Manufacturing unit
Advanced IVD Manufacturing Facility Built for Quality, Precision & Innovation
ASHSKY CHEM INDIA PRIVATE LIMITED operates a modern, state-of-the-art manufacturing facility dedicated to the production of In Vitro Diagnostic (IVD) products, including Hematology Reagents, Biochemistry Reagents, Hematology Analyzers, Biochemistry Analyzers, and POCT Diagnostic Solutions.
Our manufacturing unit is designed to meet stringent quality, safety, and regulatory requirements, ensuring consistent product performance and customer satisfaction.
The facility operates under IVD CDSCO Licence No. MFG/IVD/2026/000070 and an ISO 13485:2016 Certified Quality Management System, following standardized manufacturing processes and strict quality control at every stage.
Manufacturing Capabilities
Our advanced production facility is equipped for:
Hematology Reagent Manufacturing
Biochemistry Reagent Manufacturing
Clinical Chemistry Reagent Production
Hematology Analyzer Assembly & Testing
Biochemistry Analyzer Assembly
POCT Product Manufacturing
OEM & Private Label Manufacturing
Customized Product Development
Our Manufacturing Strengths
✔ Modern Automated Production Lines
✔ Advanced Laboratory & Quality Control Facility
✔ High-Purity Water Treatment System
✔ Controlled Manufacturing Environment
✔ Precision Mixing & Batch Processing
✔ Automated Filling, Capping & Labeling
✔ Strict Batch Traceability
✔ In-Process & Final Quality Inspection
✔ Secure Warehousing & Distribution
Quality Assurance
Every product manufactured at ASHSKY CHEM INDIA PRIVATE LIMITED undergoes comprehensive quality testing before release. Our Quality Assurance team follows validated procedures to ensure:
High Accuracy & Precision
Batch-to-Batch Consistency
Product Stability
Long Shelf Life
Reliable Diagnostic Performance
Regulatory Compliance
Research & Development
Innovation is at the heart of our manufacturing operations. Our dedicated Research & Development team continuously works on developing advanced diagnostic reagents and technologies to meet the evolving needs of laboratories and healthcare professionals.
OEM & Private Label Manufacturing
We provide complete OEM and Private Label Manufacturing services for distributors, medical device companies, and healthcare brands. From formulation and manufacturing to packaging and labeling, we deliver customized solutions tailored to customer requirements while maintaining the highest quality standards.
Why Choose Our Manufacturing Unit?
IVD CDSCO Licensed Manufacturing Facility
ISO 13485:2016 Certified Quality Management System
Experienced Technical & Production Team
Advanced Manufacturing Infrastructure
Strict Regulatory Compliance
High Production Capacity
Customized OEM Solutions
Reliable Supply Chain & On-Time Delivery
PAN India Distribution & Global Export Support
Manufacturing Excellence You Can Trust
At ASHSKY CHEM INDIA PRIVATE LIMITED, our manufacturing unit reflects our commitment to quality, innovation, precision, and regulatory compliance. Every product is developed and manufactured with the goal of delivering dependable diagnostic solutions that healthcare professionals can trust.
ASHSKY CHEM INDIA PRIVATE LIMITED
Manufacturing Precision. Delivering Quality. Building Trust.
A Manufacturing Unit Gallery
ISO 13485:2016 Certified Medical Device Manufacturer
Quality You Can Trust. Certified Excellence.
ASHSKY CHEM INDIA PRIVATE LIMITED is proud to be certified under ISO 13485:2016, the internationally recognized Quality Management System (QMS) standard for medical device manufacturers.
This certification demonstrates our commitment to maintaining the highest standards of quality, safety, regulatory compliance, and continuous improvement in the design, development, manufacturing, sales, and distribution of In Vitro Diagnostic (IVD) products.
Our quality management system ensures that every product is manufactured with strict quality control, validated processes, and comprehensive documentation to consistently deliver reliable diagnostic performance.
The ISO 13485:2016 certification covers the:
Design & Development
Manufacturing
Sales & Distribution
Hematology Reagents
Biochemistry Reagents
Clinical Chemistry Kits
Hematology Analyzers
Biochemistry Analyzers
In Vitro Diagnostic (IVD) Products
Medical Device Quality Management Systems
Why Our ISO 13485 Certification Matters
✔ Internationally Recognized Quality Standard
✔ Consistent Product Quality & Batch Reliability
✔ Regulatory Compliance
✔ Advanced Manufacturing Processes
✔ Comprehensive Quality Control
✔ Customer-Focused Manufacturing
✔ Continuous Improvement & Risk Management
✔ Trusted by Diagnostic Laboratories, Hospitals & Healthcare Professionals
CDSCO Licensed Medical Device Manufacturer
Government of India Approved Manufacturing Licence
ASHSKY CHEM INDIA PRIVATE LIMITED is proud to hold a CDSCO (Central Drugs Standard Control Organization) Manufacturing Licence under the Medical Devices Rules, 2017, issued by the Government of India.
Our manufacturing licence authorizes us to manufacture, sell, and distribute Class A & Class B In Vitro Diagnostic (IVD) Medical Devices, ensuring that every product is produced in compliance with the highest regulatory, quality, and safety standards.
Manufacturing Licence Details
Licence Type: Form MD-5
Licence Number: MFG/IVD/2026/000070
Issued By: Central Drugs Standard Control Organization (CDSCO), Government of India
Medical Device Classification: Class A & Class B IVD Medical Devices
Manufacturing Facility: C-02, Sector-88, Noida, Uttar Pradesh, India
Licensed Product Categories
Our CDSCO manufacturing licence covers the design, development, manufacturing, sale, and distribution of a wide range of IVD Medical Devices, including:
Hematology Reagents
Biochemistry Reagents
Clinical Chemistry Reagents
Hematology Analyzer Reagents
Diluents
Lyse Reagents
Diff Lyse
Rinse & Cleaner Solutions
Diagnostic Consumables
OEM & Private Label IVD Products
Regulatory Compliance
At ASHSKY CHEM INDIA PRIVATE LIMITED, every product is manufactured in accordance with:
Medical Devices Rules, 2017
CDSCO Regulatory Guidelines
ISO 13485:2016 Quality Management System
Good Manufacturing Practices (GMP)
Strict Quality Control & Validation Procedures
Why Our CDSCO Licence Matters
✔ Government of India Approved Manufacturing Facility
✔ Legally Authorized to Manufacture IVD Medical Devices
✔ Compliance with National Regulatory Standards
✔ High Quality & Reliable Diagnostic Products
✔ Safe, Consistent & Validated Manufacturing Processes
✔ Trusted by Hospitals, Diagnostic Laboratories & Healthcare Professionals
✔ OEM & Private Label Manufacturing Available
Our Commitment
With our CDSCO Manufacturing Licence (MFG/IVD/2026/000070) and ISO 13485:2016 Certification, ASHSKY CHEM INDIA PRIVATE LIMITED is committed to delivering safe, reliable, and high-performance IVD products that meet both Indian and international quality standards.
We continuously invest in advanced manufacturing technology, quality assurance, and regulatory compliance to support accurate diagnostics and improve healthcare outcomes.
ASHSKY CHEM INDIA PRIVATE LIMITED
CDSCO Licensed IVD Manufacturer | ISO 13485:2016 Certified | OEM & Private Label Manufacturing | Trusted Diagnostic Solutions
