As propofol comes off its shortages list, the FDA says manufacturing problems still cause the majority of supply issues though legislation has helped to alleviate this.
The US FDA is allowing Fresenius Kabi USA to import trace elements and phosphate injections from its Norway plant to help improve a critical shortage of components of total parenteral nutrition (TPN).
Continued manufacturing issues at both American Regent and Hospira have caused the US FDA to begin allowing foreign imports as early as next week to combat a shortage of critical drugs for infants, the agency told us.
Injex says it is looking for partners to prefill its device and Glide will develop Pfenex’s anthrax vaccine using its solid-dose injector – welcome to our needle-free drug delivery round-up.
The FDA has finalised guidance on the manufacturing of antibiotics in order to prevent cross-contamination of finished pharmaceuticals and APIs with non-penicillin beta-lactam drugs.
Novaliq has raised funds to further development of its bioavailability boosting delivery technology and take its candidate dry eye drug into Phase I trials.
The US FDA has cleared Janssen to release one Lot of Doxil made using an unapproved manufacturing process at Ben Venue's plant to help alleviate shortages.
BD says a brand new facility and sustainable pricing will allow the company to compete as it enters the generics market following FDA approval of its first injectable drug.
The US FDA has waived normal pre-approval inspection requirements and cleared CMO Cook Pharmica to make an injectable drug that is currently in short supply.
A Canadian subsidiary of India’s largest CMO (contract manufacturing organization) was cited by the US FDA for failing to investigate rejected batches of product or implement further preventive actions.
Inspections in countries not expected to confirm API quality or seek exemption from new EU import regs “cannot be seen as a solution” to shortage concerns says the MHRA.
Aesica and EmulTech claim a new sterile formulation technology could help drugmakers resurrect abandoned projects and extend the lifespan of marketed medicines.
Impax Pharmaceuticals says it remains confident of resolving issues at its manufacturing facilities following the rejection of its Parkinson’s drug Rytary.
The drug industry is seeking more clarity on the descriptions of variations made to marketed drugs under the European Commission’s regulation governing the ways marketing authorizations can be re-classified.
The US FDA has finally adopted the revised ICH Q11 guidelines on drug substance manufacturing nearly six months after European regulators embraced the guidelines.
New Zealand regulator Medsafe and the Taiwan FDA will join the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) next year.
US CDMO DPT Labs has not done enough to investigate sterility failures observed during a March inspection according to the Food and Drug Administration (FDA) which wants a ‘comprehensive evaluation’ of sterile drug operations.
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.
Higher demand for clinical services drove growth at Catalent in fiscal Q4, offsetting falling European demand for injectables and flat oral delivery technology sales.
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.
Siegfried says lower raw materials costs helped its API business grow in the first half of 2012 and set out plans to expand manufacturing operations in China.
in-PharmaTechnologist.com presents its weekly round-up of the latest new faces and changing places in the world of pharmaceuticals, including news from AstraZeneca, Cresset and Aurobindo.
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.
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.
Bosch Packaging Technology says India is becoming one of its key markets, citing the growing pharma sector as a key driver for the development of its new Goa facility
