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airis PHARMA’s vision is to develop generic drug formulation products primarily for the USA market and other markets such as Europe, NZ, Australia, and the UK. The generic products range in complexity from oral solids to injectables. The company is located in Hyderabad, India. We have started our operations in 2014 and filed a few ANDAs and a few of them had received approval and commercialized through marketing partners and a few under review at FDA. Our R&D and analytical testing site were audited by FDA with “Zero 483”. We use an electronic lab notebook for formulation as well as analytical development. The teams and the facility are geared toward the development of diverse dosage forms with a mission of adding value with high-quality standards. The company is armed with a strong technical team from formulation research and development, analytical research and development, Global Regulatory Affairs, and Quality assurance. The facility is a 100% Exported Oriented Unit. The company’s mantra is ‘simply quality Cenetered’ and the teams believe it will be the key to success. Using a well-conceived quality management system and implementing Quality by Design (QbD), the teams ensure that quality will be built into drug products during development and will continue during commercial manufacturing. This mindset will ensure that drug products meet therapeutic and pharmaceutical equivalence leading to patient compliance.
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