Drug Product
Manufacturing & Lab Equipment
Company Overview
About
SMC Ltd. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Costa Rica
Founded:1996
Employees:2,833
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
SMC Ltd.
18 Independence Drive, Devens, Massachusetts, 01434
Site Capabilities
2 capabilitiesLABEL
PACK
Regulatory Approvals
Drug Approval FREONE
Health Canada · #APR-00BJ0LWU · 2020-04-01
Drug Approval 69PG1D
PMDA · #APR-08ER832M · 2019-04-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-04NZ3EEW
Issued: 2020-03-16
Expires: 2025-05-07
Health Canada GMP
Health Canada
Cert #: CERT-IM92NZMA
Issued: 2020-07-21
Expires: 2025-11-16
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Key facts about SMC Ltd.
- SMC Ltd. is headquartered in Costa Rica.
- SMC Ltd. was founded in 1996.
- SMC Ltd. has 2,833 employees.
- SMC Ltd. has one manufacturing site listed on CDMO Hub, in Devens, United States.
- SMC Ltd.'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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