Drug Product
Advanced Modalities
Analytical & Bioanalytical Services
Clinical Trial Supply & Logistics
Regulatory, Tech Transfer & Support Services
Company Overview
About
SpectronRx is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:Belgium
Founded:1997
Employees:3,013
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
Nukemed, Inc dba SpectronRx
17490 Dugdale Drive, SOUTH BEND, Indiana, 46635
Site Capabilities
1 capabilityMANUFACTURE
Regulatory Approvals
Drug Approval KWLZB0
PMDA · #APR-TZ77254K · 2018-04-01
Drug Approval 619GGF
FDA · #APR-98NBQA7O · 2020-09-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-Q1PI0GJK
Issued: 2020-07-28
Expires: 2025-10-21
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-FHGRYZ7K
Issued: 2020-05-01
Expires: 2025-09-16
WHO GMP
World Health Organization
Cert #: CERT-OPLNWLUK
Issued: 2020-11-11
Expires: 2025-03-03
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-9SZG3HB6
Issued: 2020-11-17
Expires: 2025-07-01
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Key facts about SpectronRx
- SpectronRx is headquartered in Belgium.
- SpectronRx was founded in 1997.
- SpectronRx has 3,013 employees.
- SpectronRx has one manufacturing site listed on CDMO Hub, in SOUTH BEND, United States.
- SpectronRx's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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