Medicine
Palynziq 10 mg/0.5 mL injection
Palynziq 10 mg/0.5 mL injection is a prescription medicine containing Pegvaliase for subcutaneous use, marketed by BioMarin Pharmaceutical, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store in refrigerator at 36°F to 46°F (2°C to 8°C) in its original carton to…
Key facts
- Active ingredient (INN)
- Pegvaliase
- Brand
- Palynziq
- Strength
- 10 mg/0.5 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 0.5 mL
- Marketing authorisation holder
- BioMarin Pharmaceutical
- Manufacturer
- BioMarin Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Store in refrigerator at 36°F to 46°F (2°C to 8°C) in its original carton to protect from light. Do not freeze or shake. Record the date removed from refrigeration on the carton. Once stored at room temperature, do not return the product to the refrigerator. For patients: If needed, store PALYNZIQ in the original carton at room temperature between 68°F to 77°F (20°C to 25°C) for up to 30 days.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AB19 Pegvaliase
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 May 2018
- Identifiers
- RxCUI 2046365, 2046370, 2046374 +3DailyMed set ID 6dba844a-db02-44f8-8593-ce497ed9406cNDC 68135-756Application BLA761079
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 | 68135-756-20 | BioMarin Pharmaceutical | 24 May 2018 |
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.
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 Pegvaliase
Clinical summary
Pegvaliase is a phenylalanine metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adult and pediatric patients 12 years of age and older with phenylketonuria (PKU), among other approved uses. MedsAcross supplies Pegvaliase 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 PegvaliaseFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Palynziq prescribing information (BioMarin Pharmaceutical) · U.S. National Library of Medicine, DailyMed
- Palynziq: European public assessment report (EPAR) · European Medicines Agency
Need Palynziq 10 mg/0.5 mL injection 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.