Omvoh (mirikizumab) is an IL-23p19 antibody for ulcerative colitis and Crohn's disease, given as an IV induction at weeks 0, 4 and 8 and then as subcutaneous pens or syringes every 4 weeks, and it needs a cold chain.
M Care Exports supplies Omvoh (mirikizumab), marketed by Eli Lilly, to hospital pharmacies, gastroenterology units, importers and tender desks in the GCC, Africa and the UK. If you are looking for the 300 mg IV vial or the 100 mg and 200 mg subcutaneous pens and syringes, send the destination, the presentation and the quantity, and we quote per destination.
Mirikizumab exporter and bulk supplier from India.
"We need a partner for Omvoh" is a typical enquiry from a hospital gastroenterology pharmacy or a tender desk. M Care is a merchant-exporter: we quote against your specification and confirm which presentations your destination registers. Omvoh is not one line but two. The 300 mg/15 mL vial is for IV induction only, and the subcutaneous maintenance comes as separate 100 mg/mL and 200 mg/2 mL pens and prefilled syringes. The US label supplies the subcutaneous packs by indication: ulcerative colitis cartons hold two 100 mg units or one 200 mg unit, and Crohn's disease cartons hold one 100 mg and one 200 mg unit. A Crohn's disease course therefore needs the induction vials and the Crohn's maintenance cartons, ordered as different lines. Every presentation is refrigerated at 2 to 8 °C, so the quote also turns on cold-chain packing, the registration route in the destination and Incoterms.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Interleukin-23 (IL-23p19) antagonist monoclonal antibody for ulcerative colitis and Crohn's disease, sourced and documented for export.
Omvoh is an interleukin-23 (IL-23) antagonist, a monoclonal antibody against the p19 subunit, for adults with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD). The US label (Eli Lilly and Company, DailyMed page updated June 2026) lists a 300 mg/15 mL (20 mg/mL) single-dose vial for IV use, and single-dose prefilled pens and prefilled syringes of 100 mg/mL and 200 mg/2 mL for subcutaneous use. For UC the US label gives 300 mg IV over at least 30 minutes at weeks 0, 4 and 8, then 200 mg subcutaneously at week 12 and every 4 weeks (one 200 mg injection or two 100 mg injections). For CD it gives 900 mg IV over at least 90 minutes at weeks 0, 4 and 8, then 300 mg subcutaneously every 4 weeks (one 100 mg and one 200 mg injection). The EMA page lists Eli Lilly Nederland B.V. as the marketing authorisation holder, with authorisation on 26 May 2023, and covers both UC and CD. The UK emc SmPC for the 300 mg concentrate shows the same holder and a first authorisation date of 28 June 2023.
Active ingredient
Mirikizumab (mirikizumab-mrkz in the US). Interleukin-23 (IL-23p19) antagonist monoclonal antibody for ulcerative colitis and Crohn's disease.
Forms and strengths
300 mg/15 mL (20 mg/mL) single-dose vial for IV induction; 100 mg/mL single-dose prefilled pen; 100 mg/mL single-dose prefilled syringe; 200 mg/2 mL single-dose prefilled pen; 200 mg/2 mL single-dose prefilled syringe.
Indications
Mirikizumab (Omvoh) is an IL-23p19 antibody from Eli Lilly for adults with moderately to severely active ulcerative colitis or Crohn's disease, given by IV induction and then subcutaneous maintenance, as set out in the US, EU and UK labelling.
Administration
Intravenous, Subcutaneous. Concentrate for solution for infusion (IV vial); solution for injection in prefilled pen or prefilled syringe.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers are hospital pharmacists in gastroenterology and IBD units, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Omvoh 300 mg vials for an IBD unit" or "We need a partner for mirikizumab pens for a tender". Each destination has its own route to registration or import, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK, and we align the offer with it before quoting. For a biologic like this, whether the destination has registered the product, or needs a named-patient or unlicensed import, depends on the regulator, and M Care Exports confirms the route per enquiry.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on mirikizumab.
Plan the pack list by indication, because UC and CD use different amounts of the same products. The US label gives UC induction as one 300 mg vial per infusion at weeks 0, 4 and 8, and CD induction as 900 mg per infusion, which is three vials each time. The infusion runs at least 30 minutes for UC and at least 90 minutes for CD. Maintenance starts at week 12 and repeats every 4 weeks: 200 mg for UC and 300 mg for CD, built from 100 mg and 200 mg pens or syringes. The vial is diluted before IV use, and the UK SmPC states that the concentrate is for the induction dose only. The US label covers serious hypersensitivity reactions including anaphylaxis during IV infusion, infection risk, tuberculosis evaluation before the first dose, and liver enzyme and bilirubin checks at baseline and for at least 24 weeks. Storage is 2 to 8 °C in the original carton, away from light, never frozen and never shaken. The US label allows a pen or syringe to sit at room temperature up to 30 °C for up to 2 weeks in the carton, and once it has been out it must not go back into the refrigerator.
The documentation pack a regulator actually asks for.
Omvoh is a cold-chain biologic. The US label requires refrigeration at 2 to 8 °C with no freezing or shaking. The US label's room-temperature allowance of up to 2 weeks at up to 30 °C applies to the pen and syringe only, and once a unit has been at room temperature it must not go back into the refrigerator. The UK SmPC for the 300 mg concentrate requires unopened vials at 2 to 8 °C, not frozen and kept in the outer carton away from light, and states no room-temperature allowance for the unopened vial. Export consignments are packed with qualified insulated shippers and temperature loggers, timed to the receiving site. The EMA page shows Omvoh as authorised under additional monitoring. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator asks for it. We state the source and status of each line before quoting, and make no claim for M Care itself beyond merchant-exporter documentation.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside mirikizumab.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for mirikizumab.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Mirikizumab supply, the specific questions.
What decides the landed price of Omvoh for an importer?
We do not publish prices. The landed cost depends on the presentation (300 mg IV vial, or the 100 mg and 200 mg pens and syringes), the pack, the quantity, the registration route in your destination, cold-chain freight and Incoterms. Omvoh is a refrigerated originator biologic, so insulated packing and temperature monitoring are part of the quote. M Care Exports quotes per destination once you send the presentations, volume and country.
Is there a generic or biosimilar of Omvoh, and what is the generic name?
The generic (non-proprietary) name is mirikizumab, and the US label uses mirikizumab-mrkz. In the EMA medicines data, Omvoh from Eli Lilly Nederland B.V. is the only mirikizumab medicine listed, and it is not a biosimilar. DailyMed lists a single mirikizumab label, Omvoh from Eli Lilly and Company, and the UK emc lists only Omvoh products. If you are looking for mirikizumab, M Care Exports confirms the line and its availability for your destination.
What is the Omvoh dose for ulcerative colitis, and what is the 300 mg infusion?
The US label gives 300 mg IV over at least 30 minutes at weeks 0, 4 and 8. The 300 mg is one single-dose vial of 300 mg/15 mL. Subcutaneous maintenance then starts at week 12 and repeats every 4 weeks at 200 mg, as one 200 mg injection or two 100 mg injections. The UK SmPC for the concentrate says the vial is for the induction dose only. Always follow the label of your destination.
How does Omvoh dosing differ in Crohn's disease?
The US label gives 900 mg IV over at least 90 minutes at weeks 0, 4 and 8, which is three 300 mg vials per infusion. Maintenance is 300 mg subcutaneously from week 12 and every 4 weeks, as one 100 mg and one 200 mg injection. The EMA page notes infusions lasting at least 30 minutes for UC and at least 90 minutes for CD. Because the pack count differs from UC, state the indication when you request a quote.
Omvoh vs Skyrizi: how do they compare on the label?
We compare on label facts only and do not recommend one over the other. Omvoh (mirikizumab, Eli Lilly) and Skyrizi (risankizumab-rzaa, AbbVie) both bind the p19 subunit of IL-23, and both US labels cover moderately to severely active ulcerative colitis and Crohn's disease in adults; the Skyrizi label also covers plaque psoriasis and psoriatic arthritis. Omvoh maintenance is every 4 weeks from week 12, while the Skyrizi US label gives 180 mg or 360 mg every 8 weeks from week 12, and its Crohn's induction can be IV or subcutaneous. Doses and devices differ, so check each label for your destination. See the risankizumab (Skyrizi) page.
How is Omvoh stored, is there a room-temperature allowance, and what are the side effects?
Store at 2 to 8 °C in the original carton, protected from light, not frozen and not shaken. The US label allows a pen or syringe up to 30 °C for up to 2 weeks in the carton, and it must not go back in the refrigerator. The UK SmPC states no such allowance for the unopened vial. The EMA lists injection-site reactions as the most common side effect. The US label also covers hypersensitivity including anaphylaxis during infusion, infections, tuberculosis and liver monitoring, so the full label governs use.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-08.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
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