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AMRI

Advinus Therapeutics Ltd

Almelo Private Limited

Anacipher

Bioindustria L.I.M. Spa

CLEARSYNTH LABS LIMITED

CU Chemie Uetikon GmbH

Catalent Pharma Solutions LLC

ChemCon GmbH

Dalton Pharma Services

Diverchim S.A.

Eurofins CDMO

GRAM Laboratory Inc

GVK Biosciences

LEBSA

M2I Life sciences

Maithili Life Sciences Private Limited

PHARMATHEN INDUSTRIAL SA

Priyans Drugs

SVAK Life Sciences

TOPCHEM PHARMACEUTICALS

UQUIFA

Wavelength Pharmaceuticals

ZCL CHEMICALS LTD

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Virtual BoothProduction of small & large volume I.V. Solutions// Generic Drug Products// APIs// GMP certified.

Degradation Impurities

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Biondustria L.I.M's R&D Laboratories are in charge of synthesizing process and degradation impurities for analytical department and to support customers in developing their generics.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

Virtual Booth100% Export Oriented R&D Center & cGMP facility// Broad range of advance fine chemical intermediates & APIs

Synthesizing Impurities

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Our highly qualified professionals are working in product development, analytical development & IP rights. Our activities include Route Scouting, Process Development, Scale up, Technology Transfer, Synthesizing Impurities, Contract Research etc

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

Virtual BoothA partner for the pharma and biotech industries to improve patient outcomes & quality of life

Impurity Isolation and Identification

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AMRI's scientists apply LC/MS as a profiling technique to systematically monitor process-related impurities and degradants.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

Virtual BoothYour partner in APIs Manufacturing since 1951.

Complete Development of Impurities

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Complete development of APIs, “building blocks” and impurities, in cooperation with and supervised by the interested party.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

Virtual BoothWorld-Class Developer & Manufacturer of Differentiated APIs// in 50 countries// 198 DMFs Worldwide.

Synthesis of Impurities & Reference Standards

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We support your API development & manufacturing requirements. Our CDMO Services include technology transfer, process development, analytical methods development, synthesis of impurities & standards, potential genotoxic impurities evaluation etc

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

Virtual BoothStreamline Drug Development - bring your Drug to Clinic Faster.

Impurity Synthesis

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Eurofins CDMO identifies, isolates & synthesizes process related impurities to support process development, analytical control & regulatory requirements. We offer services during the whole development process & manage impurities synthesis & control.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

Virtual BoothChemistry for a better life

Impurity Profile Characterisation

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Uquifa offers the opportunity to manage the development activities of any drug life cycle by offering services on DMF/CTD/COS application, stability studies, process validation and analytical method validation, working standard supply or impurity

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Impurity Identification

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Catalent offers fully-validated, GMP Nuclear Magnetic Resonance (NMR) and Mass Spectrometric (MS) services, as well as other spectroscopic and thermal techniques for impurity identification.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Synthesis/Isolation of Impurities, Metabolite...

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Maithili undertakes custom synthesis of key intermediates and active substances for innovator companies worldwide. We have the expertise in synthesizing diverse classes of molecules and offer gram to ton quantities in a cost-effective manner.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Control of Impurities

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Pharmathen’s R&D activities have been vertically intergraded including Research and Development of Active Pharmaceutical Ingredients (APIs). Both labs are outfitted with the most technologically advanced and state of the art instrumentation and equipment.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Metabolite And Impurity Synthesis

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Advinus offers a full range of chemistry services spanning miligram scale synthesis for efficacy and toxicology studies, to multi kilogram scale cGMP scale-up for early clinical development.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Reference Standard Characterization

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Catalent offers fully-validated, GMP Nuclear Magnetic Resonance (NMR) and Mass Spectrometric (MS) services, as well as other spectroscopic and thermal techniques for reference standard characterization.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Impurities, Degradants or Metabolites Isolati...

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- Service Details

Maithili undertakes custom synthesis of key intermediates and active substances for innovator companies worldwide. We have the expertise in synthesizing diverse classes of molecules and offer gram to ton quantities in a cost-effective manner.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Impurities, Metabolites & Related Research Ma...

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- Service Details

Building on our experience of API development we can supply reference standard impurities, metabolites and related research materials. Using our supply chain network we generally source advanced intermediates to facilitate rapid and cost effective supply of these materials

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Synthesis of Impurities & Standards

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- Service Details

Priyans Drugs headquartered in Singapore, is a professionally managed company supporting the pharmaceuticals business globally.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Related Compounds & Potential Impurities

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Clearsynth services are applied at all stages of development. Clearsynth considers all issues related to compounds and potential impurities.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Synthesis of Impurities & Samples

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Uetikon offers an extensive expertise to its pharmaceutical and biotechnology partners.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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API Reference Standard Qualification

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- Service Details

GRAM Laboratories provides services geared towards qualification of an active pharmaceutical ingredient, through monograph testing, compendial and vendor method verification, qualification of impurity profile and reference standard qualification.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Synthesis of GMP Impurities

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- Service Details

Maithili undertakes custom synthesis of key intermediates and active substances for innovator companies worldwide. We have the expertise in synthesizing diverse classes of molecules and offer gram to ton quantities in a cost-effective manner.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Synthesis of Known / Unknown Impurities

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- Service Details

With the help of deep Organic Chemistry knowledge along with state-of-the-art synthesis infrastructure, we offer synthesis services for known / unknown impurities.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Reference Standards/Working Standards of Impu...

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- Service Details

Reference standards / working standards of impurities and products can be qualified and characterized with the complete report for regulatory submission. We help in in-house impurity standard generation by means of Degradation and isolation or synthesis.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Developing Analytical References & Impurities

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- Service Details

M2i coveres all needs from a few milligrams (leads, analytical references, impurities, etc.) to several kilograms (kilolab batches) thanks to its multipurpose equipment (reactors ranging from 250 mL to 50 L, temperature range from -40 °C to +165 °C).

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Reference Standards

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- Service Details

Our team of experienced Scientists has expertise in the custom synthesis of a wide range of small molecules like API, stable isotope labeled compounds, chemical intermediates, drug metabolites, drug analogs, analytical standards, reference standards, pharmaceutical impurities.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Pharmaceutical Impurities

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- Service Details

Our team of experienced Scientists has expertise in the custom synthesis of a wide range of small molecules like API, stable isotope labeled compounds, chemical intermediates, drug metabolites, drug analogs, analytical standards, reference standards, pharmaceutical impurities.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Impurities Standards Supply

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- Service Details

DIVERCHIM can supply its customer impurities standards, in response to the Health Agencies’ requirements for impurities definition and characterization.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Impurity Reference Standards

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- Service Details

We handle Process development Projects, Cost reduction Projects and Impurity standards worldwide to a client base that includes pharmaceutical, manufacturers of specialty chemicals, as well as to universities and various other research institutions.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Impurity Synthesis

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The Almelo Research Center (ARC) is a fully established facility for our in-house and custom product R&D services.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Impurity Identification, Characterisation & S...

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- Service Details

GVK BIO offers an extensive Process R&D support, designed to address the issues involving both scientific and communication challenges. We are cognizant of the need for customisation as per client’s need.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Synthesis of Impurities

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- Service Details

Chemcon's experience with pharmaceutical requirements and our broad chemical knowledge of small organic molecules, inorganic substances, and polymers allow our analytical team to collaborate with you on tailor-made solutions and analytical packages.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Impurity Screening

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- Service Details

Identification of Unknown impurities of >0.05% abundance using internally developed or client supplied method.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Impurity Reference Standards

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- Service Details

Identified compounds can be ultra-purified for use as reference standards for QC analysis and stability impurity monitoring studies.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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