Article archive

Actavis to close NC plant, trim 310 jobs

18/11/2013 13:50
Actavis CEO Paul Bisaro said from the beginning that he intended to close some of the 28 plants acquired in the buyout of Actavis ($ACT) by Watson Pharmaceuticals last year. A plant in North Carolina will be among those. It is a tough break for the 310 workers at the facility but will provide some...

Pharma in India scrambles to appease wholesalers, chemists

18/11/2013 13:38
Nobody making or selling drugs in India was happy when the government this year expanded price caps to nearly 350 drugs, but there seemed little for anyone to do. When wholesalers and retailers began holding off on new orders to protest their pared-back margins, a move that led to GlaxoSmithKline...

GSK expanding further in India with £85M facility, CEO Witty says

18/11/2013 13:35
GlaxoSmithKline ($GSK) expects increasing amounts of business from emerging markets, and so, to get ahead of the curve in India, the company is planning to build a new £85 million ($136.5 million) plant there. CEO Andrew Witty made the announcement himself while in the country for a conference. The...

J&J, Merck KGaA move forward with new China investments

18/11/2013 13:32
The investigation by Chinese authorities into of a host of drugmakers for bribery has put a chill on business there, but not frozen them in their tracks. Plans announced in the last two days by Johnson & Johnson ($JNJ) and Merck KGaA to build new plants in China show the market is too vast and...

New FDA Requirement on the Handling of INDs

18/11/2013 13:28
FDA has put into effect the internal Manual of Policies and Procedures MAPP 6030.9 on good review practices for applications submitted for new drugs (IND = investigational new drug applications) in April 2013. This document is supposed to provide a consistent approach to the handling of submissions...

FDA published List of GMP facilities producing for the US market (generic drug products and APIs)

18/11/2013 13:20
The US FDA has published a comprehensive list of facilities that produce Finished Dosage Forms and APIs under the Generic Drug User Fee Act. The list also includes packaging facilities, repackers, analytical testing laboratories and facilities for clinical bioequivalence or bioavailability studies....

USP proposes Chapter on Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems

18/11/2013 13:17
During the last years, leachables and extractables testing became more and more important for the quality of the packaging systems used to store drug products. The suitability of a pharmaceutical packaging system for a drug product can be assessed by extractables and leachables testing. Out of...

European QP Association initiated a database comprising shared audits information

18/11/2013 13:13
One of the most important tools in supplier qualification is the on-site audit. Although the QP is not obliged to perform the audit him- or herself, the responsibility stays with the QP. A possibility in saving resources is sharing an audit. For that reason the European QP Association initiated a...

New Q&A Document of the CMDh gives Answers to Essential Questions on the ASMF Procedure

18/11/2013 13:11
The Co-ordination Group of Mutual Recognition and Decentralised Procedures (CMDh) has published a Questions & Answers document regarding the Active Substance Master File (ASMF) procedure. In this document, the CMDh has clariified some issues which were still open and essential for the ASMF...

Updates from the US on particles in injectables

18/11/2013 13:08
Particles in injectable products are still a hot topic in 2013. According to the FDA, almost one quarter of all recalls of injectable drugs during the last five years was caused by particles. It is likely that some of these recalls might have been avoided by a better visual inspection system. Also...
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