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MedsAcross

Medicine

Synarel 2 mg/mL nasal spray

Nafarelin · Nasal · Pfizer Laboratories
Available on requestPrescription onlyUS FDA

Synarel 2 mg/mL nasal spray is a prescription medicine containing Nafarelin for nasal use, marketed by Pfizer Laboratories, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store upright at 25°C (77°F), excursions permitted to 15–30°C (59–86°F)…

Key facts

Active ingredient (INN)
Nafarelin
Brand
Synarel
Strength
2 mg/mL
Dosage form
Nasal spray
Route
Nasal
Packs
1 bottle
Marketing authorisation holder
Pfizer Laboratories
Manufacturer
Pfizer Laboratories
Origin register
US FDA, United States
Storage
Store upright at 25°C (77°F), excursions permitted to 15–30°C (59–86°F). Protect from light. Protect from light.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
H01CA02 Nafarelin
HS code (indicative)
3004.39Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
13 February 1990
Identifiers
RxCUI 1797878, 1797880DailyMed set ID d0aa57cb-d2f4-46d7-af43-7c8b06aa81a6NDC 0025-0166Application NDA019886

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

PackCodeLabelerMarketed since
1 bottle, spray in 1 carton / 8 mL in 1 bottle, spray0025-0166-08Pfizer Laboratories13 February 1990

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 13 February 1990Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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

Clinical summary

Nafarelin is a gonadotropin releasing hormone receptor agonist indicated for treatment of central precocious puberty (CPP) (gonadotropin-dependent precocious puberty) in children of both sexes. It is available as nasal spray. MedsAcross supplies Nafarelin 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 Nafarelin

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Synarel 2 mg/mL nasal spray 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.