Drug Product
Company Overview
About
R L Fine Chem Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:India
Founded:1996
Employees:2,880
Capabilities & Services
Core Capabilities
- Peptide Synthesis
- Small Molecule API
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Inhalation
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Global
Manufacturing Facilities
1 site worldwide
R L Fine Chem
No. 15, KHB Industrial Area, Bangalore, Karnataka, 560064
Site Capabilities
1 capabilityAPI MANUFACTURE
Regulatory Approvals
Drug Approval 7XWOK8
FDA · #APR-BCDW7JHE · 2022-07-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-IPO4U77E
Issued: 2020-10-07
Expires: 2025-03-08
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-IAT56L2F
Issued: 2020-08-07
Expires: 2025-07-11
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-NAXNALW9
Issued: 2020-04-11
Expires: 2025-01-12
Health Canada GMP
Health Canada
Cert #: CERT-X00LS2WN
Issued: 2020-12-22
Expires: 2025-06-19
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Key facts about R L Fine Chem Pvt Ltd
- R L Fine Chem Pvt Ltd is headquartered in India.
- R L Fine Chem Pvt Ltd was founded in 1996.
- R L Fine Chem Pvt Ltd has 2,880 employees.
- R L Fine Chem Pvt Ltd has one manufacturing site listed on CDMO Hub, in Bangalore, India.
- R L Fine Chem Pvt Ltd's capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
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