Manufacturing & Quality
Our manufacturing network comprises multiple state-of-the-art facilities ranging from small to large capacity and from single product to multiple product manufacturing facilities primarily located in and around Hyderabad and Vizag cities from the states of Andhra Pradesh & Telangana in south of India.
With deep desire to grow by using cutting-edge technologies, highly qualified professionals, high safety standards, and most up-to-date equipment to perform a wide variety of chemical reactions and to produce most cost competitive intermediates and APIs with high quality standards. These companies are GMP (Good Manufacturing Practice) compliant and the U.S. Food and Drug Administration (FDA) and are periodically inspected by leading pharmaceutical companies and regulatory bodies.
Pharmaceutical pipelines today require more flexibility in manufacturing than ever before. There is an increasing demand in accelerated development programs (i.e., orphan drugs, fast track, breakthrough therapy, accelerated approvals, and priority review) and oncology drugs that require smaller batch sizes, expedited development and manufacturing timelines, and the ability to efficiently adjust production volumes to meet market demands. Therefore, flexibility and adaptability are key to getting your API to market quickly.
We at NIRVI along with our manufacturing partners provide flexible manufacturing solutions for pharmaceutical, to our customers around the world. With our manufacturing expertise, breadth of scalable development and delivery technologies, and our exceptional quality standards, we can support your requirements with reliable supply on time and with high quality.
Our manufacturing partners have domestic and internationally approved facilities, we can provide flexible manufacturing at the right scale for your developmental and commercial manufacturing needs. Our proven expertise in technical transfers, product launches, dedicated suites, special handling, and manufacturing technologies, NIRVI Labs can strategically support a wide range of small- to- large-scale manufacturing services.
Quality
We have selected well-established and reputable high-quality manufacturers for our Intermediates, APIs and FDF with good regulatory standing, large manufacturing capacities and multiple manufacturing sites within their business footprint.
These manufacturers comply with applicable regulatory requirements, including the FDA’s Current Good Manufacturing Practice (GMP), the EC’s Guidelines on Good Distribution Practice (GDP), as well as other stringent regulatory requirements enforced by the local Drug Authorities or foreign regulatory agencies, as
applicable, and are subject to routine inspections by such regulatory agencies. We monitor and evaluate the performance of our manufacturing partners on an ongoing basis for compliance with updated regulatory requirements and affirm their continuing capabilities to meet both our commercial and quality needs.