Drug Product
Analytical & Bioanalytical Services
Company Overview
About
Gufic Biosciences 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:2006
Employees:2,093
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
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Global
Manufacturing Facilities
2 sites worldwide
GUFIC BIOSCIENCES LIMITED
Smart Industrial Park, Plot no.48, Near NATRIP, Pithampur., Dhar, Madhya Pradesh, 454775
Site Capabilities
5 capabilitiesANALYSIS
LABEL
MANUFACTURE
PACK
STERILIZE
Gufic Biosciences Limited
National Highway No. 8, Near Grid, Navsari
International Regulatory
EU GMP Certificates
5
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval YRFX7K
PMDA · #APR-2K8OPBAS · 2022-05-01
Drug Approval V2KM2X
Health Canada · #APR-2XPRDE1V · 2020-09-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-ANHMDMQM
Issued: 2020-11-26
Expires: 2025-02-04
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-IDZ4QOJN
Issued: 2020-03-07
Expires: 2025-11-14
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-DHSTQ149
Issued: 2020-08-18
Expires: 2025-10-12
WHO GMP
World Health Organization
Cert #: CERT-AXHS7FMM
Issued: 2020-11-01
Expires: 2025-07-27
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Key facts about Gufic Biosciences Ltd
- Gufic Biosciences Ltd is headquartered in India.
- Gufic Biosciences Ltd was founded in 2006.
- Gufic Biosciences Ltd has 2,093 employees.
- Gufic Biosciences Ltd has 2 manufacturing sites listed on CDMO Hub, in Dhar, India and Navsari, India.
- Gufic Biosciences Ltd's capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
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