Drug Product
Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
NJ Bio, Inc. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:India
Founded:2011
Employees:128
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
North America
Regulatory Approvals
Drug Approval GU3QT2
Health Canada · #APR-2BJJUIB2 · 2021-09-01
Drug Approval CK67CO
Health Canada · #APR-I66IVOQI · 2019-02-01
Certifications
Health Canada GMP
Health Canada
Cert #: CERT-C3YLAQD0
Issued: 2020-01-03
Expires: 2025-06-25
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-98OCDEGO
Issued: 2020-02-06
Expires: 2025-07-28
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-3SO7KYOJ
Issued: 2020-05-13
Expires: 2025-05-11
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-Q4WVXAPL
Issued: 2020-07-16
Expires: 2025-03-11
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Key facts about NJ Bio, Inc.
- NJ Bio, Inc. is headquartered in India.
- NJ Bio, Inc. was founded in 2011.
- NJ Bio, Inc. has 128 employees.
- NJ Bio, Inc.'s capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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