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GMP process development and API manufacturing

For a seamless transition from laboratory-scale synthesis and technical batches
to GMP-compliant API manufacturing
read more


find out more


CHEMCON IS NOW 25 YEARS OLD!

an exclusive interview with Dr. Raphael Vogler (Founder & CEO)

to the interview

Big Ideas for small to medium volumes

Welcome to ChemCon!

Your direct laboratory contact for chemical contract synthesis and quality
control.


Chemical testing lab

Your partner laboratory for quality control according to ICH guidelines, GMP
method validation and release analysis, impurity determination, references
standards, ...

find out more

GMP process development and API manufacturing

For a seamless transition from laboratory-scale synthesis and technical batches
to GMP-compliant API manufacturing
read more


find out more


CHEMCON IS NOW 25 YEARS OLD!

an exclusive interview with Dr. Raphael Vogler (Founder & CEO)

to the interview

Big Ideas for small to medium volumes

Welcome to ChemCon!

Your direct laboratory contact for chemical contract synthesis and quality
control.


Chemical testing lab

Your partner laboratory for quality control according to ICH guidelines, GMP
method validation and release analysis, impurity determination, references
standards, ...

find out more

GMP process development and API manufacturing

For a seamless transition from laboratory-scale synthesis and technical batches
to GMP-compliant API manufacturing
read more


find out more


GMP CHEMICAL SERVICES


SYNTHESIS AND ANALYSIS OF PHARMACEUTICAL INGREDIENTS AND FINE CHEMICALS

--------------------------------------------------------------------------------

Contract Development & Manufacturing

Analytical Services

Products

Quality & Regulatory


QUALITY MADE IN GERMANY


YOUR RELIABLE PARTNER LABORATORY

--------------------------------------------------------------------------------

In ChemCon you will find an internationally operating partner for the synthesis
and analysis of pharmaceutical ingredients (APIs, GMP) and fine chemicals.

You are spot-on, if you are looking for a chemical substance (organic,
inorganic, polymeric) in small to medium quantities. Examples are active
pharmaceutical ingredients (APIs) in preclinical and clinical studies or for
commercial chemical and pharmaceutical application.

ChemCon’s analytics team takes care of your inquiries if you are looking for
ICH-compliant quality control, GMP validation, release analysis, impurity
determination, reference standards or answers to other analytical queries.

On top of our chemical services, you will also find selected products in
ChemCon’s portfolio.

Quality assurance and regulatory consulting completes comprehensive
GMP-compliant production and analysis, validation and documentation.


CONTRACT DEVELOPMENT AND MANUFACTURING ORGANIZATION (CDMO)

Customized synthesis and process development
Organic and inorganic chemistry
Polymer Chemistry
Technical batches and GMP pilot batches
Active substances for clinical studies
Fine Chemicals
Cytotoxic, highly potent or BtMG regulated compounds
Close communication with chemists and process engineers




Chemical Expertise


SMALL BUT IMPORTANT? KILOLAB SERVICES AVAILABE FOR COMMERCIAL SUPPLY


COMMERCIAL CONTRACT MANUFACTURING

--------------------------------------------------------------------------------

We enable commercial routine production for an annual requirement of < 100 g to
several 100 kg.

Your pharmaceutical ingredients are produced to GMP guidelines and your
specifications for application in injectable, ophthalmic, oral, or topic
formulations.

GMP production (APIs)

We also produce chemicals, starting materials, or reference standards upon
inquiry. Our analytics team takes care of qualification and release for you.

Chemical production


CHEMICAL TESTING SERVICES

Chemical characterization
Quality control
Impurity determination
Method development and validation
Release analysis
Stability studies
Reference standards

Close, outcome-oriented communication: We also work with you on challenges,
where routine testing is not sufficient.

What we can do for you


QUALITY CONFIRMED BY FDA AND GERMAN AUTHORITIES


AUDITS AND GMP INSPECTIONS

--------------------------------------------------------------------------------

Since founding in 1997, ChemCon has been audited over 200 times, to the full
satisfaction of the customers. We are looking back onto a long list of
successful GMP inspections, most recently 2018 by the FDA (US Food and Drug
Administration) and 2019 by German authorities (Regierungspräsidium Tübingen, EU
GMP)

 

Inspection History

ABOUT CHEMCON

NEWS & EVENTS

--------------------------------------------------------------------------------

Filter aktiv

News
07/28/2022


PRESS RELEASE: FIRE AT CHEMCON GMBH

Fire in R&D Laboratory

Read more
Events
07/22/2022


CHEMCON AT CPHI WORLDWIDE 2022

November 01-03, 2022 Messe Frankfurt, Germany

Booth 121B71, zone API

Read more
Events
07/22/2022


CPHI KOREA 2022

28-30 September, COEX, Seoul

Booth # J28

ChemCon is thrilled to be back in Korea to meet new and old business contacts

Read more
Events
05/10/2022


BIO INTERNATIONAL, JUNE 13-16, SAN DIEGO

Meet ChemCon at the BIO International

Read more

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Germany

Tel. +49 761 5597-0
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info@chemcon.com

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