Drug Product
Analytical & Bioanalytical Services
Company Overview
About
NGL Fine Chem Limited is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Neurology
Quick Facts
HQ:India
Founded:2017
Employees:2,209
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
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Asia-Pacific
Manufacturing Facilities
1 site worldwide
NGL FINE-CHEM LIMITED
Unit No. 4, S-18/3, MIDC, Tarapur Industrial Area, Boisar, Palghar, Maharashtra, 401506
Site Capabilities
1 capabilityAPI MANUFACTURE
Regulatory Approvals
Drug Approval EEJ2MT
FDA · #APR-KJE9SKFX · 2020-08-01
Certifications
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-QAVYT20N
Issued: 2020-10-20
Expires: 2025-02-02
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-GX87UDWQ
Issued: 2020-07-06
Expires: 2025-01-11
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-YQUSSR9M
Issued: 2020-10-15
Expires: 2025-09-23
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-5C95TFB7
Issued: 2020-09-17
Expires: 2025-12-09
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Key facts about NGL Fine Chem Limited
- NGL Fine Chem Limited is headquartered in India.
- NGL Fine Chem Limited was founded in 2017.
- NGL Fine Chem Limited has 2,209 employees.
- NGL Fine Chem Limited has one manufacturing site listed on CDMO Hub, in Palghar, India.
- NGL Fine Chem Limited's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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