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API Development
AMRI
Advinus Therapeutics Ltd
Almelo Private Limited
Anacipher
Bioindustria L.I.M. Spa
CLEARSYNTH LABS LIMITED
CU Chemie Uetikon GmbH
Catalent Pharma Solutions
ChemCon GmbH
Dalton Pharma Services
Diverchim S.A.
Eurofins CDMO
Evotec
GRAM Laboratory Inc
GVK Biosciences
LEBSA
M2I Life sciences
Maithili Life Sciences Private Limited
Pharmathen SA
Priyans Drugs
Recipharm AB
SVAK Life Sciences
Sai Life Sciences Limited
Solara Active Pharma Sciences
TOPCHEM PHARMACEUTICALS
UQUIFA
Wavelength Pharmaceuticals
ZCL CHEMICALS LTD
CANADA
FRANCE
GERMANY
GREECE
INDIA
IRELAND
ISRAEL
ITALY
SINGAPORE
SPAIN
SWEDEN
UNITED STATES
Production of small & large volume I.V. Solutions// Generic Drug Products// APIs// GMP certified.
- Service Details
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 DevelopmentSub Category: Impurity / Reference Standard
- Service Details
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 DevelopmentSub Category: Impurity / Reference Standard
A partner for the pharma and biotech industries to improve patient outcomes & quality of life
- Service Details
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 DevelopmentSub Category: Impurity / Reference Standard
Your partner in APIs Manufacturing since 1951.
- Service Details
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 DevelopmentSub Category: Impurity / Reference Standard
Brightest Minds in the CDMO industry - From early Development to Commercial Manufacturing
- Service Details
Recipharm's specialities include synthesis of complex heterocycles, sugars, steroids, ADC linkers, phosphates, preparation of reference standards & internal standards with stable isotopes.
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Pharma Service: API & Drug Product Development
Category: API DevelopmentSub Category: Impurity / Reference Standard
World-Class Developer & Manufacturer of Differentiated APIs// in 50 countries// 198 DMFs Worldwide.
- Service Details
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
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Pharma Service: API & Drug Product Development
Category: API DevelopmentSub Category: Impurity / Reference Standard
- Service Details
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 DevelopmentSub Category: Impurity / Reference Standard
- Service Details
Uquifa offers the opportunity to manage development activities of any drug life cycle by offering contract services on DMF/CTD/COS application, working standard & impurity supply, stability studies, process validation and analytical method services.
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Pharma Service: API & Drug Product Development
Category: API DevelopmentSub Category: Impurity / Reference Standard
API Expertise for more than 30 Years, with 4 Manufacturing Facilities armed with Global Approvals.
- Service Details
Solara's synthetic development has dedicated team for Impurity synthesis more than library 800 compounds available.
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Pharma Service: API & Drug Product Development
Category: API DevelopmentSub Category: Impurity / Reference Standard
- Service Details
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 DevelopmentSub Category: Impurity / Reference Standard
- Service Details
The key services offered by Sai Life Sciences include synthesis of reference compounds, lead generation and optimization, preparation of building blocks/key intermediates, metabolites, and impurity markers, etc.
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Pharma Service: API & Drug Product Development
Category: API DevelopmentSub Category: Impurity / Reference Standard
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- Service Details
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 DevelopmentSub Category: Impurity / Reference Standard
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- Service Details
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 DevelopmentSub Category: Impurity / Reference Standard
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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.
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Pharma Service: API & Drug Product Development
Category: API DevelopmentSub Category: Impurity / Reference Standard
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- Service Details
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 DevelopmentSub Category: Impurity / Reference Standard
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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 DevelopmentSub Category: Impurity / Reference Standard
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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.
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Pharma Service: API & Drug Product Development
Category: API DevelopmentSub Category: Impurity / Reference Standard
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- Service Details
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 DevelopmentSub Category: Impurity / Reference Standard
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- Service Details
Priyans Drugs headquartered in Singapore, is a professionally managed company supporting the pharmaceuticals business globally.
- Directory Listing
Pharma Service: API & Drug Product Development
Category: API DevelopmentSub Category: Impurity / Reference Standard
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- Service Details
Uetikon offers an extensive expertise to its pharmaceutical and biotechnology partners.
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Pharma Service: API & Drug Product Development
Category: API DevelopmentSub Category: Impurity / Reference Standard
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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 DevelopmentSub Category: Impurity / Reference Standard
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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 DevelopmentSub Category: Impurity / Reference Standard
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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 DevelopmentSub Category: Impurity / Reference Standard
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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.
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Pharma Service: API & Drug Product Development
Category: API DevelopmentSub Category: Impurity / Reference Standard
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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).
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Pharma Service: API & Drug Product Development
Category: API DevelopmentSub Category: Impurity / Reference Standard
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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.
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Pharma Service: API & Drug Product Development
Category: API DevelopmentSub Category: Impurity / Reference Standard
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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.
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Pharma Service: API & Drug Product Development
Category: API DevelopmentSub Category: Impurity / Reference Standard
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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 DevelopmentSub Category: Impurity / Reference Standard
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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.
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Pharma Service: API & Drug Product Development
Category: API DevelopmentSub Category: Impurity / Reference Standard
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- Service Details
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 DevelopmentSub Category: Impurity / Reference Standard
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- Service Details
Evotec support the key steps of the development of our partner’s API in Route scouting & identification of a new route, Custom synthesis, Analytical method development & validation, Synthesis of reference standards and impurity.
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Pharma Service: API & Drug Product Development
Category: API DevelopmentSub Category: Impurity / Reference Standard
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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 DevelopmentSub Category: Impurity / Reference Standard
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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 DevelopmentSub Category: Impurity / Reference Standard
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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 DevelopmentSub Category: Impurity / Reference Standard
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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 DevelopmentSub Category: Impurity / Reference Standard
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