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PTSM: Pharmaceutical Technology Sourcing and Management-08-05-2015
PTSM: Pharmaceutical Technology Sourcing and Management
CDMOs Move Slowly with Expansion Plans
August 03, 2015
Outsourcing
11
8
Memories of tough economic times may discourage CDMOs from expanding capacity.
Accelerating Continuous API Synthesis
August 03, 2015
API Synthesis and Manufacturing
11
8
Early adopters look to speed up the use of continuous API manufacturing, but lack of expertise hinders adoption of continuous API synthesis.
BioOutsource Opens New Facility in Glasgow
July 31, 2015
11
8
The investment doubles the company’s capacity to meet increasing demand for its biologics contract testing and biosimilar characterization services.
Needle in the Haystack, or Rembrandt in the Attic? Drug Repurposing's New Strategy
July 31, 2015
API Synthesis and Manufacturing
11
8
Competitive pressures are driving more companies to repurpose APIs that had originally been developed for other indications. The industry has only "scratched the surface" of what might be possible, says consultant Hermann Mucke
Silicone Rubber Pieces Spur Recall of Teva Product
July 31, 2015
Regulatory
11
8
Teva Parenteral Medicines initiates voluntary nationwide recall of select lots of Adrucil due to particulate matter.
Baxter Recalls IV Solution for Container and Particulate Issues
July 31, 2015
11
8
Baxter has recalled of one lot of IV solution due to the potential for leaking containers, particulate matter, and missing port.
Indian API Manufacturer Cited for Recordkeeping Failures
July 31, 2015
API Synthesis and Manufacturing
11
8
“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.
Xcelience Makes Investment in Powdersize
July 31, 2015
11
8
Investment in Powdersize adds particle-size control solutions to Xcelience’s capabilities.
FDA Issues Quality Metrics Draft Guidance Document for Comment
July 28, 2015
Regulatory
11
8
FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.
EMA Issues Guideline on Fast Tracking Drugs for Unmet Needs
July 27, 2015
Regulatory
11
8
EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.
SafeBridge Updates Potent API and Drug Manufacturer Status
July 23, 2015
Supplier News
11
8
SafeBridge Consultants reports on the status of nine companies in the Potent Compound Safety Certification Program.
Capsugel Expands Capabilities at its Edinburgh Facility
July 23, 2015
Contract Services
11
8
Investment at Capsugel’s Edinburgh, Scotland facility will expand the company’s liquid- and semi-solid-fill capsule manufacturing capacity.
DPx Holdings Sells Fine Chemicals Business
July 22, 2015
Supplier News
11
8
Investment group Ardian will acquire the fine chemicals business activities of DPx Holdings B.V.
World Courier Receives UK Wholesale Distribution Authorisation
July 22, 2015
Supply Chain
11
8
World Courier receives pharmaceutical storage and transportation accreditation in the United Kingdom.
CSafe Adds Service Center for Controlled-Temperature Shipping in Switzerland
July 21, 2015
Supply Chain
11
8
CSafe and AES will support controlled-temperature shipping through the Basel, Switzerland airport from their new service center.
EMA Releases API Bioequivalence Studies Guidance
July 16, 2015
API Synthesis and Manufacturing
11
8
The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.
AMRI Acquires Gadea Pharmaceutical Group
July 16, 2015
Contract Services
11
8
AMRI expands its API portfolio and European presence through acquisition of Gadea’s Crystal Pharma Group.
EAG Acquires ABC Laboratories
July 16, 2015
Contract Services
11
8
Evans Analytical Group expands into the pharmaceutical/biopharmaceutical industry with acquisition of ABC Laboratories.
Vetter Introduces New Syringe Closure System for Highly-Sensitive Compounds
July 15, 2015
Contract Services
11
8
Consisting of a needle hub and a needle shield, the new syringe closure system is partly produced by means of a two-component injection molding process of polypropylene and thermoplastic elastomer.
DPT Enhances Flexibility and Efficiencies at San Antonio Facility
July 13, 2015
Contract Services
11
8
CDMO for semi-solid and liquid manufacturing realigns operations at Texas facility.
Charles River Acquires Celsis, Manufacturer of Rapid Microbial Detection Systems
July 09, 2015
Contract Services
11
8
Charles Rivers strengthens its endotoxin testing and bacterial identification detection capabilities with the addition of Celsis’ products.