Aurohealth LLC is a pharmaceutical company that develops, manufactures, markets and distributes store brand Over the Counter (OTC) products. Our mission is to develop as many OTC products for the US retail market providing a consistent and reliable supply, at a fair price, and of the highest quality. We are very customer focused organization that continuously seeks ways to be a reliable source for our customer’s needs.
Our targets include Rx to OTC switch molecules, ANDA & Monograph OTC products in various dosage forms / formats solids (tablets, capsules, soft gels), liquids, semi solids & nasal sprays. Our FDA approved manufacturing sites are located in USA & India.
GMP/GLP/GDP regulations and guidelines. Manages various QMS processes including Document & Records Control, Internal Audits, Supplier Management, Quality Agreements, Training, and CAPA. Compile data for documentation of test procedures and prepare reports. Create, advise on and support the establishment and continual improvement of Standard Operating Procedures and Work Instructions. Develop validation master plans based on FDA/EMA guidance for all processes and methods related to our lead product and follow on products (GMP).