Galentic Pharma (India) Pvt Ltd
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Drug Product
Company Overview
About
Galentic Pharma (India) Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:India
Founded:2018
Employees:2,246
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Asia-Pacific
Manufacturing Facilities
2 sites worldwide
Galentic Pharma (India) Private Limited
Plot No.5B & 5C Sector III, Kandla SEZ, Gandhidham, Gujarat, 370230
Site Capabilities
4 capabilitiesANALYSIS
MANUFACTURE
PACK
STERILIZE
Galentic Pharma (India) Private Limited
Unit 1, R-673 T T C Midc, Thane Belapur Road, Navi Mumbai
Regulatory Approvals
Drug Approval OZTLGS
PMDA · #APR-C4EJ6QM6 · 2020-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-HIYDG5MQ
Issued: 2020-05-14
Expires: 2025-09-02
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-AEHJYGOL
Issued: 2020-06-25
Expires: 2025-09-06
WHO GMP
World Health Organization
Cert #: CERT-SXQ1VAYH
Issued: 2020-10-05
Expires: 2025-10-20
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-CB6OT5XG
Issued: 2020-05-09
Expires: 2025-04-08
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Key facts about Galentic Pharma (India) Pvt Ltd
- Galentic Pharma (India) Pvt Ltd is headquartered in India.
- Galentic Pharma (India) Pvt Ltd was founded in 2018.
- Galentic Pharma (India) Pvt Ltd has 2,246 employees.
- Galentic Pharma (India) Pvt Ltd has 2 manufacturing sites listed on CDMO Hub, in Gandhidham, India and Navi Mumbai, India.
- Galentic Pharma (India) Pvt Ltd's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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