Macrocyclics, Inc.
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Excipients & Specialty Ingredients
Company Overview
About
Macrocyclics, Inc. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:United States
Founded:2000
Employees:2,806
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval U5DSIP
FDA · #APR-M8PAP1YP · 2019-04-01
Drug Approval 1YA5QD
EMA · #APR-4EPJUPYK · 2019-06-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-5N8EXWA7
Issued: 2020-10-13
Expires: 2025-10-06
Health Canada GMP
Health Canada
Cert #: CERT-RYX7EMQ1
Issued: 2020-08-15
Expires: 2025-03-17
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Key facts about Macrocyclics, Inc.
- Macrocyclics, Inc. is headquartered in the United States.
- Macrocyclics, Inc. was founded in 2000.
- Macrocyclics, Inc. has 2,806 employees.
- Macrocyclics, Inc.'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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