Advanced Modalities
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Landmark Bio is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:United States
Founded:2011
Employees:631
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
North America
Regulatory Approvals
Drug Approval LP75YY
Health Canada · #APR-WTU0N7ZL · 2018-09-01
Drug Approval T423T9
FDA · #APR-MIQKBP1W · 2021-10-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-HL1L8PSC
Issued: 2020-08-05
Expires: 2025-06-18
Health Canada GMP
Health Canada
Cert #: CERT-25E8TQKI
Issued: 2020-05-15
Expires: 2025-11-28
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Key facts about Landmark Bio
- Landmark Bio is headquartered in the United States.
- Landmark Bio was founded in 2011.
- Landmark Bio has 631 employees.
- Landmark Bio's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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