Fercy Personal Care Products received an FDA warning letter after quality staff handed inspectors just two pages from a notebook as ingredient records.
Proposed EMA pharmacovigilance fees are too high and place a disproportionate burden on generics firms according to the European Generic Medicines Association (EGA).
Lundbeck has decided to stop making a cancer drug deeming the cost of securing API supplies too big and the likelihood to regulatory acceptance too small.
Pharmacopoeial standards authorities must cooperate to develop rigorous quality standards for drugs in an increasingly globalised market, according to the SFDA.
Since the publication of this article, in-PharmaTechnologist.com has been in touch with Health Canada to find out that the "updates" to the guidance document were actually to the font, not to the regulations. Health Canada launched no disclaimer...
The European Commission (EC) has made changes to its GMP guidelines in order to align them more closely with the pharmaceutical quality system described in ICH Q10.
US CMO Pharmaceutics International (Pii) has been named as the manufacturer of the cranial bleeding treatment voluntarily withdrawn by India’s Sun Pharmaceutical Industries earlier this week.
A new non-glycosolated protein production method using E.coli can cut manufacturing costs by up to 50 per cent as well as speeding up the process, according to researchers at the University of Arkansas.
The EC plan to extend drug GMP guidelines to APIs has met with a mixed response from industry groups, drugmakers and API manufacturers with some - like DSM and CEFIC – asking for clarification on the future of EudraLex Volume 4 Part II.
Hospira has bought Orchid Chemicals and Pharmaceutical’s active pharmaceutical ingredient (API) facility in Aurangabad, India, to support its expanding antibiotic business.
Drugmakers and importers are not complying with safety reporting requirements according to the Indian Drugs Controller General (DCG), which has given the offending firms three weeks to comply.
Ranbaxy has asked the US FDA to withdraw 27 ANDAs for products previously made at Indian manufacturing facilities hit with consent decree earlier this year.
The UN International Narcotics Control Board (INCB) says the diversion of pharmaceuticals at the national level has become one of the major sources of narcotics around the world.
From Usain Bolt’s lightspeed sprint double to Russell Brand’s brave but distinctly off-key mauling of the Beatles classic ‘I am the Walrus’ during the closing ceremony, the performances at the London 2012 Olympics were never less than spectacular.
Theorem and Gallus say their new biologics manufacturing partnership is aimed at giving a “leg up” to drugsmakers in emerging markets looking to market products in the US.
US biosecurity experts are calling on industry and the Government to “get a handle” on the supply chain for drugs used in times of pandemic or bio attack.
New Human Medicines Regulations came into effect this morning, overhauling the UK's regulations on drug manufacturing, importation, distribution, packaging and pharmacovigilance.
The US Food and Drug Administration backs pyrogen and endotoxin testing recommendations developed by the USP and AAMI, but has issued a Q&A to set out the regulatory perspective
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) wants members to suggest changes to tax laws governing pharmaceutical exports ahead of India’s next budget.
Biopharma manufacturers are putting their supply chains at risk by failing to prepare for emergencies, according to a new study by Best Practices, LLC.
Dr. Reddy’s may not have as big a hill to climb as some observers suggest to regain customers lost as a result of the closure of its Mexican API plant, according to Barclays.
The World Anti-doping Authority (WADA) wants pharmaceutical manufacturers to identify drug candidates in their pipelines that could be used to cheat in sport.
Pharmas producing drugs for the Australian market may see manufacturing licence charges slashed if their products do not sell above a certain threshold according to a plan outlined by the TGA.
Cherwell Laboratories has more than doubled the size of its Bicester, UK, plant that manufactures prepared media for microbial production after a boom in demand for its goods.
Four of the biggest pharma manufacturing associations are calling for more patient awareness of the burgeoning issue of fake drugs sold on the internet.
