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Product release testing, also known as lot or batch release testing is an important step in the quality control process of drug substances and drug products. This testing verifies that a pharmaceutical or biopharmaceutical product meets a pre-determined set of specifications. These often include verification of the formulation’s identity, potency and purity, impurities, uniformity, identity, presentation attributes, and sterility. Products that require Release Testing to meet GMP compliance are:

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AMRI

Admix Pharma Laboratories, LLC

Aenova Group

Ash Stevens, Inc.

Basic Pharma

Boston Analytical

CARBOGEN AMCIS AG

Cebiphar

ChemCon GmbH

Chromcore Lifesciences

DPT Laboratories, Ltd

Delorbis Pharmaceuticals LTD

GVK Biosciences

Jubilant HollisterStier

KriSan Biotech

Megsan Labs Private Limited

Mithra CDMO

ORIT LABS LLC

PYRAMID Laboratories, Inc

Pace Analytical Services, LLC

Pharmathen SA

QUINTA-ANALYTICA s.r.o

Quantex Laboratories

ScinoPharm Taiwan, Ltd

Stason Pharmaceuticals, Inc.

Tepnel Pharma Services

Vitas Analytical Services

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CZECH REPUBLIC

FRANCE

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TAIWAN

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UNITED STATES

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AMRI offers customized stability testing that includes developmental and packaging studies, stability protocol design, chromatographic analysis, wet chemistry and dissolution testing.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

Virtual BoothA leading process R&D and API Manufacturing service provider to the Global Pharmaceutical Industry.

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ScinoPharm's comprehensive analytical services include purity testing, characterization of polymorphs, analytic methods development & validation, & stability testing. All analytical instruments & data are managed through the company's LIMS.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

Virtual BoothProviding Life Cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Pharmathen’s offers cGMP Quality Control (QC) testing for excipients, intermediates, raw materials, APIs and GMP batch release testing for drug products supporting pharmaceutical development and manufacturing.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

Virtual BoothGlobal provider of comprehensive top services in the field of Drug Testing, Clinical Trials & Bioanalytical Services.

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Quinta-Analytica is a well-known and established company performing so called „import testing“. This is a testing of a batch manufactured outside EU which is planned for import and release within European market.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Tepnel is a QC testing laboratory that provides batch release & lot release testing. They have a wealth of experience across a wide range of small molecule, inhalation drug products & biopharmaceutical product types in accordance with the requirements

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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AMRI provides the resources and flexibility to develop and improve analytical methods tailored to your specific needs.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

Virtual BoothProviding Life Cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Pharmathen’s offers cGMP Quality Control (QC) testing for excipients, intermediates, raw materials, APIs and GMP batch release testing for drug products supporting pharmaceutical development and manufacturing.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Quantex Laboratories supports your product Quality Control and Release Testing needs for Active Ingredients intermediates, excipients and finished products. We have experience testing for many types of formulations.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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With a nationwide network of 29 environmental laboratories, 3 life sciences labs, 2 LabOps locations, and 46 service centers, Pace Analytical offers compendia (USP, EP, JP) methods of analytical services for qualitative and quantitative assessment of raw materials, APIs and Finished Products.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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With Admix Pharma Laboratories, LLC you will enjoy a host of attractive benefits that can effectively extend your in-house pharmaceutical products development and manufacturing capabilities for long and short term projects.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

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- Service Details

Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing