Paliperidone 6-Month IM Injection 1,092 mg, 1,560 mg Suppliers & Bulk Manufacturers

Available Forms: Once-6-Month IM Injection

Available Strengths: 1,092 mg, 1,560 mg

Reference Brands: Invega Hafyera®(US)

Category: Antipsychotropic Drugs

Paliperidone palmitate six-month extended-release injectable suspension, 1,092 mg and 1,560 mg prefilled syringes, for maintenance in schizophrenia. For mental health services, hospital buyers and licensed importers.

Product Description:

Paliperidone is an atypical antipsychotic and the active metabolite of risperidone. It blocks dopamine D2 and serotonin 5-HT2A receptors. Here it is present as paliperidone palmitate, an ester that dissolves very slowly from muscle, so one gluteal injection keeps levels steady for six months. The strengths, 1,092 mg and 1,560 mg, are stated as the palmitate; some labels give the same doses as 700 mg and 1,000 mg paliperidone. It is an extended-release aqueous suspension in a prefilled syringe.

The six-month injection is for maintenance in adults with schizophrenia already stable on monthly or three-monthly paliperidone palmitate. It is never used to start treatment, and the label sets how long a patient must first be on the shorter-acting product and how doses convert. A healthcare professional gives it into the gluteal muscle only. The syringe needs vigorous shaking just before use because the suspension settles. Prescribers watch for extrapyramidal effects, raised prolactin, weight gain and QT prolongation. It carries the antipsychotic warning on mortality in elderly patients with dementia-related psychosis.

Sourcing notes. Long-acting injectable suspensions are complex products, and regulators expect more than a standard generic file. The CTD dossier should cover particle size distribution, resuspendability, syringe and needle components and any pharmacokinetic evidence the authority requires. Confirm that the six-month strength is approved in your market. It is stored at controlled room temperature, without a cold chain. Ask for a CoA per batch, a sterile-manufacture GMP certificate, a CoPP and the instructions for use. It is prescription-only. Specify strength, kit contents, quantity and market.