Reference Standards

LEBSA

Your strategic API source for niche molecules.

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DEVELOPMENT OF IMPURITIES

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Lebsa offers complete development of impurities, active pharmaceutical ingredients (APIs) and “building blocks”, 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

CPhI China 2023

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Recipharm AB

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

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Sweden

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Recipharm's specialities include preparation of reference standards & internal standards with stable isotopes, synthesis of complex heterocycles, sugars, steroids, ADC linkers, phosphates, etc.

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Category: API Development

Sub Category: Impurity / Reference Standard

asiaPLX 1 Singapore

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KriSan Biotech

International CDMO Expert in GMP Drug Substance, Oligonucleotide & Peptide Manufacturing.

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Taiwan

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IMPURITY REFERENCE STANDARDS

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KriSan Biotech offers research and process development services to prepare impurity reference standards, active pharmaceutical ingredients (APIs) and intermediates.

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Category: API Development

Sub Category: Impurity / Reference Standard

CPhI China 2023

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Maithili Life Sciences

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India

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SYNTHESIS & ISOLATION OF IMPURITIES

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Maithili undertakes the custom synthesis of key intermediates & active substances (APIs) for innovator companies worldwide. It has expertise in synthesizing diverse classes of molecules & offers gram to ton quantities in a cost-effective manner.

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Advinus Therapeutics Ltd

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India

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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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Category: API Development

Sub Category: Impurity / Reference Standard

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USP

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U.S.A

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REFERENCE STANDARDS FOR APIs

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USP offers primary standards to ensure quality in pharmaceutical development & manufacturing. USP reference standards are rigorously tested & evaluated by multiple independent laboratories including USP, commercial, regulatory & academic labs.

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UQUIFA

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Spain

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IMPURITY PROFILE CHARACTERIZATION

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Uquifa is a leading company for APIs and advanced intermediates offering capabilities including impurity profile characterization, stability studies, process validation and analytical method development services.

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Category: API Development

Sub Category: Impurity / Reference Standard

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Bioindustria L.I.M. Spa

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Italy

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DEGRADATION IMPURITIES

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Bioindustria L.I.M's R&D laboratories are in charge of synthesizing process and degradation impurities for analytical purposes and to support customers in developing generics.

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Category: API Development

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Solara Active Pharma Sciences

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India

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IMPURITY / REFERENCE STANDARD

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Solara has a synthetic development team dedicated to impurity synthesis, with more than 800 compounds available. Their analytical services include impurity marker & reference standard preparation, qualification, management & distribution.

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Maithili Life Sciences

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India

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IMPURITY, DEGRADANT OR METABOLITE ISOLATION

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Maithili undertakes the custom synthesis of key intermediates & active substances (APIs) for innovator companies worldwide. It has expertise in synthesizing diverse classes of molecules & offers gram to ton quantities in a cost-effective manner.

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TOPCHEM PHARMACEUTICALS

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Ireland

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IMPURITIES, METABOLITES & RELATED MATERIALS

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Topchem can supply impurity reference standards (IRS), metabolites and related research materials. Using their supply chain network they generally source advanced intermediates to facilitate rapid and cost effective supply of these materials.

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Priyans Drugs

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Singapore

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SYNTHESIS OF IMPURITIES & STANDARDS

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

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Category: API Development

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Aozeal Certified Standards

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U.S.A

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SYNTHESIS OF IMPURITIES & REFERENCE STANDARDS

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Aozeal Certified Standards (AOCS), Inc. is a high-tech biopharmaceutical company specialized in the custom synthesis & supply of API impurities & other pharmaceutical reference standards as per a customers’ desired purity, characterization & quantity.

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CLEARSYNTH LABS LIMITED

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India

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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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Category: API Development

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Eurofins CDMO

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France

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IMPURITY SYNTHESIS

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

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Kekule Pharma

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Looking for reference standards & impurity standards for APIs? Find a leading CMO, CDMO offering primary & secondary standards on PharmaCompass.