Pharma companies have improved or maintained standards for effective drug recalls, product packaging and managing supply in LMICs, according to the report.
As negotiations continue and discussions on ‘hard Brexit’ outcomes build, few have considered the impact on European industry, one organisation suggests.
The US FDA has issued a warning letter to contract testing laboratory Pharmaceutical Laboratories and Consultants, Inc., after a microbrewery was found to be operating in shared space.
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.
The US FDA has sent a warning letter to Tris Pharma, a New Jersey-based manufacturer that makes ADHD drug Quillivant XR (methylphenidate HCl) for Pfizer.
The US FDA has issued complete response letters (CRL) for the Rituxan and Herceptin biosimilar candidates after Celltrion’s facility received a warning in Janaury.
Porton Biopharma will look to develop GMP manufacturing capabilities for Clostridia bacteria as part of a UK collaboration developing aimed at developing microbiome targeted therapeutics.
IPEC Federation and PDA will publish a technical report in 2019 to provide drugmakers guidelines on how to implement risk assessment challenges of excipient supply.
The US FDA warnings sent to Chinese and Hong Kong-based firms are the latest examples of OTC makers struggling to comply with pharmaceutical standard GMP.
Indena says industry’s recognition of the high quality of Italian-made ingredients has driven investments in an HPAPI kilolab and a multi-purpose pilot plant near Milan.
Increased enforcement of cGMP on over-the-counter (OTC) drugs is highlighting the grey-area in classification with cosmetic products, a former FDA director says.
The detection of cracks of the surface of glass vials has prompted a voluntary recall of Labetalol Hydrochloride Injection made at Pfizer’s troubled McPherson, Kansas facility.
AstraZeneca says its hyperkalaemia candidate ZS-9 is back on track for approval after manufacturing issues at its Texas facility resulted in regulatory delays.
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.
Amneal Pharmaceuticals expects to bring production of some Impax Laboratories’ drugs in-house through a 100,000 sq. ft. expansion at its site in New York state.
Semler Research Center says the US FDA caused the “complete annihilation” of its business after regulators rejected bioanalytical studies on the back of data integrity concerns.
Rephine says its online Quality Assurance database transforms the lengthy active pharmaceutical ingredient (API) pre-selection process to just a couple of clicks.
The US FDA has asked Braeburn Pharmaceuticals for more information regarding its sustained-release subcutaneous buprenorphine injection in a complete response letter (CRL).
Apotex has recalled a batch its diabetes drug APO-Metformin XR in Australia after a pill was plastic from a cable or zip tie was found embedded in a pill.
Pfizer says ongoing remediation to the quality validation process at its supplier has resulted in a shortage of EpiPen auto-injectors in the 0.3 mg format.