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OVERVIEW
- Facility area:
- Regulatory approval:
- U.S. FDA
- U.S. DEA
- MHRA (UK)
Click here to read White Paper on “Contract Manufacturing in Puerto Rico”
Manatí Operations, Puerto Rico, specializes in the high volume commercial manufacture of solid dosage forms including tablets, capsules, and powders packaged in bottles.
The high-quality site comprises three separate manufacturing areas each with separate HVAC systems. The facility’s environmental controls and ventilation systems facilitate explosion-proof manufacturing, including solvent coating of tablets. This flexible facility also has a low-humidity manufacturing suite for moisture-sensitive tablet formats.
Manatí Operations carries a U.S. DEA manufacturing registration (Schedule III-N and IV) and an analytical registration (Schedule II, III, III-N to V) for controlled drugs in the U.S.
In addition to its solid dosage form specialization, Manatí Operations also offers capabilities in the manufacture of controlled release technologies, including those utilizing pelletization, matrix and coating strategies.