Mikart, LLC
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Drug Product
Analytical & Bioanalytical Services
Clinical Trial Supply & Logistics
Regulatory, Tech Transfer & Support Services
Company Overview
About
Mikart, LLC is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Neurology
Quick Facts
HQ:United States
Founded:2001
Employees:2,975
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
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
Mikart, LLC
2090 Marietta Boulevard NW, Atlanta, Georgia, 30318
Site Capabilities
1 capabilityMANUFACTURE
Regulatory Approvals
Drug Approval PU0N7A
EMA · #APR-7J9PPVV2 · 2018-03-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-75FFAR1Z
Issued: 2020-03-04
Expires: 2025-01-28
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-87XVV8S9
Issued: 2020-07-17
Expires: 2025-07-08
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-40YOX4UX
Issued: 2020-11-06
Expires: 2025-05-06
WHO GMP
World Health Organization
Cert #: CERT-H79XJ2PL
Issued: 2020-02-06
Expires: 2025-03-08
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Key facts about Mikart, LLC
- Mikart, LLC is headquartered in the United States.
- Mikart, LLC was founded in 2001.
- Mikart, LLC has 2,975 employees.
- Mikart, LLC has one manufacturing site listed on CDMO Hub, in Atlanta, United States.
- Mikart, LLC's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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