Drug Product
Analytical & Bioanalytical Services
Company Overview
About
Lief Labs is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:United States
Founded:2011
Employees:972
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
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval 2VIW6G
Health Canada · #APR-TPC6PHSB · 2019-05-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-4KIPD15E
Issued: 2020-04-16
Expires: 2025-06-10
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-C7WHYSSK
Issued: 2020-02-11
Expires: 2025-04-07
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-0XUY2UQW
Issued: 2020-02-08
Expires: 2025-02-23
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Key facts about Lief Labs
- Lief Labs is headquartered in the United States.
- Lief Labs was founded in 2011.
- Lief Labs has 972 employees.
- Lief Labs's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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