Trading in well-documented pharmaceutical active ingredients (APIs) and excipients, including GDP-certified storage and distribution.
F. & A. PHARMA-Handels-GmbH
Dorsten (Registered Office) · Reken (Corporate Office, GDP-/ISO-certified warehouse)New on Amplifa
About F. & A. PHARMA
F. & A. PHARMA-Handels-GmbH is a pharmaceutical service provider based in Dorsten with a GDP- and ISO-certified warehouse in Reken. Its core business is the trade in well-documented active ingredients (APIs) and pharmaceutical excipients, complemented by nutraceuticals and functional food. Through a global partner network, the company supplies customers from the pharmaceutical industry, the generics sector and the niche products field. In addition to product trading, the company offers in-licensing (brokering and sale of marketing authorisation dossiers in CTD format), contract development for active ingredients prior to patent expiry, and agency services for cooperation agreements. Its own logistics offering includes temperature-monitored storage (2–8 °C and 15–25 °C), consignment solutions, just-in-time distribution with a GDP-certified trailer, and import coordination from India and China via Rotterdam and Hamburg. Quality processes such as risk management, CAPA, change control and complaints management are an integral part of the services.
- Site
- Dorsten
- Processes
- Trading in well-documented active ingredients (APIs) and pharmaceutical excipients, Nutraceuticals & Functional Food, In-licensing / brokering and sale of marketing authorisation dossiers (CTD) and marketing, GDP-certified storage with temperature monitoring (2–8°C, 15–25°C), Temperature and humidity monitoring, consignment warehouse solutions, Transport management / just-in-time distribution with GDP-certified trailer, Import coordination from China (routes via Rotterdam and Hamburg), freight forwarding by road, air, Quality processes: risk management, CAPA, change control, complaints management
- Materials
- Active Pharmaceutical Ingredients, Pharmaceutical Excipients, Marketing Authorisation Dossiers (CTD Format)
- Certificates
- DIN EN ISO 9001:2015, GDP (Good Distribution Practice), ISO 9001
- Industries
- Pharmaceutical industry, Generics industry, Niche products / pharmaceutical research
- 01
Global sourcing of APIs and excipients
- 02
Quality inspection and regulatory documentation (CEP, ASMF, CTD)
- 03
GDP-certified storage with temperature monitoring
- 04
Transport management and just-in-time distribution
- 05
In-licensing and contract development as complementary services
Services and Products
Active Pharmaceutical Ingredients
Well-documented active ingredients with CEPs, ASMFs and other registration documents for the pharmaceutical and generics industry.
Pharmaceutical Excipients
Excipients for pharmaceutical manufacturing, complemented by nutraceuticals and functional food.
Marketing Authorisation Dossiers (CTD Format)
Brokering and sale of registration dossiers including BE studies for European authorisation procedures (MRP, DCP, National).
Locations
Dorsten
DERegistered Office
Reken
DECorporate Office, GDP-/ISO-certified warehouse (Warehousing & Distribution)
- Temperature-monitored storage areas at 2–8 °C and 15–25 °C
- Temperature and humidity monitoring
- GDP-certified trailer
Products
Inside the production
Industries
Additional services
Quality and Certifications
The management system is certified to DIN EN ISO 9001:2015 (TÜV NORD CERT, certificate no. 44 100 081045); the warehouse in Reken operates in accordance with GDP requirements. Quality processes include risk management, CAPA, change control and complaints management.
| Evidence | Dorsten | Reken |
|---|---|---|
| ISO 9001 | ||
| GDP (Good Distribution Practice) |
Company History
- 2008
Initial certification of the management system to ISO 9001 (TÜV NORD).
- 2023
Recertification to ISO 9001:2015 by TÜV NORD CERT GmbH, valid from 2023-12-23 to 2026-12-22.