Recipharm AB

Brightest Minds in the CDMO industry - From early Development to Commercial Manufacturing

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IMPURITY IDENTIFICATION

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Recipharm has extensive experience and a range of analytical and synthetic equipment to conduct successful impurity identification in pharmaceutical products.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Impurity Isolation and Identification

CPhI Worldwide 2022

Booth # 90J30

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West pharma services

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EXTRACTABLES & LEACHABLES TESTING FOR DELIVERY SYSTEMS

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West offers extractables/leachables analysis for packaging and delivery systems for all pharmaceutical and biological products.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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Primera Analytical Solutions Corp

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U.S.A

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ASSESSMENT OF LEACHABLES & EXTRACTABLES IN DRUG PRODUCT...

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Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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mKnal Global Solutions

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India

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EXTRACTABLE & LEACHABLE STUDIES

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Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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Quantex Laboratories

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U.S.A

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ASSESSMENT OF LEACHABLES & EXTRACTABLES IN DRUG PRODUCT...

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Our scientists conduct extractables and leachables studies in accordance with Good Manufacturing Practices (GMPs) ,PQRI recommendations, United States Pharmacopeia (USP) requirements.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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Vitas Analytical Services

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Norway

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ASSESSMENT OF LEACHABLES & EXTRACTABLES IN DRUG PRODUCT...

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Our extractables and leachables analytical services include: Modify and validate controlled extractable methods for testing and profiling of leachables and Develop HPLC, GC, and MS methods for controlled extractables from pharmaceutical containers, closures and devices.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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Crenza Pharma

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India

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EXTRACTABLE & LEACHABLE STUDY

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Crenza is a full scale R&D centre for development of Parenteral and Ophthalmic drug products. Crenza is founded by Industry professionals with invaluable experience and proven track record of development and commercialization of Parenteral and Ophthalmic drug products for regulated markets.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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Unither Pharmaceuticals

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France

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EXTRACTABLES & LEACHABLES ANALYSIS

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Unither analytical services include method development & validation, analytical method transfer & ICH stability studies. They provide extractable & leachable closure system compatibility studies, unknown substance identification & characterization etc.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Impurity Isolation and Identification

CPhI Worldwide 2022

Booth # 90A50

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Anacipher

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India

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GENOTOXIC EVALUATION

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Genotoxicity of the impurity can be evaluated based on FDA approved software. It offers genotoxic and Potential extractable and leachables studies and stablishment of Specification and acceptance criteria

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Toxicological Risk Assessment (TRA)

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Anacipher

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India

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EXTRACTABLE & LEACHABLES

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Extractable and Leachables (both organic and inorganic) study in drug product. It offers development and validation of analytical methods, study stability sample for establishment of leachables maximum level, and qualification of extractable and leachables.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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Saneca Pharmaceuticals

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Slovakia

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SYNTHESISING & CHARACTERISING IMPURITIES

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At Saneca Pharma, we offer a range of generic API development services including route of synthesis optimisation. Our API development & manufacturing facilities use the same equipment to take your project from pilot to commercial scale production.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Impurity Isolation and Identification

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Curida AS

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Norway

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PHYSICAL & PHYSIO-CHEMICAL DETERMINATIONS

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Physical and physio-chemical determinations (e.g. pH,nconductivity, viscosity, melting point, refractometer, polarimeter, sub-visible particle counter, osmolality, loss on drying)

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Chemical Characterization

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Boston Analytical

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U.S.A

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EXTRACTABLES & LEACHABLES ANALYSIS

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Boston Analytical's staff has experience evaluating Extractables & Leachables in pharmaceutical packaging, medical devices, drug-delivery/combination products, processing equipment, Single Use Systems, e-cigarettes, and consumer product packaging.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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GRAM Laboratory Inc

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U.S.A

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EXTRACTABLES & LEACHABLES STUDY

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GRAM Laboratories offers development of a clinically relevant and more stable formulation. This is made possible because of the knowledge gained from preformulation evaluation. Formulation studies are customized to achieve the most appropriate formulation in a timely and cost efficient manner.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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Aizant Drug Research Solutions Pvt. Ltd.

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India

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LEACHABLES & EXTRACTABLES STUDIES

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Analytical research and development (AR&D) offers standalone services and supports our formulation development activities.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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Solvias

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Switzerland

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EXTRACTABLE & LEACHABLE TESTING SERVICES

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Solvias provides expert testing and consulting services to assess the safety and integrity of extractables and leachables in pharmaceuticals by providing customizable workflow for quantitative extractables studies.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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DPT Laboratories, Ltd

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U.S.A

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EXTRACTABLE & LEACHABLES

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DPT’s provides reliable and accurate analytical testing services for Extractable & Leachables.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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Megsan Labs Private Limited

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India

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EXTRACTABLE & LEACHABLE STUDIES

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Megsan Labs is an USFDA inspected leading analytical testing laboratory, we focused and committed to deliver testing services to our costumers with excellence in quality, compliance and promptness

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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Sartorius Stedim Biotech

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Germany

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EXTRACTABLES & LEACHABLES TESTING SERVICES

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Sartorius offers unique expertise in the field of extractables & leachables, such as extractables evaluation, extractables & safety assessments, E&L long-term/storage studies for different container materials, leachables screening, etc.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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Pace Analytical Services, LLC

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U.S.A

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EXTRACTABLE & LEACHABLE 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: Extractables and Leachables

Sub Category: Testing Services

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Doctor's Analytical Laboratories

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India

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EXTRACTABLE & LEACHABLES TESTING SERVICES

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DALPL's current services at the pharma division include extractable & leachables as per FDA guidelines & PQRI suggestions, genotoxic impurity [nitrosamine impurities] quantification studies, carryover impurity studies, elemental impurities by ICP MS, etc.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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Cambrex Corporation

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U.S.A

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CHEMICAL CHARACTERIZATION

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We offer Integrating Capabilities of Building product safety into process design under one roof, which can facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitgating risks associated with the final product.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Chemical Characterization

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DPT Laboratories, Ltd

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U.S.A

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