Component APIs — where each ingredient comes from
6 verified API manufacturers
6 verified API manufacturers
Finished-combination manufacturers
Companies with a filed amphetamine + dextroamphetamine finished product. Approval reach is
reconciled against the FDA Orange Book, EMA and WHO-PQ.
US ANDA/NDA (Orange Book) 211547
US ANDA/NDA (Orange Book) 211876
Granules India Limited
US
US ANDA/NDA (Orange Book) 217027
Teva Farmaceutica Ltda.
BR
US ANDA/NDA (Orange Book) 077488
US ANDA/NDA (Orange Book) 040444
US ANDA/NDA (Orange Book) 214403
Oryza Pharmaceuticals Inc.
US
US ANDA/NDA (Orange Book) 210293
Ani Pharmaceuticals, Inc.
US
US ANDA/NDA (Orange Book) 205401
Amneal Pharmaceuticals Of New York Llc
US
No US/EU/WHO combination approval matched — verified maker, national registration only.
Sun Pharmaceutical Industries Ltd.
IN
US ANDA/NDA (Orange Book) 211715
Glenmark Pharmaceuticals S.R.O.
BR
No US/EU/WHO combination approval matched — verified maker, national registration only.