Medicine
Hadlima 40 mg/0.8 mL injection
Hadlima 40 mg/0.8 mL injection is a prescription medicine containing Adalimumab for subcutaneous use, marketed by Organon, 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
Storage as on the product label
Key facts
- Active ingredient (INN)
- Adalimumab
- Brand
- Hadlima
- Strength
- 40 mg/0.8 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 2 cartons of 0.8 mL, 1 carton of 0.8 mL, 1 syringe of 0.8 mL and 2 more
- Marketing authorisation holder
- Organon
- Manufacturers
- OrganonA-S Medication Solutions
- Origin register
- US FDA, United States
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AB04 Adalimumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 July 2023
- Identifiers
- RxCUI 2640302, 2640305, 2640287 +1DailyMed set ID 7345f276-102e-4175-b7ef-ff1706b05472, f7f9da92-ff5d-4260-b4bd-e3f6993a36aeNDC 78206-183, 78206-184, 78206-185 +2Application BLA761059
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 |
|---|---|---|---|
| 2 carton in 1 carton / 1 syringe in 1 carton / .8 mL in 1 syringe | 78206-183-01 | Organon | 1 July 2023 |
| 2 carton in 1 carton / 1 syringe in 1 carton / .8 mL in 1 syringe | 78206-184-01 | Organon | 1 July 2023 |
| 1 carton in 1 carton / 1 vial in 1 carton / .8 mL in 1 vial | 78206-185-01 | Organon | 1 July 2023 |
| 1 syringe in 1 carton / .8 mL in 1 syringe | 50090-6705-0 | A-S Medication Solutions | 27 September 2023 |
| 2 syringe in 1 carton / .8 mL in 1 syringe | 50090-8167-0 | A-S Medication Solutions | 26 October 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 Adalimumab 40 mg/0.8 mL injection.
- Amjevita 40 mg/0.8 mL injectionAvailable on requestAmgenUS FDA7 packs Cold chain
- Yusimry 40 mg/0.8 mL injectionAvailable on requestCoherus BioSciencesUS FDA4 packs Cold chain
- Hyrimoz 40 mg/0.8 mL injectionAvailable on requestCordavisUS FDA2 packs Cold chain
- Hadlima 40 mg/0.8 mL injectionAvailable on requestA-S Medication SolutionsUS FDA1 pack
Other strengths and forms of Adalimumab
Clinical summary
Adalimumab is a tumor necrosis factor blocker indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. MedsAcross supplies Adalimumab 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 AdalimumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Humira prescribing information (AbbVie) · U.S. National Library of Medicine, DailyMed
- Humira: European public assessment report (EPAR) · European Medicines Agency
- Amgevita: European public assessment report (EPAR) · European Medicines Agency
Need Hadlima 40 mg/0.8 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.