Medicine
Lerochol 300 mg/1.2 mL injection
Lerochol 300 mg/1.2 mL injection is a prescription medicine containing Lerodalcibep for subcutaneous use, marketed by LIB Therapeutics, 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 refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to…
Key facts
- Active ingredient (INN)
- Lerodalcibep
- Brand
- Lerochol
- Strength
- 300 mg/1.2 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 1.2 mL
- Marketing authorisation holder
- LIB Therapeutics
- Manufacturer
- LIB Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. If needed, LEROCHOL may be kept at room temperature up to 25°C (77°F) in the original carton and must be used within 3 months of being removed from the refrigerator. Do not shake.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C10AX Cholesterol and lipid-lowering medicines, subgroup C10A, subgroup C10AX
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 December 2025
- Identifiers
- RxCUI 2729467, 2729474DailyMed set ID 422f8b04-6ce8-4e64-a0a9-0ccc9a4a5860, 78c511a3-bc29-4e67-84b1-b966d1391cbfNDC 84685-300Application BLA761427
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 syringe in 1 carton / 1.2 mL in 1 syringe | 84685-300-01 | LIB Therapeutics | 31 March 2026 |
| 1 syringe in 1 carton / 1.2 mL in 1 syringe | 84685-300-02 | LIB Therapeutics | 1 November 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 12 December 2025 | Drugs@FDA |
| EU (EMA) | Opinion | EMA medicines data |
| 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
Lerodalcibep is a prescription medicine indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). It is available as injection for subcutaneous use. MedsAcross supplies Lerodalcibep 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 LerodalcibepFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- LEROCHOL prescribing information (LIB Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Lerochol 300 mg/1.2 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.