Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Aragen Life Sciences Ltd. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Neurology
Quick Facts
HQ:India
Founded:2007
Employees:2,011
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
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
North America
Manufacturing Facilities
3 sites worldwide
Aragen Life Sciences Limited
Manufacturing Unit-1, Plot No.28A, IDA, Nacharam Village Uppal Mandal, Medchal-Malkajgiri District,, Hyderabad, Telangana, 500076
Site Capabilities
1 capabilityAPI MANUFACTURE
Aragen Life Sciences Limited
Analytical Services, Survey Nos. 125 (part) & 126 IDA, Mallapur, Hyderabad, Telangana, 500076
Site Capabilities
1 capabilityANALYSIS
Aragen Life Sciences Limited
Manufacturing Unit-II, Plot No. 94, SEZ, Jawaharlal Nehru Pharma City, Lemarthi (V), Parawada (M), Anakapalli District, Andhra Pradesh, 531019
Site Capabilities
1 capabilityAPI MANUFACTURE
Regulatory Approvals
Drug Approval 1C5MRI
Health Canada · #APR-XTTF5CK9 · 2020-11-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-YJPOLYVW
Issued: 2020-01-16
Expires: 2025-10-07
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-BKSMOH9C
Issued: 2020-09-08
Expires: 2025-01-11
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-0QBMUJXX
Issued: 2020-04-13
Expires: 2025-08-14
Health Canada GMP
Health Canada
Cert #: CERT-GZNT919U
Issued: 2020-08-25
Expires: 2025-07-03
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Key facts about Aragen Life Sciences Ltd.
- Aragen Life Sciences Ltd. is headquartered in India.
- Aragen Life Sciences Ltd. was founded in 2007.
- Aragen Life Sciences Ltd. has 2,011 employees.
- Aragen Life Sciences Ltd. has 3 manufacturing sites listed on CDMO Hub, in Hyderabad, India and Anakapalli District, India.
- Aragen Life Sciences Ltd.'s capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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