RUBICON RESEARCH PRIVATE LTD
Overview
RUBICON RESEARCH PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering COATED DEXTROMETHORPHAN POLISTIREX.
Core services & business areas
API / Drug Master Files
RUBICON RESEARCH PRIVATE LTD holds 1 active (1 total) FDA Type II Drug Master File — 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.
- COATED DEXTROMETHORPHAN POLISTIREXActive2013-09-03
FDA compliance signals
4 FDA enforcement records linked to this company.
- recall — Class III2024-09-25
Discoloration
- recall — Class II2024-06-05
Presence of Foreign Substance: metal in tablet
- recall — Class II2024-05-15
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
- recall — Class II2022-01-19
Complaint received of foreign matter (metal) embedded in tablet.
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