The second draft of Excipact, a set of certification standards for drug excipient producers being developed by the EFCG, FECC, IPEC and PQD, has been sent to industry stakeholders for consultation.
Royal DSM NV says its pharmaceutical contract manufacturing business model is ‘out of step with market needs’ after the unit’s Q1 performance blots an otherwise positive set of financials.
The United States Pharmacopeial Convention (USP) and the Chinese Pharmacopoeia Commission (ChP) have made mutual executive appointments in an effort to further align drug quality standards.
The top seven CROs will have captured half the market by 2015 as big pharma, including Pfizer, enters into strategic relationships with major players, Jeffries & Company said.
Clinical trial sites must take a proactive approach to non-compliance by identifying risks and having corrective action plans, says a former FDA investigator.
French preclinical contract research organisation (CRO) CIT has said it will buy Canadian counterpart LAB Research in a deal that would rescue the Quebec-based firm from the receivers.
Microbiology media maker Cherwell Laboratories has announced plans to expand its manufacturing capacity in response to growing industry demand for environmental monitoring products.
US drugmaker Amgen has acquired Brazilian manufacturer Bergamo in a bid to improve its access to ‘one of the fastest growing pharmaceutical markets in the world.”
Contract research organisation (CRO) Clearstone Central Laboratories has unveiled a ‘preferred provider’ partnership with Mitsubishi Chemical Medience (MCM), continuing its efforts to expand in Asia.
LB Bohle says healthy level of demand for processing technology demos at its recently opened service centre is an indication of processing tech market recovery.
Unilife has begun a ‘scheduled realignment’ of its operating infrastructure to support the production and sale of its Unifill prefilled syringe, according to a statement released by the company.
Contract manufacturing organisation (CMO) Patheon has launched a new ‘back up’ sterile manufacturing service to help drug firms cope with supply interruptions and, it hopes, attract new business.
The pharmaceutical manufacturing sector in Puerto Rico will thrive because of and not in spite of changes to the country’s tax and incentive laws according to the Puerto Rico Industrial Development Company (PRIDCO).
Chiltern International, a global contract research organisation (CRO) has expanded its European operations with the opening of a new office in the Netherlands.
Novartis has acquired a majority stake in vaccine maker Zhejiang Tianyuan Bio-Pharmaceutical, continuing its efforts to accelerate revenue growth in China.
Almac Pharma Services has expanded its cold storage capacity for biopharmaceuticals, continuing the contract manufacturing organisation’s (CMO) busy expansion programme.
Gerresheimer has bought Brazilian pharmaceutical plastic packaging maker Vedat, citing rapid growth of the country’s drug market, particularly the generics segment, as the main driver for the acquisition.
ShangPharma said it saw revenue climb on higher customer spending in the fourth quarter, but that margins slid due to currency effects and higher share-based compensation.
Next month the United Nations Conference on Trade and Development (UNCTAD) will organise a meeting to discuss ways of encouraging the production of pharmaceutical in Africa.
The EMA and the US FDA will conduct parallel assessment of QbD development and manufacturing data for new drug submissions under a new pilot scheme announced this week.
World Street Fundamentals (WSF), the financial research specialist, has released two industry reports highlighting the mixed fortunes of biotech firms Biodel and MannKind, but claims a “brighter decade” lies ahead for the biotech sector.
Don’t think of the global regulatory information clampdown as a burden. It’s an opportunity to put your house in order, says Adam Sherlock, MD of ISI Europe.
Informed Medical Communications (IMC) a healthcare communications and training provider, has merged with training program designer and developer, IC Axon.
Leading players in the Japanese contract research sector have predicted ongoing disruption to trials in the aftermath of the massive earthquake and tsunami that struck the country last week.
US drug giant Pfizer may sell its generics, consumer health and Capsugel units in an effort to slim down and refocus on its core pharmaceutical business according to a number of reports.
