Vertical Pharmaceuticals, LLC
Overview
Vertical Pharmaceuticals, LLC is a specialty pharmaceutical company that is focused on the development, manufacturing, and commercialization of prescription products. The company operates as a subsidiary of Osmotica Pharmaceuticals plc, which focuses on central nervous system and women's health therapeutic areas.
Therapeutic areas
API / Drug Master Files
Vertical Pharmaceuticals, LLC holds 2 active (2 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.
- DYCLONINE HYDROCHLORIDE USPActive2015-02-18
- LWJXS APIActive2015-01-19
FDA compliance signals
8 FDA enforcement records linked to this company.
- 4832018-07-18
Late submission of quarterly safety reports
- warning_letter2017-05-10
FDA Warning Letter (drug product)
- 4832016-11-01
Interval
- 4832016-11-01
Failure to review ADE information
- 4832016-11-01
Late submission of 15-day report
- 4832016-11-01
Failure to develop written procedures
- 4832016-11-01
Timely submission
- warning_letter2010-02-18
FDA Warning Letter (drug product)
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