Solupharm GmbH
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Solupharm GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Neurology
Quick Facts
HQ:Germany
Founded:1996
Employees:709
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
North America
Manufacturing Facilities
1 site worldwide
Solupharm Pharmazeutische Erzeugnisse GmbH
Industriestraße 3, Melsungen, Hesse D-, 34212
Site Capabilities
5 capabilitiesANALYSIS
LABEL
MANUFACTURE
PACK
STERILIZE
Regulatory Approvals
Drug Approval 6FZ5TI
PMDA · #APR-GRSBYLTK · 2019-06-01
Drug Approval 2UGJ8A
EMA · #APR-T27HS4YH · 2020-06-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-MWI1WJAA
Issued: 2020-04-10
Expires: 2025-01-08
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-KCSI81PN
Issued: 2020-11-19
Expires: 2025-08-01
WHO GMP
World Health Organization
Cert #: CERT-WRXVIMOP
Issued: 2020-06-22
Expires: 2025-07-19
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Key facts about Solupharm GmbH
- Solupharm GmbH is headquartered in Germany.
- Solupharm GmbH was founded in 1996.
- Solupharm GmbH has 709 employees.
- Solupharm GmbH has one manufacturing site listed on CDMO Hub, in Melsungen, Germany.
- Solupharm GmbH's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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