Paliperidone Palmitate
Overview
Paliperidone Palmitate is a long-acting injectable atypical antipsychotic used in the treatment of schizophrenia. It is an ester of paliperidone, which is the primary active metabolite of risperidone.
API suppliers (8)
Suppliers of Paliperidone Palmitate evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
Country recorded for 7 of 8 suppliers.
5 of 8 hold a GMP certificate on record in the EU or UK registers
- Neuland Laboratories LimitedIndia1 active DMF
- JUBILANT BIOSYS LTDIndia1 active DMF
- MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
- Piramal Pharma LimitedIndia1 active DMF GMP on record
- INTERQUIM SAPeru1 active DMF GMP on record
- APITORIA PHARMA PRIVATE LTDIndia1 active DMF GMP on record
- Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
- DR REDDYS LABORATORIES LTD1 active DMF GMP on record
Patent & exclusivity (US)
Per the FDA Orange Book (17 approved US products), the latest listed US patent on Paliperidone Palmitate expires 24 Nov 2041. Generic API sourcing typically opens up once these lapse.
Therapeutic areas
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