Medicine
Ganirelix 250 mcg/0.5 mL injection
Ganirelix 250 mcg/0.5 mL injection is a generic prescription medicine for subcutaneous use, made by 3 labelers, 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 at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Ganirelix
- Brand
- Sold under the generic name
- Strength
- 250 mcg/0.5 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 0.5 mL, 1 blister pack of 0.5 mL
- Manufacturers
- Amphastar PharmaceuticalsMeitheal PharmaceuticalsMullan Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- H01CC01 Ganirelix
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 June 2022
- Identifiers
- RxCUI 855200DailyMed set ID 420ce739-2756-4fb4-8a4e-5fab501ab973, 9c286f64-8039-44ec-8fdd-d1a2f52b4c3c, 1f067dfb-f9c7-4020-ab7b-da2ba695ab32NDC 83301-0082, 0548-5001, 71288-554Application ANDA218855, ANDA212613, ANDA214996
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 syringe in 1 carton / .5 mL in 1 syringe | 0548-5001-00 | Amphastar Pharmaceuticals | 20 June 2022 |
| 1 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / .5 mL in 1 syringe, glass | 71288-554-80 | Meitheal Pharmaceuticals | 6 June 2022 |
| 1 syringe, glass in 1 carton / .5 mL in 1 syringe, glass | 83301-0082-1 | Mullan Pharmaceutical | 5 May 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.
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 Ganirelix 250 mcg/0.5 mL injection.
Other strengths and forms of Ganirelix
Clinical summary
Ganirelix is a gonadotropin releasing hormone receptor antagonist indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation. It is available as injection for subcutaneous use. MedsAcross supplies Ganirelix 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 GanirelixFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ganirelix Acetate prescribing information (Organon) · U.S. National Library of Medicine, DailyMed
- Orgalutran: European public assessment report (EPAR) · European Medicines Agency
- Ganirelix Gedeon Richter: European public assessment report (EPAR) · European Medicines Agency
Need Ganirelix 250 mcg/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.