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API Development

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AMRI

Advinus Therapeutics Ltd

Almelo Private Limited

Anacipher

Bioindustria L.I.M. Spa

CLEARSYNTH LABS LIMITED

CU Chemie Uetikon GmbH

Cambrex Corporation

Catalent Pharma Solutions LLC

ChemCon GmbH

Dalton Pharma Services

Diverchim S.A.

Eurofins CDMO

GRAM Laboratory Inc

GVK Biosciences

M2I Life sciences

Maithili Life Sciences Private Limited

PHARMATHEN INDUSTRIAL SA

Priyans Drugs

SVAK Life Sciences

TOPCHEM PHARMACEUTICALS

UQUIFA

ZCL CHEMICALS LTD

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CANADA

FRANCE

GERMANY

GREECE

INDIA

IRELAND

ITALY

SINGAPORE

SPAIN

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.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

100% Export Oriented R&D Center & cGMP facility// Broad range of advance fine chemical intermediates & APIs

CPhI Worldwide

CPhI Worldwide

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- Service Details

State-of-the-art R&D center is located in our Ankleshwar facility. Highly qualified professionals with the scientific bent of mind are working in product development, analytical development and intellectual property rights.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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

CPhI Worldwide

CPhI Worldwide

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- Service Details

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

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

Streamline Drug Development - bring your Drug to Clinic Faster.

Nordic Life Science Days

Nordic Life Science Days

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- Service Details

Eurofins CDMO offers services during the whole development process and manage impurities synthesis and control.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

Chemistry for a better life

CPhI Korea Seoul

CPhI Korea Seoul

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- Service Details

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

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

- 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.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

- 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.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub 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.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

- 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

- 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.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

- 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

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

- 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

- Service Details

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

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

- 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 Development

Sub Category: Impurity / Reference Standard

- Service Details

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

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

- 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.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

- 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

- 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

- 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

- Service Details

Our team of experts can custom develop processes, design and optimize routes and provide R&D screening services using our proprietary library of more than 600 enzymes.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

- 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

- 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

- 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

- Service Details

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

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

- 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

- Service Details

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

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

- 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.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

- 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.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

- Service Details

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

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

- 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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