Our company was established in the U.S. in 1986. Since then, we have supplied cGMP active pharmaceutical ingredients (APIs), vitamins and nutritional supplements to the human generic and veterinary industries. Our main products are fermentation antibiotics, sulfa drugs, antihelmentics and other anti-infectives for oral and injectible formulations. Additionally, we are one of the largest suppliers of food color raw materials, flavors, fragrances and natural colors in the U.S. Our office in Hong Kong is staffed with a regulatory team that visits our manufacturers in China, conducting regular cGMP audits and assisting in the preparation and translation of master files.
· Over 50 DMFs filed with CDER and CVM
· 20 new DMF products currently under development in 2010
· Broad spectrum of APIs in over 100 approved ANADAs, NADAs or ANDAs
· All regulatory compliance work including periodic cGMP audits and attendance at all cGMP FDA inspections are performed “in-house.”
You can reach our main office in the U.S. in Montvale, New Jersey at 201.573.9220 or you can contact us through the Internet by sending an e-mail to mail@newchemic.com.
