The certification, granted by the Food Safety & Drugs Administration Authority of Uttarakhand, follows an inspection conducted in December 2024.
The company confirmed in a regulatory filing that the certification states the firm is following Good Manufacturing Practices as per World Health Organization (WHO) TRS Guidelines.
Hitesh Windlass, managing director, Windlas Biotech said, “The certification marks a new chapter in Windlas Biotech’s growth trajectory, bolstering its reputation as a trusted name in the pharmaceutical manufacturing sector. This underscores our unwavering commitment to quality, innovation, and compliance with the highest regulatory standards. The GMP certification for the injectable facility not only validates our adherence to stringent manufacturing protocols but also strengthens our ability to meet the growing demand for high-quality injectable pharmaceutical products, both domestically and globally.
The state-of-the-art facility has been designed with cutting-edge technology and advanced infrastructure to ensure the efficient and safe production of sterile injectable formulations. Equipped with automated systems, robust quality control mechanisms, and eco-friendly processes, the facility exemplifies our strategic focus on operational excellence and sustainability.
With this new GMP-certified injectable facility, all five of Windlas Biotech Manufacturing plants are complying to this standard and we are well poised to expand our product portfolio offerings in the CDMO space. It will enable us to cater to a wider spectrum of therapeutic areas, thereby contributing to improved patient outcomes and better access to essential medicines.”
Windlas Biotech provides a comprehensive range of CDMO services, ranging from product discovery, product development, licensing, and commercial manufacturing of generic products (including complex generics) with a focus on improved safety, efficacy and cost.
Windlas Biotech's consolidated net profit rose 11.6% to Rs 15.66 crore on a 22.5% jump in net sales to Rs 187 crore in Q2 FY25 over Q2 FY24.