Woodbridge, CT/Maharashtra, India — ChemWerth Inc. is pleased to announce Enaltec Laboratories has passed their first FDA overseas inspection with zero 483 being issued in August 2013. This is truly a significant accomplishment for the Enaltec/ChemWerth collaboration and a positive indicator of the commitment to FDA compliance and to providing quality APIs around the world. In addition to their compliance accreditations, Enaltec was presented last year with the Emerging India Award for the fastest growing SME – Small & Medium Enterprises in India.
Enaltec Labs, established in 2006, has become one of the few independent Indian API suppliers with world class infrastructure, providing the critical India advantage to generic formulators around the globe. Since inception, Enaltec’s objective has been to develop and produce complex, small volume, technology driven products. Anand Shah, president of Enaltec, stated “Enaltec’s goal is to become a first-class API supplier following the ChemWerth business model of one quality, one price for all markets”. Mr. Shah is pleased with the results from the collaboration with ChemWerth and will market Bromfenac Sodium, Tetrabenazine, Dronedarone, and recently developed sterile Nepafenac Sodium through ChemWerth for the USA and other regulated markets. Products under development are Clofarabine and Fampridine.
ChemWerth continues to be an industry leader in developing and training manufacturers of active pharmaceutical ingredients to become successfully cGMP compliant and FDA approved. According to Mr. Peter Werth, President and CEO of ChemWerth, “Enaltec’s approval is truly a good example of teamwork and cooperation. It is very difficult to earn a zero point form 483 with the increasing scrutiny imposed by the FDA. Everyone involved should be very proud of the job well done. ChemWerth is looking forward to the on-going collaboration with such an enthusiastic partner.”