Home
Products
Contact
   
 

NEW PRODUCTS AND NEW IDEAS FOR 2015

Our company was established in the U.S. in 1986. Since then, we have supplied cGMP active pharmaceutical ingredients (APIs), OTC pharmaceuticals, 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 dyestuffs and dyestuff intermediates, flavors, fragrances and natural colors in the U.S. Our office in Hong Kong is staffed with a regulatory team that regularly visits the Chinese manufacturers we represent, conducting GMP audits and assisting in the preparation and translation of master files.  

NEW PRODUCTS FOR 2015

Albenatide
Apixaban
Bemiparin Sodium
Dabigatran Etexilate
Lapatinib
Milbemycin
Nilotinib
Parnaparin Sodium
Sodium Hyaluronate
Sulodexide

COMPANY HIGHLIGHTS

· Over 80 DMFs filed with CDER and CVM

· 20 new DMF products currently under development 

· 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.


 Find us on Facebook: New Chemic Group