Medicine
Invega Hafyera 1560 mg/5 mL extended-release injectable suspension
Invega Hafyera 1560 mg/5 mL extended-release injectable suspension is a prescription medicine containing Paliperidone palmitate for intramuscular use, marketed by Janssen Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at room temperature 20 °C to 25 °C (68 °F to 77 °F), excursions between…
Key facts
- Active ingredient (INN)
- Paliperidone palmitate
- Brand
- Invega Hafyera
- Strength
- 1560 mg/5 mL
- Dosage form
- Extended-release injectable suspension
- Route
- Intramuscular
- Packs
- 1 syringe of 5 mL
- Marketing authorisation holder
- Janssen Pharmaceuticals
- Manufacturer
- Janssen Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at room temperature 20 °C to 25 °C (68 °F to 77 °F), excursions between 15 °C and 30 °C (59 °F and 86 °F) are permitted. Ship and store in a horizontal position.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 August 2021
- Identifiers
- RxCUI 2570418, 2570419, 2570420 +1DailyMed set ID 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0bNDC 50458-612Application NDA207946
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 syringe in 1 carton / 5 mL in 1 syringe | 50458-612-01 | Janssen Pharmaceuticals | 30 August 2021 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 31 July 2009 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Paliperidone palmitate
Clinical summary
Paliperidone palmitate is an atypical antipsychotic indicated for the treatment of schizophrenia in adults. It is available as injection and extended-release injectable suspension for intramuscular use. MedsAcross supplies Paliperidone palmitate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Paliperidone palmitateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- INVEGA SUSTENNA prescribing information (Janssen Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Invega Hafyera 1560 mg/5 mL extended-release injectable suspension for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.