The pharmaceutical company has announced GMP-related challenges with a manufacturer contracted to fill syringes for Wegovy pens headed to the US market.
Growing need for validated storage capacity sees Lyophilization Services of New England complete an expansion its cGMP storage capabilities at its New Hampshire site.
The private equity firm Ampersand Capital has acquired Vibalogics with plans to increase development and manufacturing capabilities for complex viral products.
Upperton Pharma’s new and expanded facilities received a positive inspection from MHRA, enabling both research and development and clinical manufacturing at the site.
Almac announced it has increased its supply of neo-antigen peptides for individualized cancer treatments with the addition of another stream of GMP manufacturing.
PPD is adding nearly 6,000 square feet of new lab space – and about 20 employees – dedicated to gene and cell therapy analytical testing at its site in Athlone, Ireland.
Velesco Pharma has expanded its analytical research and development capabilities to meet a growing demand for its services after acquiring a new facility in Michigan.
With the US recognising Portugal’s ability to carry out GMP inspections, 15 countries are now part of the mutual recognition agreement between the EU and the US.
Kadam Exports Private has received a statement of non-compliance with GMP after the Danish Medicines Agency found manufacturing deficiencies at its facility in Gujarat.
Nova DFL’s dental adrenaline product has been denied marketing authorisation after French regulators raised seven critical deficiencies at its facility in Brazil.
Separate GMP rules for advanced therapies would put patients at risk according to the PIC/S, which has called on the European Commission (EC) to rethink the idea.
European regulatory authorities have reinstated the Good Manufacturing Practice (GMP) certificate at Ranbaxy Laboratories’ API manufacturing site in Toansa, India, which was suspended in January.
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.
There will be no major changes in the short term after the “surprise” decision by the EC to drop the directive about some excipients having to comply with GMP, according to a freelance consultant.
Pharmaceutical manufacturers in Vietnam have gained a reprieve
after the Ministry of Health (MoH) informed them that those without
good manufacturing practice (GMP) certificates can continue
production for now.
Nestec of Switzerland, a subsidiary of food giant Nestle, has been
awarded a US patent on a new way of producing the whey protein
glycomacropeptide (GMP) that could open up its use as an ingredient
in pharmaceuticals, dental compositions...