Aspen Oss B.V.
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- Netherlands
- Registered address
- Kloosterstraat 6, Oss, 5349AB, Netherlands (NLD)
- Operations here
- analysisapi manufacturemanufacturepacksterilize
- FDA identifiers
- FEI 3010414279 · DUNS 491013870
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-11-24
- VAIDrug Quality Assurance2019-09-13
- NAIDrug Quality Assurance2014-09-25
Drugs this plant is listed as making
7 distinct drugs across 9 products name this site in their FDA label.
- desogestrel and ethinyl estradiolApotex Corp.
- Drospirenone and Ethinyl Estradiol TabletsXiromed, LLC.
- Levonorgestrel and Ethinyl EstradiolXiromed, LLC.
- NorethindroneApotex Corp.
- norgestimate and ethinyl estradiolXiromed, LLC.
- TestosteroneCipla USA Inc.
- testosterone cypionateCipla USA Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.