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Production is carried out in accordance with cGMP and the facilities are regularly inspected by the FDA, DHSS, HPB and/or several of our customer’s internal auditing teams. Quality assurance is a company-wide activity involving all departments and individuals. The quality of all products is ensured by a well-qualified and trained staff working in sophisticated and up-to-date analytical laboratories equipped with the latest instrumentation.

Working closely with our manufacturing facilities, Prime Pharma assists in compiling complete and accurate Drug Master Files (DMFs) and Abbreviated Antibiotic Drug Applications (AADAS) in support of NDAs and ANDAS. Experienced regulatory personnel keep our factories advised of all current FDA regulations, assisting them in filing, updating and amending their DMFs and perform periodic factory audits to assure cGMP compliance.

Our greatest resource is our people — high caliber professionals at all levels who are fully committed to maintaining our reputation for responsiveness, dependability and, most important in contract and toll manufacture, complete customer confidentiality.

With offices, production sites and affiliated companies throughout the world, Prime Pharma is positioned to provide products and services to customers everywhere. By operating to the highest quality, environmental and safety standards, we deliver the same security of supply which you may have thought was only available in-house.

Through strict quality control procedures, Prime Pharma ensures the manufacture of high quality products while maintaining high standards in plant cleanliness, worker safety, and environmental quality. Quality is enforced at every stage—starting with the establishment and enforcement of rigid standards for incoming materials, and proceeding with the testing and monitoring of in process work, and concluding with the release of finished products which meet all established quality parameters. Through decades of effective quality controls, our facilities have eared a reputation for excellence.

A dedicated team of highly qualified personnel and state of the art equipment combine to meet even the most complex requirements of individual customers whether they are small companies or multinationals. Our quality commitment assures you of consistent product performance, timely service, dependability of shipments and the security and confidence you expect when you work with a leader.

As a company committed to human health and welfare, the respect of the environment is a mandatory part of its operating policy and future growth. Our facilities are equipped with the latest in waste disposal systems.

Our production facilities ensure the safety of their wastewater and air effluent through aggressive pretreatment and monitoring programs. Any waste is properly treated and/or disposed of in accordance with strict regulatory guidelines so as not to affect human health or the environment.

Investment in on-site waste minimization (solvent recovery) and treatment (scrubbing, incineration) has put Prime Pharma at the forefront of the specialty chemicals industry in our demonstrable commitment to protection of the environment.