013 - 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

Confusion Abounds in Elemental Impurities Testing for Pharma, Excipients

02-May-2013 - 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.

Dispatches from Excipient Fest in Baltimore

China Looks to Tighten Excipient Regulations with Limited Resources

02-May-2013 - 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.

Prof Says Knowing How to Handle Dangerous Reagents is Key

22-Apr-2013 - 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.

update

Key Drugmaking Reagent As Inflammable as Gunpowder Warns Novasep

16-Apr-2013 - Novasep has discovered that the drug manufacturing regent Togni II is highly explosive and as inflammable as gunpowder.

BD Forms Pharmaceutical Wing with New Prefilled Generic Injectables

28-Mar-2013 - BD says a brand new facility and sustainable pricing will allow the company to compete as it enters the generics market following FDA approval of its first injectable drug. 

Updated Excipient Package User Guide Aims to Reduce Redundancy for Suppliers

27-Mar-2013 - As excipient suppliers are inundated with similar requests from users regarding quality and raw material sources, IPEC (International Pharmaceutical Excipients Council) is looking to streamline the exchange of information between the different companies.

API Corp. Invests in Neuland for More API, Intermediate Manufacturing

14-Mar-2013 - Tokyo-based API Corporation, a unit of Mitsubishi Chemical Holdings Group, is making an investment in API and pharmaceutical manufacturer Neuland Laboratories’ facilities.

Catalent Focuses on Softgel in One of Two Chinese Ventures

13-Mar-2013 - Catalent says it has acquired a Chinese softgel producer to expand its drug delivery offerings and expects more investments to come as part of a two-pronged plan into China.

Patheon to Shutter Manufacturing Plant as Part of Banner Integration

12-Mar-2013 - Patheon says the shuttering of one of Banner’s manufacturing sites is necessary in integrating the recent acquisition into its global business structure.

Update

Ashland to Expand Delaware Formulation and Contract Manufacturing

11-Mar-2013 - Ashland says it is expanding its contract manufacturing business in order to offer its customers greater scope in drug solubilization.

EMA proposes virus testing for food sector-derived trypsin used in drugmaking

06-Mar-2013 - Food industry controls do not ensure porcine trypsin is virus-free according to the EMA, which proposes testing procedures for drugmakers which use the reagent in a new consultation document.

update

SAFC Expands Manufacturing Capacity to Meet Growing EU Needs

05-Mar-2013 - SAFC will expand manufacturing capacity at its facility in Irvine, Scotland, to include large-scale production of bulk dry powder media and reagents to save EU clients’ money in shipment costs.

Raman Spectroscopic Device in Fight Against Counterfeit Drugs

27-Feb-2013 - As an FDA commissioned report on counterfeit drugs is released the potential to detect them may lie in a handheld API analyzing device.

BASF says Bend Accord Targets Different Chemistries than Dow deal

25-Feb-2013 - Bend Research has partnered with its second chemistry major in six months, teaming up with BASF to develop bioavailability-boosting excipients.

Capsugel Launches New Oral Formulation Business Unit

21-Feb-2013 - Capsugel says it will focus on lipid-based formulations as it launches a new Dosage Form Solutions Business Unit.

Collaboration With Britest Already Paying Off Says Aesica

21-Feb-2013 - UK CMO Aesica claims its partnership with process innovation group Britest has already increased capacity without capital investment.