Medicine
Pulmozyme 1 mg/mL inhalation solution
Pulmozyme 1 mg/mL inhalation solution is a prescription medicine containing Dornase alfa for inhalation use, marketed by Genentech, 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 PULMOZYME ampules at a refrigerated temperature between 2°C to 8°C (36°F…
Key facts
- Active ingredient (INN)
- Dornase alfa
- Brand
- Pulmozyme
- Strength
- 1 mg/mL
- Dosage form
- Inhalation solution
- Route
- Inhalation
- Packs
- 5 pouches
- Marketing authorisation holder
- Genentech
- Manufacturer
- Genentech
- Origin register
- US FDA, United States
- Storage
- Store PULMOZYME ampules at a refrigerated temperature between 2°C to 8°C (36°F to 46°F) in their protective foil to protect from light and heat. Once the protective foil pouch is opened, the unused ampules must be kept refrigerated in the protective foil pouch to protect from light and heat.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 December 1993
- Identifiers
- RxCUI 205532, 310014DailyMed set ID d8c78a7e-ff99-48f3-8952-643ec2ea0f86NDC 50242-100Application BLA103532
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 |
|---|---|---|---|
| 5 pouch in 1 carton / 6 ampule in 1 pouch / 2.5 mL in 1 ampule | 50242-100-40 | Genentech | 30 December 1993 |
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 30 December 1993 | 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
Clinical summary
Dornase alfa is a recombinant human deoxyribonuclease 1 indicated , in conjunction with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) to improve pulmonary function. MedsAcross supplies Dornase alfa 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 Dornase alfaFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Pulmozyme prescribing information (Genentech) · U.S. National Library of Medicine, DailyMed
Need Pulmozyme 1 mg/mL inhalation solution 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.