Gennex Laboratories Limited
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Drug Product
Company Overview
About
Gennex Laboratories Limited is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:India
Founded:2007
Employees:642
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 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Global
Regulatory Approvals
Drug Approval XJRKER
PMDA · #APR-OY34IX41 · 2021-11-01
Drug Approval 3SII40
EMA · #APR-RAYW6JDZ · 2022-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-ER3DXZ1J
Issued: 2020-06-21
Expires: 2025-12-16
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-KHMBRV43
Issued: 2020-09-07
Expires: 2025-09-11
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-KA0WFJK4
Issued: 2020-09-17
Expires: 2025-03-11
Health Canada GMP
Health Canada
Cert #: CERT-B8R4WQJQ
Issued: 2020-05-05
Expires: 2025-03-10
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Key facts about Gennex Laboratories Limited
- Gennex Laboratories Limited is headquartered in India.
- Gennex Laboratories Limited was founded in 2007.
- Gennex Laboratories Limited has 642 employees.
- Gennex Laboratories Limited's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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