Drug Product
Company Overview
About
AMN Life Science Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:India
Founded:2003
Employees:1,354
Capabilities & Services
Core Capabilities
- Sterile Injectable
- Sterile Fill/Finish
- Fill/Finish (Vials)
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Cartridge / Pen
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Asia-Pacific
International Regulatory
EU GMP Certificates
4
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval KGH5LZ
PMDA · #APR-R1O37M0M · 2019-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-M7EEXDOU
Issued: 2020-11-01
Expires: 2025-10-01
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-SYYIM8SV
Issued: 2020-03-22
Expires: 2025-11-03
Health Canada GMP
Health Canada
Cert #: CERT-WFM6CD1N
Issued: 2020-06-01
Expires: 2025-07-09
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Key facts about AMN Life Science Pvt Ltd
- AMN Life Science Pvt Ltd is headquartered in India.
- AMN Life Science Pvt Ltd was founded in 2003.
- AMN Life Science Pvt Ltd has 1,354 employees.
- AMN Life Science Pvt Ltd's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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