PTSM: Pharmaceutical Technology Sourcing and Management-10-07-2015

PTSM: Pharmaceutical Technology Sourcing and Management

FDA Plans Pilot Projects for Drug Supply Chain Security Act

October 02, 2015

Supply Chain

11

10

FDA selected USDM Life Sciences, RC Partners, and The Clarion Group to develop and implement a DSCSA pilot project.

Vetter Embarks on 300-Million Euro Manufacturing Expansion

October 01, 2015

Contract Services

11

10

Vetter plans to invest approximately 300 million Euros during the course of five years to expand drug product manufacturing and logistic services in Germany; upgrades will include an improved RABS system for aseptic processing.

Sterigenics International Adds Capacity

October 01, 2015

Contract Services

11

10

Sterigenics International will triple West Memphis sterilization capacity with $15 million expansion.

Tecnandina’s Ecuador Facility Receives ANVISA Certification

October 01, 2015

Contract Services

11

10

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

Hovione Expands Drug Substance Manufacturing

September 29, 2015

11

10

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

Piramal Introduces Proof of Concept Service for Next Wave of ADC Growth

September 29, 2015

Contract Services

11

10

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

Patheon Unveils New Brand Identity

September 28, 2015

Contract Services

11

10

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

FDA Releases Guidance on Generic-Drug Development

September 28, 2015

11

10

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

Kopcha Selected to Head FDA’s Quality Office

September 28, 2015

11

10

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

Cobra Biologics Announces Scale-Up Collaboration

September 24, 2015

Contract Services

11

10

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

ReposiTrak Announces Track and Trace Agreement

September 22, 2015

Supply Chain

11

10

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

Process Improves the Bioavailability of Active Ingredients

September 17, 2015

11

10

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

EMD Millipore Provides Risk-Assessment Information for Raw Materials

September 16, 2015

11

10

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.

FDA Cites India API Facility For CGMP Violations

September 16, 2015

11

10

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

FDA Issues Import Ban for Indian Drug Manufacturer

September 16, 2015

11

10

Polydrug Laboratories is issued a US import alert, following similar bans in Canada and Europe.

ISO/IEC Approves GS1 EPCIS Standard

September 15, 2015

Supply Chain

11

10

GS1 standard tracks movement and status of goods, enabling better visibility, security and regulatory compliance.

CMO Industry Growth Unsustainable According to Report

September 14, 2015

Outsourcing

11

10

PharmSource forecasts slow growth in a new report on the outlook for the contract manufacturing industry.

SGS Attains Biosafety Level 2 Compliance at Fairfield, NJ Facility

September 10, 2015

Contract Services

11

10

SGS Life Science Services announced that its facility in Fairfield, NJ, has been upgraded to be Biosafety Level 2 (BSL-2) compliant, according to the Centers for Disease Control and Prevention (CDC) guidelines.

United Cargo Adds Temperature-Controlled Units

September 01, 2015

Supply Chain

11

10

United Cargo signs global rental agreement with va-Q-tec for controlled transport of pharmaceuticals.