Tirzepatide, sold as Mounjaro for diabetes and Zepbound for weight management, remains under patent in every major market into the mid-2030s, so there is no generic to source, only licensed-brand supply chains to verify.
Tirzepatide is a first-in-class dual GIP/GLP-1 receptor agonist under patent in the United States, European Union and United Kingdom into the mid-2030s, with device and formulation patents reaching further still. There is no legitimate generic on the market: only two Eli Lilly brands exist, Mounjaro (type 2 diabetes, and in the EU/UK also weight management) and Zepbound (weight management, United States only). M Care Exports sources finished, licensed product against each buyer's own registered label and destination market, not through any compounding or unlicensed route.
Tirzepatide exporter and bulk supplier from India.
Tirzepatide moves as a cold-chain pharmaceutical: single-dose pens and vials require storage at 2 to 8 degrees C and are validated for a single, non-repeatable 21-day excursion at room temperature up to 30 degrees C, after which the product must be discarded regardless of whether it returns to refrigeration. Export consignments are packed with qualified insulated shipping and temperature loggers, timed to the buyer's cold-chain receiving capacity, since the room-temperature allowance cannot be reset once used. Because tirzepatide has no generic status anywhere, every quotation is for licensed Mounjaro or Zepbound product against the buyer's own import permit, destination marketing authorisation or named-patient approval, batch documentation and certificate of analysis traceable to the originating licensed manufacturer. Availability of a specific strength or pack is confirmed against each enquiry.
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.
Dual GIP/GLP-1 receptor agonist (twincretin), sourced and documented for export.
Tirzepatide is Eli Lilly's first-in-class dual GIP/GLP-1 receptor agonist, patented into the mid-2030s across the United States, European Union and United Kingdom, with additional device and formulation patents reported to extend further still. No generic or biosimilar tirzepatide is legally available in any of these markets today. Clinically, it activates two incretin receptor pathways rather than one, distinguishing it mechanistically from single-agonist GLP-1 therapies. It is approved for type 2 diabetes as Mounjaro, and for chronic weight management (including, in the United States, moderate to severe obstructive sleep apnoea in adults with obesity) as Zepbound in the US, or as Mounjaro in the EU and UK, where one brand covers both indications. Dosing is a once-weekly subcutaneous injection, titrated from a 2.5 mg starting dose across six available strengths up to a 15 mg maintenance ceiling, individualised to tolerability and glycaemic or weight response.
Active ingredient
Tirzepatide. Dual GIP/GLP-1 receptor agonist (twincretin).
Forms and strengths
2.5 mg/0.5 mL; 5 mg/0.5 mL; 7.5 mg/0.5 mL; 10 mg/0.5 mL; 12.5 mg/0.5 mL; 15 mg/0.5 mL.
Indications
Tirzepatide is a once-weekly subcutaneous dual GIP/GLP-1 receptor agonist, marketed as Mounjaro for type 2 diabetes and, in the United States, as Zepbound for chronic weight management and moderate to severe obstructive sleep apnoea in adults with obesity. In the European Union and United Kingdom, the Mounjaro brand alone covers both the diabetes and weight-management indications under one marketing authorisation.
Administration
Subcutaneous injection. Solution for injection: single-dose prefilled pen, single-dose vial, and multi-dose vial.
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.
Demand for tirzepatide comes from licensed importers, hospital and specialty pharmacy procurement, endocrinology and bariatric tender desks, and national or private insurance formulary buyers across the United Kingdom, the European Union, Gulf Cooperation Council states, Southeast Asia and other markets, wherever Mounjaro or Zepbound is registered or accessible through named-patient or parallel-import routes. Buyers are typically re-exporters and distributors serving diabetes and metabolic disease clinics, weight-management centres operating under medical supervision, and hospital pharmacy networks building GLP-1 receptor agonist formulary lines. Because both brands carry active safety monitoring requirements and structured care obligations in several markets, buyers are almost always licensed pharmaceutical entities rather than direct retail channels; M Care does not supply patients or unlicensed retailers.
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 tirzepatide.
A receiving pharmacist should confirm the product is Mounjaro or Zepbound exactly as registered on the destination label, since the same molecule carries different approved indications and, in the EU/UK, a single brand covers both. Both carry a boxed warning for thyroid C-cell tumours observed in rodent studies, contraindicated in patients with a personal or family history of medullary thyroid carcinoma or MEN 2 syndrome; this belongs in receiving and formulary documentation, not only the outer carton. Because tirzepatide slows gastric emptying, interaction review should flag oral medicines with narrow therapeutic index or where absorption timing matters. Device verification matters at receipt: single-dose pens, single-dose vials and multi-dose vials all exist at overlapping strengths, and the correct device and strength combination must match the buyer's registered SKU. Cold-chain integrity on arrival, confirmed against the shipment's temperature log rather than assumed, determines whether the single 21-day room-temperature allowance has already been partly or fully consumed in transit.
The documentation pack a regulator actually asks for.
Every tirzepatide consignment is quoted against the buyer's own destination marketing authorisation or import permit for Mounjaro or Zepbound, since no generic registration exists anywhere to substitute against. The documentation pack includes batch-specific certificate of analysis, certificate of origin, and a certificate of pharmaceutical product or free sale certificate from the market where the batch was released, alongside cold-chain packing validation and temperature logger data covering the transit period. M Care Exports operates as a licensed merchant-exporter under ISO 9001:2015 quality management and a CDSCO export licence, sourcing finished Mounjaro and Zepbound stock through authorised licensed distribution channels rather than manufacturing or repackaging any product itself. Because tirzepatide remains under active compound, formulation and device patent in every major destination market, buyers should expect to source against the originator's own registered dossier and should not request or accept documentation implying generic or unlicensed equivalence, a distinction regulatory affairs teams should confirm at the enquiry stage rather than at customs.
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.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Tirzepatide (Mounjaro, Zepbound) is a prescription-only medicine in all served markets; M Care supplies licensed importers, pharmacies and healthcare procurement only, not patients or unlicensed retail.
Both brands carry a boxed warning for thyroid C-cell tumours identified in rodent studies and are contraindicated in patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.
No generic or biosimilar tirzepatide holds legal marketing authorisation in the United States, European Union or United Kingdom; core and formulation patents are reported to run into the mid-2030s and beyond.
Product requires continuous cold-chain storage at 2 to 8 degrees C, with a single, non-repeatable 21-day room-temperature allowance up to 30 degrees C.
Compounded or unlicensed tirzepatide is not manufactured, sourced or supplied by M Care Exports under any circumstance; only finished, licensed Mounjaro or Zepbound is supplied.
M Care Exports is a merchant-exporter, not a manufacturer, and does not hold WHO-GMP or WHO-PQ certification; its own credentials are ISO 9001:2015 and a CDSCO export licence.
Adjacent lines procurement desks order alongside tirzepatide.
Dapagliflozin metformin
Another diabetes & endocrine line ordered on the same formularies.
Gliclazide
Another diabetes & endocrine line ordered on the same formularies.
Glimepiride
Another diabetes & endocrine line ordered on the same formularies.
All diabetes & endocrine
The full category listing for procurement desks.
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 tirzepatide.
- 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.
Tirzepatide supply, the specific questions.
What is the real difference between Mounjaro and Zepbound if the active ingredient is identical?
Mounjaro and Zepbound both contain tirzepatide at the same six strengths, but they carry different approved indications and, in the United States, separate brand registrations: Mounjaro for type 2 diabetes, Zepbound for chronic weight management, including moderate to severe obstructive sleep apnoea with obesity. In the European Union and United Kingdom, Mounjaro alone covers both indications under one marketing authorisation. Buyers must quote against the brand registered for their destination market and intended indication.
Is generic tirzepatide available to import?
No. Tirzepatide's core compound patent is reported to run into the mid-2030s in the United States, European Union and United Kingdom, with additional device and formulation patents reported to extend further. No generic or biosimilar tirzepatide holds legal marketing authorisation in any major destination market at present. Every legitimate quotation is for licensed Mounjaro or Zepbound product sourced through authorised distribution, not a generic equivalent.
Why does M Care specify licensed product rather than compounded tirzepatide?
During a 2022 to 2024 US supply shortage, compounding pharmacies were permitted to prepare copies of tirzepatide under narrow exemptions. The FDA declared the shortage resolved in December 2024 and required mass compounding to wind down by February to March 2025. Compounded product was never FDA-reviewed for potency or purity, and some tested batches were found to contain impurities or non-approved forms. M Care supplies only finished, licensed Mounjaro or Zepbound, with batch documentation traceable to the originator's own release.
What makes tirzepatide mechanistically different from single-agonist GLP-1 products?
Tirzepatide is a dual agonist, activating both the GIP and GLP-1 incretin receptors, whereas single-agonist products activate GLP-1 alone. Regulatory affairs and formulary teams sometimes need this distinction to justify a tender submission or comparator dossier, since the two drug classes are approved under separate applications with their own trial data and are not interchangeable substitutes on a formulary line.
What are the storage and shipping requirements for tirzepatide?
Tirzepatide pens and vials must be stored at 2 to 8 degrees C. An unopened pen or vial may be held at room temperature, up to 30 degrees C, for a single non-repeatable period of 21 days, after which it must be discarded regardless of whether it is returned to refrigeration. Export shipments are packed and logged accordingly, and buyers should confirm their receiving cold-chain capacity before that window is consumed in transit.
Can M Care supply tirzepatide into a market where Mounjaro or Zepbound is not yet registered?
Where a destination market has no local marketing authorisation, supply typically proceeds through a named-patient or parallel-import route rather than open market sale, subject to the buyer's own import permit and the destination regulator's own procedure. M Care supports these enquiries through its named-patient and specialty import service and quotes against the buyer's specific permit rather than assuming standard registration exists.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter, not a manufacturer, and does not hold WHO-GMP or WHO-PQ certification itself. Its own credentials are ISO 9001:2015 quality management and a CDSCO export licence. Tirzepatide is manufactured solely by the originator company under that company's own regulator-inspected facilities; M Care sources finished Mounjaro and Zepbound stock through licensed distribution channels and supplies against the buyer's own registered import documentation.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
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.
Send the specifics. You'll have a price inside one working day.
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