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Medicine

Comirnaty injectable suspension

Covid-19 vaccine, mrna · Intramuscular · Pfizer Laboratories
Available on requestPrescription onlyUS FDA

Comirnaty injectable suspension is a prescription medicine containing Covid-19 vaccine, mrna for intramuscular 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

Storage as on the product label

Key facts

Active ingredient (INN)
Covid-19 vaccine, mrna
Brand
Comirnaty
Dosage form
Injectable suspension
Route
Intramuscular
Packs
10 vials, 10 syringes and 1 more
Marketing authorisation holder
Pfizer Laboratories
Manufacturer
Pfizer Laboratories
Origin register
US FDA, United States
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
HS code (indicative)
3002.41Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
27 August 2025
Identifiers
NDC 0069-2501, 0069-2631, 0069-2609 +1Application BLA125742

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
10 vial, single-dose in 1 carton / .48 mL in 1 vial, single-dose0069-2501-10Pfizer Laboratories27 August 2025
10 syringe, glass in 1 carton / .418 mL in 1 syringe, glass0069-2528-10Pfizer Laboratories27 August 2025
10 vial, single-dose in 1 carton / .48 mL in 1 vial, single-dose0069-2609-10Pfizer Laboratories27 August 2026
10 syringe, glass in 1 carton / .418 mL in 1 syringe, glass0069-2631-10Pfizer Laboratories27 August 2026

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
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

Alternatives

Other makers and brands of Covid-19 vaccine, mrna injectable suspension.

Compare all 2

Clinical summary

Clinical information for Covid-19 vaccine, mrna is on its overview page.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Covid-19 vaccine, mrna

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

Data sources

  • US FDA NDC directory · Checked 12 November 2026

Need Comirnaty 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.