plecanatide Tablets, immediate release (IR) 3 mg
Dossier type
US CTD
Dossier status
Ready to file
Country of origin
China
Comments
Submission Planned: US
Manufacturer #29288
This hi-tech enterprise specializes in the research and manufacturing of diverse peptide products. Founded in 1998, it has become one of the leading peptide pharmaceutical companies globally, offering a full range of services including finished dosage products, APIs, and CRO/CMO services. Their finished dosage products are primarily sold domestically, while APIs have international distribution. The company operates a GMP-certified manufacturing facility exceeding 1500 sq. m., regularly inspected by local and international authorities. They focus on several key therapy areas, employing various principal dosage forms, including peptide-based formulations.
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