PTSM: Pharmaceutical Technology Sourcing and Management-08-05-2015

PTSM: Pharmaceutical Technology Sourcing and Management

BioOutsource Opens New Facility in Glasgow

July 31, 2015

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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

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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

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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

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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

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“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.

Xcelience Makes Investment in Powdersize

July 31, 2015

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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FDA Issues Quality Metrics Draft Guidance Document for Comment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

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FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.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

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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

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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

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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

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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

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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

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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

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The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

AMRI Acquires Gadea Pharmaceutical Group

July 16, 2015

Contract Services

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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

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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

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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

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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

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Charles Rivers strengthens its endotoxin testing and bacterial identification detection capabilities with the addition of Celsis’ products.