HOVIONE PHARMASCIENCE LTD
Overview
HOVIONE PHARMASCIENCE LTD is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering DOXYCYCLINE HYCLATE; IVERMECTIN USP; KB01; SALMETEROL XINAFOATE MICRONIZED.
Core services & business areas
Active ingredients with DMF or CEP filings
Substances for which HOVIONE PHARMASCIENCE LTD holds, or has held, a US FDA Drug Master File or an EU CEP. A filing is not proof of current supply. Open any ingredient to see all its holders, CAS number and product patent dates.
API / Drug Master Files
HOVIONE PHARMASCIENCE LTD holds 4 active (5 total) FDA Type II Drug Master Files. A Type II DMF is filed with the FDA to support an active ingredient in drug applications; an active filing can be referenced but is not proof of current supply, and inactive filings are historical.
- SALMETEROL XINAFOATE MICRONIZEDActive2018-05-30
- KB01Active2009-03-27
- IVERMECTIN USPActive2008-03-05
- DOXYCYCLINE HYCLATEActive1998-09-01
- GLYCOPYRROLATE INHALATION GRADEInactive2016-11-29
FDA compliance signals
No FDA recalls, Warning Letters, or Form 483 observations are linked to HOVIONE PHARMASCIENCE LTD in our records. Events are linked by company name and identifier, so this is not proof that none exist; check the FDA's own databases before relying on it.
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