WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Cosentyx (secukinumab) is licensed by the FDA for plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, enthesitis-related arthritis and hidradenitis suppurativa, and every presentation ships as a refrigerated 2-8C biologic.

Cosentyx (secukinumab) is Novartis's IL-17A inhibitor, supplied through licensed Indian distribution channels rather than generic manufacture, since it remains an originator biologic. M Care sources Sensoready pens, UnoReady pens and prefilled syringes for hospital pharmacies, dermatology clinics and MoH tender desks, and manages the validated cold chain from dispatch to destination port.

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WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Secukinumab exporter and bulk supplier from India.

For tender and bulk hospital orders, M Care coordinates batch-matched Cosentyx consignments from licensed Indian distribution channels, with cold-chain validated lanes (2-8C throughout) and full batch documentation for MoH and NGO procurement desks. Quantities are confirmed against current allocation from the originator's authorised distribution network, so buyers should share expected order volumes and destination-country import requirements early to lock in dispatch slots.

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.

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At a glance

Interleukin-17A (IL-17A) antagonist, human monoclonal antibody, sourced and documented for export.

Secukinumab is a fully human monoclonal antibody that selectively binds and neutralises interleukin-17A (IL-17A), a cytokine central to the inflammatory cascade in psoriatic disease and axial spondyloarthritis. It does not target IL-17F or other IL-17 family members.

FDA-licensed indications are: moderate to severe plaque psoriasis in adults and paediatric patients aged 6 years and older who are candidates for systemic therapy or phototherapy; active psoriatic arthritis in adults and paediatric patients aged 2 years and older; active ankylosing spondylitis in adults and paediatric patients aged 12 years and older; active non-radiographic axial spondyloarthritis with objective signs of inflammation in adults; active enthesitis-related arthritis in paediatric patients aged 4 years and older; and moderate to severe hidradenitis suppurativa in adults and paediatric patients aged 12 years and older. Other licensed indications per destination-country labelling may apply in EU and GCC markets.

Cosentyx is a sterile, preservative-free, clear to slightly opalescent, colourless to slightly yellow solution for injection, supplied in single-dose Sensoready pens, UnoReady pens and prefilled syringes. It requires storage at 2-8C, protected from light, in the original carton until use.

Active ingredient

secukinumab. Interleukin-17A (IL-17A) antagonist, human monoclonal antibody.

Forms and strengths

150 mg/mL prefilled syringe; 150 mg/mL Sensoready pen; 300 mg/2 mL UnoReady pen; 300 mg/2 mL prefilled syringe; 75 mg/0.5 mL prefilled syringe.

Indications

Human IL-17A monoclonal antibody licensed for moderate to severe plaque psoriasis, active psoriatic arthritis, active ankylosing spondylitis, active non-radiographic axial spondyloarthritis, active enthesitis-related arthritis, and moderate to severe hidradenitis suppurativa (including paediatric hidradenitis suppurativa in patients 12 years and older).

Administration

subcutaneous. Solution for injection in single-dose Sensoready pen, UnoReady pen and 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.

Who we supply

Hospital pharmacies, licensed importers and tender desks across our export markets.

India is our origin. We do not sell into the Indian market.

Buyers for Cosentyx typically include dermatology and rheumatology departments at private and NHS-equivalent hospitals, specialty pharmacy chains, MoH tender desks running biologic formulary lines across the GCC and Africa, and licensed importers building a psoriasis or spondyloarthritis treatment portfolio. Because the product is an originator biologic, buyers usually need pharmacy or hospital-level cold storage and biologic handling licensure already in place before M Care confirms a dispatch schedule.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on secukinumab.

Dosing follows an induction-then-maintenance pattern that varies by indication. For plaque psoriasis, psoriatic arthritis and ankylosing spondylitis, the standard adult regimen is 300 mg subcutaneously at Weeks 0, 1, 2, 3 and 4, followed by 300 mg every 4 weeks; some patients (150 mg starting dose, or PsA patients without concomitant moderate to severe plaque psoriasis) may use 150 mg. For hidradenitis suppurativa, the label allows 300 mg every 4 weeks, with an option to increase to every 2 weeks for patients with an inadequate response. Paediatric enthesitis-related arthritis follows a separate weight-based regimen. Confirm the indication-specific regimen against the current label before dispensing, since starting doses differ across indications.

Cosentyx is preservative-free, so each pen or syringe is single-use only; discard any unused portion. Allow the Sensoready pen and the 150 mg/mL and 75 mg/0.5 mL prefilled syringes to reach room temperature for 15 to 30 minutes before injection; the UnoReady pen and the 300 mg/2 mL prefilled syringe need 30 to 45 minutes. This reduces injection-site discomfort. Do not shake the pen or syringe.

Cold chain is the operational detail buyers most often underestimate: every Cosentyx presentation, Sensoready pen, UnoReady pen and prefilled syringes alike, must stay at 2-8C, protected from light, from dispatch through to point of use. For the Sensoready pen and the 150 mg/mL and 75 mg/0.5 mL prefilled syringes, the label permits a single out-of-fridge window of up to 4 days at room temperature (up to 30C) if needed for patient travel, with the removal date recorded on the carton, but repeated excursions are not validated and risk product integrity. M Care's cold-chain lanes are built around continuous 2-8C transit, not the emergency room-temperature allowance.

There is no FDA-licensed biosimilar to secukinumab at present. Pharmacists should not expect an interchangeable product; supply planning should assume Cosentyx as the sole IL-17A option in this class unless a biosimilar receives FDA licensure, which has not yet occurred.

Regulatory & quality

The documentation pack a regulator actually asks for.

As a refrigerated biologic, Cosentyx moves through M Care's cold-chain validated lanes with continuous temperature logging from the Indian distribution point to the destination cold room, alongside batch release documentation, certificates of analysis and CTD/eCTD-format dossier support where a destination regulator requires it for import registration. M Care holds CDSCO export licensure for outbound shipment from India; the underlying manufacturing and marketing authorisation for Cosentyx sits with Novartis, not with M Care.

Because secukinumab remains a patented originator biologic with no FDA-licensed biosimilar on the market, buyers are sourcing Cosentyx itself rather than choosing between brand and biosimilar. M Care supplies it through licensed Indian distribution channels of the originator, and does not claim to manufacture, hold WHO-GMP or WHO-PQ status, or represent Novartis in any territory.

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.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for secukinumab.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Secukinumab supply, the specific questions.

Is there a generic or biosimilar version of Cosentyx (secukinumab)?

No. Secukinumab remains under patent protection in major markets and no FDA-licensed biosimilar exists for it at present, unlike some other biologics in the anti-inflammatory class. Buyers should plan sourcing around Cosentyx as the branded product, supplied through licensed Indian distribution channels rather than generic manufacture.

Can M Care supply Cosentyx to my country?

M Care sources Cosentyx through licensed Indian distribution channels and dispatches on a cold-chain validated basis to its served export markets. Import is always on the basis of the destination country's own registration and import permit requirements; confirm your country's current registration status with the Mumbai desk when raising an enquiry.

How is cold chain managed for Cosentyx shipments?

Cosentyx pens and prefilled syringes require continuous 2-8C storage, protected from light, from dispatch to point of use. M Care runs cold-chain validated lanes with temperature logging for the full transit, and provides batch documentation confirming the chain was maintained on arrival.

What indications is Cosentyx licensed for?

The FDA label covers moderate to severe plaque psoriasis (adults and paediatric patients 6 years and older), active psoriatic arthritis (adults and paediatric patients 2 years and older), active ankylosing spondylitis (adults and paediatric patients 12 years and older), active non-radiographic axial spondyloarthritis in adults, active enthesitis-related arthritis (paediatric patients 4 years and older), and moderate to severe hidradenitis suppurativa (adults and paediatric patients 12 years and older). Destination-country labelling may list additional or differently worded indications.

What presentations does Cosentyx come in?

Cosentyx is supplied as a preservative-free solution for subcutaneous injection in single-dose Sensoready pens, UnoReady pens and prefilled syringes. Each device is single-use; unused product must be discarded rather than reused.

What dosing schedule should we plan formulary stock around?

Most adult indications use a 300 mg induction regimen at Weeks 0, 1, 2, 3 and 4, followed by 300 mg every 4 weeks; hidradenitis suppurativa allows every-2-week maintenance for inadequate responders, some patients use 150 mg, and paediatric enthesitis-related arthritis follows a separate weight-based regimen. Confirm the indication-specific regimen against the current label, since starting doses are not uniform across the six licensed indications.

Sources and review

Who stands behind this page, and where its statements come from.

Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-28.

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.

Secukinumab enquiry

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