Pharmaceutical Technology Editors

The Grünenthal Group’s Tecnandina manufacturing plant in Ecuador has received the country’s first certification from the Regulatory Authority of Brazil.

Hovione will double its manufacturing capacity in New Jersey with an expanded facility and a commercial spray dryer designed to handle potent APIs.

The CDMO is striving to become a market leader in the development and manufacturing of antibody-drug conjugates.

Democratic members of the House Committee on Oversight and Government Reform are requesting a subpoena for documents withheld by Valeant Pharmaceuticals.

The agency releases guidance on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics.

Pharma development and manufacturing firm Patheon announces new tagline and logo.

The agency releases guidance on controlled correspondences related to generic-drug development.

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

Michael Kopcha has been named to lead CDER’s new Office of Pharmaceutical Quality.

MedImmune and 3M Drug Delivery Systems collaborate to develop toll-like receptor (TLR) agonists for immuno-oncology.

Stephen J. Ubl to succeed John J. Castellani as the next president and chief executive officer of PhRMA.

US Compounding, Inc. issues voluntary recall of all sterile products.

Cobra Biologics and the University of Manchester announce a collaboration to improve industrial scale-up of mammalian cell bioprocessing.

Winners from the seven categories will be announced live at the event in Madrid.

Six grants from the NIH will help identify variants in the genome’s regulatory regions that affect disease risk, using new computational approaches.

Novo Nordisk will build a local manufacturing plant for FlexPen prefilled insulin delivery devices in Iran.

ReposiTrak signs agreement to pilot track and trace system in pharma.

The company will showcase its range of drug packaging and delivery systems as well as launch a new ready-to-use validated packaging component.

Intuniv (guanfacine hydrochloride prolonged-release tablets) is the first selective alpha-2A adrenergic receptor agonist licensed for the treatment of attention deficit hyperactivity disorder in Europe.

Tomas Salmonson is re-elected as Chair of the Committee for Medicinal Products for Human Use.

Exports and domestic market have each been valued at more than US$15 billion.

IMA Active’s new tablet press machine, Prexima, is designed to deliver higher productivity and efficiency.

West Pharmaceutical Services and HealthPrize Technologies are collaborating on self-reporting and bar coding capabilities for injectable drug-delivery systems.

BASF is working together with top universities to develop a new supersonic spray-drying process for production of stable and soluble amorphous nanoparticles.

Piramal says pharmaceutical companies should strive to improve their processes, not just for original patented products but efforts should go beyond DMF and ANDA submissions.

Supersonic spray-drying process yields stable and soluble amorphous nanoparticles.

EMD Millipore, the Life Science business of Merck KGaA, introduced expanded documentation and regulatory information for its Emprove portfolio of pharmaceutical raw materials, which include excipients, process chemicals, and APIs.

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.

EDQM clarifies elemental impurities guidelines for veterinary and other products.

Nexvet Biopharma, a veterinary biologics developer, secured a dedicated, cGMP biologics manufacturing facility in Tullamore, Ireland, and plans to invest in disposable technology.