NOVITIUM PHARMA LLC
Overview
NOVITIUM PHARMA LLC is an active pharmaceutical ingredient (API) supplier with 12 active FDA Type II Drug Master Files, covering BETAINE ANHYDROUS; CARGLUMIC ACID; DAPSONE USP; DIAZOXIDE USP; DICHLORPHENAMIDE USP; FLUDROCORTISONE ACETATE USP.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances NOVITIUM PHARMA LLC is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
NOVITIUM PHARMA LLC holds 12 active (12 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- FLUDROCORTISONE ACETATE USPActive2020-06-09
- BETAINE ANHYDROUSActive2020-03-12
- METHYLTESTOSTERONE USPActive2019-12-17
- DICHLORPHENAMIDE USPActive2019-12-10
- LEVORPHANOL TARTRATE USPActive2018-12-31
- CARGLUMIC ACIDActive2018-12-07
- OXANDROLONE USPActive2017-10-28
- THIOTHIXENE USPActive2017-07-21
- PRAZOSIN HYDROCHLORIDE USPActive2017-06-16
- DIAZOXIDE USPActive2017-01-27
- NITISINONEActive2017-01-02
- DAPSONE USPActive2013-12-13
FDA compliance signals
6 FDA enforcement records linked to this company.
- recall — Class III2024-04-24
Failed Impurities/Degradation Specifications
- recall — Class III2024-03-27
Cross Contamination with Other Products:(mycophenolate mofetil).
- recall — Class II2019-11-20
CGMP Deviations: Presence of NDMA impurity detected in product.
- recall — Class II2019-11-20
CGMP Deviations: Presence of NDMA impurity detected in product.
- recall — Class II2019-11-20
CGMP Deviations: Presence of NDMA impurity detected in product.
- recall — Class II2019-11-20
CGMP Deviations: Presence of NDMA impurity detected in product.
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