Drug Product
Company Overview
About
Melody Healthcare is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Neurology
Quick Facts
HQ:India
Founded:2016
Employees:2,981
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
North America
Manufacturing Facilities
1 site worldwide
Melody Healthcare Pvt. Ltd.
Plot No. J-73, M.I.D.C. Tarapur Boisar, Palghar, Maharashtra, 401506
Site Capabilities
2 capabilitiesANALYSIS
API MANUFACTURE
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval IDGAVJ
FDA · #APR-95EMUVKJ · 2020-06-01
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-SVQDCZWW
Issued: 2020-08-13
Expires: 2025-05-17
WHO GMP
World Health Organization
Cert #: CERT-IAU2RUQM
Issued: 2020-02-07
Expires: 2025-11-13
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-38MS2R1U
Issued: 2020-09-11
Expires: 2025-02-07
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Key facts about Melody Healthcare
- Melody Healthcare is headquartered in India.
- Melody Healthcare was founded in 2016.
- Melody Healthcare has 2,981 employees.
- Melody Healthcare has one manufacturing site listed on CDMO Hub, in Palghar, India.
- Melody Healthcare's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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