Medicine
Pivya 185 mg tablet
Pivya 185 mg tablet is a prescription medicine containing Pivmecillinam for oral use, marketed by Alembic 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 PIVYA tablets at 20 • C to 25 • C (68 • F to 77 • F), excursions…
Key facts
- Active ingredient (INN)
- Pivmecillinam
- Brand
- Pivya
- Strength
- 185 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 blister pack
- Marketing authorisation holder
- Alembic Pharmaceuticals
- Manufacturer
- Alembic PharmaceuticalsIndia
- Origin register
- US FDA, United States
- Storage
- Store PIVYA tablets at 20 • C to 25 • C (68 • F to 77 • F), excursions permitted between 15°C to 30°C (59°F to 86°F). Store and dispense tablets in the unit-dose blisters.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01CA08 Pivmecillinam
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 February 2026
- Identifiers
- RxCUI 2715865, 2715871DailyMed set ID 440a5f17-ab11-0fc8-e063-6394a90a58e9NDC 62332-966Application NDA216483
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 blister pack in 1 carton / 9 tablet, coated in 1 blister pack | 62332-966-09 | Alembic PharmaceuticalsIndia | 2 February 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 24 April 2024 | 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
Pivmecillinam is a prescription medicine indicated for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. MedsAcross supplies Pivmecillinam 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 PivmecillinamFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PIVYA prescribing information (Alembic Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Pivya 185 mg tablet 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.