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We develop, manufacture, and commercialize specialty complex injectable products, generic and 505(b)(2) innovative complex injectable products.
Pipeline
PRODUCT CANDIDATE | REGULATORY PATHWAY | INDICATION | DEVELOPMENT | CLINICAL STUDY/BE | REGULATORY SUBMISSION | APPROVED |
---|---|---|---|---|---|---|
Doxorubicin | ANDA | Ovarian Cancer | ||||
Amphotericin B | ANDA | Fungi | ||||
MS01 | ANDA | Acromegaly | ||||
MS02 | ANDA | Schizophrenia | ||||
FDL001 | 505(b)(2) | Nausea, Vomiting | ||||
FDL002 | 505(b)(2) | Fungi | ||||
FDLC001 | 505(b)(2) | Chronic Pain | ||||
FDLC002 | 505(b)(2) | Chronic Pain | ||||
FDM001 | 505(b)(2) | Women's Health | ||||
FDM002 | 505(b)(2) | Chronic Pain |