Trading and import of pharmaceutical active ingredients (APIs) with temperature-controlled storage and GDP-compliant processes

Andenex-Chemie Engelhard + Partner GmbH

HamburgNew on Amplifa

HRB 25784, Amtsgericht HamburgCommercial Register

Hamburg, Albert-Einstein-Ring 11Location

GmbHLegal Form

About Andenex

Andenex-Chemie Engelhard + Partner GmbH is a trading company focused on pharmaceutical active ingredients (APIs), headquartered in Hamburg. The company connects active ingredient manufacturers with pharmaceutical companies and supports the import and distribution of the active ingredients. Its services include temperature-controlled and monitored storage, transport management, quality and quality risk management, deviation control (change control) and CAPA measures, complemented by regulatory expertise. According to its own statements, the company has been in business since 1980; it sees itself as a Hanseatic merchant with a focus on consistent, safe and economical handling. Andenex is registered in the EudraGMDP database as an importer/distributor of APIs (registration DE_HH_01_Reg_2018_0065, first registered in 2018, confirmed in 2023) and holds a GDP conformity certificate under EU guideline 2015/C95/01, which is monitored by MediConZert as part of the ISO-9001 certification.

Site: Hamburg
Processes: Trading/distribution of pharmaceutical active ingredients (APIs), Import of active ingredients, Temperature-controlled and monitored storage, Quality management and quality risk management, Transport management, Regulatory expertise
Materials: Pharmaceutical active ingredients (APIs)
Certificates: GDP conformity (EU guideline 2015/C95/01), ISO 9001:2015 (certificate not itself enclosed, GDP tied to it), ISO 9001:2015 (GDP conformity tied to it), GDP conformity EU 2015/C95/01
Industries: Pharmaceutical industry, Active ingredient trading, Pharmaceutical manufacturers (human and veterinary medicines)

01
Import of active ingredients (APIs)
02
Temperature-controlled and monitored storage
03
Quality management and quality risk management
04
Transport management
05
Distribution to pharmaceutical companies

Services and Processes

API

Pharmaceutical active ingredients (APIs)

Import and distribution of active ingredients for human medicines; the registered activity covers the import and trading of APIs.

Locations

Hamburg

Trading and warehouse: import and distribution of APIs, temperature-controlled and monitored storage

Materials: Pharmaceutical active ingredients (APIs)

Temperature-controlled and monitored storage

Inside the production

Industries

Pharmaceutical industryActive ingredient tradingPharmaceutical manufacturers (human and veterinary medicines)

Additional services

Trading/distribution of pharmaceutical active ingredients (APIs)Import of active ingredientsTemperature-controlled and monitored storageQuality management and quality risk managementTransport managementRegulatory expertise

Quality and Certificates

Andenex follows the Good Distribution Practices of the EU guideline 2015/C95/01 and is registered in the EudraGMDP database. GDP conformity (KBS-Nr. 226.1-R2-GDP, MediConZert) is monitored annually through repeat audits and is tied to the ISO-9001:2015 certification.

Evidence	Hamburg
ISO 9001:2015 (GDP conformity tied to it)
GDP conformity EU 2015/C95/01

History

1980
Company activities in active ingredient trading: "At the centre of trade since 1980"
2018
EudraGMDP registration as importer/distributor of APIs (DE_HH_01_Reg_2018_0065, 2018-10-18)
2023
GDP audit by MediConZert (5.12.2023) with certificate of conformity dated 20.12.2023; EudraGMDP registration confirmed (2023-04-13)