KeyCare Drugs Pvt. Ltd., established in 2022, is a fast-growing and innovation-driven organization engaged in the manufacture and marketing of medical diagnostic and laboratory consumables. The company specializes in Blood Collection Tubes (BCTs) and their accessories, along with a comprehensive range of laboratory disposables serving hospitals, diagnostic laboratories, and healthcare institutions.
KeyCare Drugs Pvt. Ltd. operates under a robust and integrated Quality Management System (QMS) and is committed to maintaining the highest standards of product quality, safety, and regulatory compliance. The company is certified to ISO 13485:2016 for medical devices and ISO 9001:2015 for quality management systems, ensuring systematic control over design, manufacturing, validation, traceability, risk management, and continual improvement.
All manufacturing processes comply with applicable Medical Device Rules (MDR), India, and adhere to established Good Manufacturing Practices (GMP). Products requiring sterility are processed through validated Gamma Irradiation sterilization, ensuring effective microbial reduction while maintaining product integrity and performance.
Strict adherence to documented procedures for process validation, environmental monitoring, equipment calibration, bioburden control, sterility assurance, and quality assurance ensures consistent product performance and patient safety. Comprehensive in-process controls and final quality inspections are conducted prior to product release to verify conformity to defined specifications.
With a strong emphasis on innovation, operational excellence, and customer satisfaction, KeyCare Drugs Pvt. Ltd. continuously invests in advanced manufacturing technologies, skilled manpower, and stringent testing protocols.
Driven by a vision to become a trusted and preferred partner in diagnostic healthcare, the company is dedicated to delivering compliant, reliable, and value-driven solutions, while upholding ethical business practices and contributing positively to improved healthcare outcomes.
