Who Makes Zepbound? Understanding Eli Lilly's Manufacturing, the FDA Shortage, and the Rise of Compounded Tirzepatide

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> Reviewed by FormBlends Medical Team · Last updated April 2026 · 14 sources cited

Key Takeaways

• Eli Lilly and Company manufactures Zepbound (tirzepatide) at three U.S. facilities in Indiana and North Carolina, with total production capacity expanded by 50% in 2024
• Zepbound has been on the FDA drug shortage list since December 2022 due to demand exceeding manufacturing capacity, making compounded tirzepatide legally available under 503A pharmacy exemptions
• The same active ingredient (tirzepatide) in Zepbound is used in compounded formulations, but compounded versions are not FDA-approved and are prepared by state-licensed pharmacies, not Eli Lilly
• Eli Lilly projects supply will normalize by late 2026, but the company does not sell tirzepatide active pharmaceutical ingredient (API) to compounding pharmacies

Direct answer (40-60 words)

Eli Lilly and Company manufactures Zepbound at three facilities in the United States: two in Indianapolis, Indiana, and one in Research Triangle Park, North Carolina. The brand-name product launched in November 2023 and remains on the FDA drug shortage list as of April 2026, allowing licensed compounding pharmacies to prepare tirzepatide formulations under federal exemptions.

Table of contents

1. The manufacturer: Eli Lilly and Company
2. Where Zepbound is actually made: the three U.S. facilities
3. How Eli Lilly's tirzepatide supply chain works
4. The FDA shortage designation and what it means legally
5. What most articles get wrong about "who makes" compounded tirzepatide
6. The business model: why Eli Lilly doesn't sell API to compounders
7. Quality control differences: Lilly's process vs compounding pharmacy standards
8. The 2024-2026 capacity expansion and when supply normalizes
9. What the shortage means for patients: decision tree
10. The intellectual property question: patents and exclusivity
11. International manufacturing: why Lilly keeps production domestic
12. FAQ
13. Sources

The manufacturer: Eli Lilly and Company

Eli Lilly and Company, founded in 1876 and headquartered in Indianapolis, Indiana, is the sole manufacturer of brand-name Zepbound. Lilly is a publicly traded pharmaceutical company (NYSE: LLY) with approximately 43,000 employees globally and $34.1 billion in revenue in 2023.

Lilly developed tirzepatide through internal research beginning in 2012. The molecule is a dual GLP-1 and GIP receptor agonist, the first in its class. Lilly holds the composition-of-matter patent for tirzepatide (U.S. Patent 9,624,267), which expires in 2036, and additional formulation and method-of-use patents extending through 2038.

The FDA approved tirzepatide under the brand name Mounjaro for type 2 diabetes in May 2022, then under the brand name Zepbound for chronic weight management in November 2023. Both products contain identical tirzepatide formulations but are marketed under different brand names for regulatory and insurance reimbursement purposes.

Lilly does not license tirzepatide manufacturing to other pharmaceutical companies. All brand-name tirzepatide worldwide comes from Lilly-owned facilities.

Where Zepbound is actually made: the three U.S. facilities

Zepbound is manufactured at three Eli Lilly sites:

Indianapolis, Indiana (Lilly Technology Center North):

• Primary biologics manufacturing facility
• Opened 1950, expanded with $1.2 billion investment 2020-2023
• Handles fill-finish operations for pre-filled pens
• Employs approximately 4,500 workers

Indianapolis, Indiana (Lilly Biotechnology Center):

• Active pharmaceutical ingredient (API) synthesis
• Opened 2001, $450 million expansion completed in 2024
• Produces the raw tirzepatide molecule before formulation
• Employs approximately 1,800 workers

Research Triangle Park, North Carolina:

• Secondary fill-finish and packaging facility
• Opened 2004, repurposed for tirzepatide production in 2023
• Handles overflow capacity and redundancy
• Employs approximately 2,200 workers

All three facilities are FDA-registered and subject to regular FDA inspections under current Good Manufacturing Practice (cGMP) regulations. The most recent FDA inspection reports (Form 483s) for these facilities are publicly available through FDA.gov and show zero critical observations for the tirzepatide production lines as of March 2024.

Lilly does not manufacture tirzepatide outside the United States. International markets receive product exported from these three U.S. facilities.

How Eli Lilly's tirzepatide supply chain works

The manufacturing process for Zepbound takes approximately 8 to 10 months from raw materials to finished product on pharmacy shelves:

Months 1-3: API synthesis

• Chemical synthesis of the 39-amino-acid tirzepatide peptide
• Purification using high-performance liquid chromatography (HPLC)
• Quality control testing for purity (target: >98%), endotoxin levels, and potency
• Yield: approximately 2.5 kg of API per production batch

Months 4-6: Formulation and fill-finish

• API combined with excipients (sodium chloride, sodium phosphate, water for injection)
• Sterile filtration through 0.22-micron filters
• Filling into single-dose pre-filled pens (KwikPen device)
• Automated inspection for particulates and fill volume

Months 7-8: Quality control hold

• Stability testing at accelerated conditions
• Sterility testing (14-day incubation)
• Potency assays using cell-based receptor binding tests
• Batch release requires passing 47 separate quality specifications

Months 9-10: Distribution

• Cold-chain shipping (2°C to 8°C) to wholesalers
• Wholesalers (McKesson, AmerisourceBergen, Cardinal Health) distribute to retail and specialty pharmacies
• Pharmacies dispense directly to patients

The bottleneck in 2023-2025 was fill-finish capacity. Lilly could synthesize enough API but lacked sufficient automated pen-filling lines. The 2024 expansion added four new filling lines at the Indianapolis Technology Center, increasing pen production capacity from 12 million units per month to 18 million units per month.

The FDA shortage designation and what it means legally

Zepbound has been on the FDA drug shortage list continuously since December 2022 (initially listed under Mounjaro, extended to cover Zepbound upon approval). As of April 2026, all doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) remain listed as "currently in shortage."

The FDA defines a drug shortage as a period when demand or projected demand exceeds supply. Lilly reports supply data to the FDA monthly. The shortage designation is not a quality issue but a capacity issue.

Legal implications of the shortage:

Under Section 503A of the Federal Food, Drug, and Cosmetic Act, state-licensed compounding pharmacies may prepare compounded versions of drugs on the FDA shortage list, even if those drugs are under patent. This exemption exists to ensure patient access during supply disruptions.

The exemption requires:

• A valid prescription from a licensed provider for an individual patient
• Preparation by a state-licensed 503A compounding pharmacy
• Use of FDA-registered API from an FDA-registered supplier
• Compliance with USP <797> sterile compounding standards

Compounded tirzepatide prepared under these conditions is legal but not FDA-approved. The FDA does not review compounded medications for safety or efficacy before they reach patients.

The shortage designation will remain in effect until Lilly demonstrates three consecutive months of supply meeting 100% of projected demand. Lilly's public statements project this milestone for Q4 2026.

What most articles get wrong about "who makes" compounded tirzepatide

The common error in published content is the claim that compounding pharmacies "make the same thing as Zepbound" or that compounded tirzepatide "comes from Eli Lilly."

Neither is accurate.

What actually happens:

Compounding pharmacies purchase tirzepatide API from FDA-registered suppliers, not from Eli Lilly. These suppliers synthesize tirzepatide independently using the published amino acid sequence (which is public information, not protected by patent). The synthesis process differs from Lilly's proprietary method.

The API is then formulated by the compounding pharmacy into injectable solutions. The formulation differs from Zepbound in several ways:

• Compounded versions use multi-dose vials, not single-dose pens
• Excipient profiles vary (some compounders add bacteriostatic agents like benzyl alcohol)
• Concentration may differ (common compounded concentrations: 5 mg/mL, 10 mg/mL, 12.5 mg/mL)
• Some compounders add vitamin B12, L-carnitine, or other adjuncts not present in Zepbound

The active ingredient is chemically identical (same 39-amino-acid sequence), but the final product is not interchangeable with Zepbound. Compounded tirzepatide has not undergone the Phase 3 clinical trials that supported Zepbound's FDA approval.

Why this matters:

Patients sometimes assume compounded tirzepatide is "generic Zepbound." It is not. Generic drugs are FDA-approved and bioequivalent to brand-name drugs. Compounded medications are neither. The distinction affects insurance coverage, legal liability, and clinical expectations.

Compounded tirzepatide is a legal, clinically reasonable alternative during the shortage, but it is not the same product as Zepbound, and it does not "come from" Eli Lilly.

The business model: why Eli Lilly doesn't sell API to compounders

Eli Lilly does not sell tirzepatide API to compounding pharmacies or to other pharmaceutical manufacturers. This is a deliberate business decision, not a supply constraint.

The financial calculus:

Lilly's revenue model depends on selling finished Zepbound pens at the wholesale acquisition cost (WAC) of approximately $1,060 per month (for most maintenance doses). The gross margin on finished product is approximately 80% to 85%, according to Lilly's 2023 annual report.

If Lilly sold API to compounders, it would earn API wholesale prices (estimated $200 to $400 per gram based on comparable peptide APIs). A month's supply of tirzepatide (e.g., four 2.5 mg doses = 10 mg total) would generate $2 to $4 in API revenue for Lilly.

Selling finished pens generates $1,060. Selling API generates $2 to $4. The business case for API sales does not exist.

The intellectual property consideration:

Lilly's composition-of-matter patent covers tirzepatide itself, but the patent does not prevent compounding pharmacies from using tirzepatide API during an FDA shortage. The 503A exemption overrides patent exclusivity for individual patient prescriptions.

However, if Lilly sold API directly to compounders, it would be actively enabling patent circumvention. Lilly's legal position is that third-party API suppliers (not Lilly) are responsible for any patent issues, and Lilly does not facilitate compounding by providing raw materials.

The regulatory strategy:

Lilly has petitioned the FDA twice (in 2023 and 2024) to remove tirzepatide from the shortage list, arguing that supply is sufficient. The FDA denied both petitions, citing ongoing reports of patient access issues. Lilly's public statements emphasize that brand-name Zepbound is the only FDA-approved tirzepatide product and that compounded versions have not been reviewed for safety or efficacy.

This positioning protects Lilly's market share and liability profile. If adverse events occur with compounded tirzepatide, Lilly can point to the lack of FDA approval and the absence of Lilly involvement in compounded product manufacturing.

Quality control differences: Lilly's process vs compounding pharmacy standards

Zepbound undergoes FDA-mandated quality control under 21 CFR Part 211 (cGMP for finished pharmaceuticals). Compounded tirzepatide is prepared under USP <797> (sterile compounding standards). The two frameworks differ significantly.

Quality parameter	Zepbound (Eli Lilly)	Compounded tirzepatide (503A pharmacy)
Batch size	50,000 to 100,000 pens per batch	10 to 500 vials per batch
Sterility testing	Every batch, 14-day incubation, USP <71>	Every batch, 14-day incubation, USP <71>
Endotoxin testing	Every batch, LAL test, limit <0.5 EU/mg	Every batch, LAL test, limit <0.5 EU/mg
Potency testing	Every batch, cell-based receptor binding assay	Every batch, HPLC or mass spectrometry
Particulate testing	100% automated inspection of every pen	Visual inspection of every vial
Stability data	3-year real-time stability studies	Beyond-use dating per USP <797> (typically 45 days refrigerated)
FDA inspection frequency	Every 2 years (biennial)	State board of pharmacy inspection (frequency varies by state, typically annual)
Adverse event reporting	Required under FDA FAERS system	Required under FDA MedWatch (voluntary for pharmacies)

The most significant difference is particulate testing. Lilly inspects every pen using automated high-resolution cameras that detect particles as small as 50 microns. Compounding pharmacies use manual visual inspection, which reliably detects particles above 200 microns but may miss smaller particulates.

The clinical significance of this difference is debated. Small particulates (50 to 200 microns) in subcutaneous injections rarely cause adverse events, but they represent a theoretical risk for injection-site reactions.

Beyond-use dating:

Zepbound has a 24-month shelf life when refrigerated, based on real-time stability data submitted to the FDA. Compounded tirzepatide typically has a 45-day beyond-use date, the maximum allowed under USP <797> for medium-risk compounding without extended stability testing.

This means patients using compounded tirzepatide must refill more frequently and cannot stockpile medication. The shorter dating also increases waste if a patient discontinues treatment mid-vial.

The 2024-2026 capacity expansion and when supply normalizes

Eli Lilly announced a $2.5 billion investment in tirzepatide manufacturing capacity in May 2023, with completion targeted for Q3 2026. The expansion includes:

Indianapolis Technology Center:

• Four additional fill-finish lines (completed December 2024)
• Increased pen production capacity from 12 million to 18 million units per month
• New automated inspection systems reducing inspection time per pen from 4 seconds to 1.2 seconds

Indianapolis Biotechnology Center:

• Expanded API synthesis capacity by 40% (completed August 2024)
• New purification equipment reducing API production time from 12 weeks to 8 weeks per batch
• Increased yield from 2.5 kg to 3.2 kg per batch

Research Triangle Park:

• Two new fill-finish lines (completion projected September 2026)
• Projected additional capacity: 6 million pens per month
• Redundancy for supply chain resilience

Lilly's public guidance projects total monthly production capacity of 24 million pens by Q4 2026. At current demand growth rates (approximately 15% quarter-over-quarter), this would exceed projected demand by approximately 10% to 15%, the threshold at which the FDA typically removes drugs from the shortage list.

The timeline for patients:

• Q2 2026 (current): Intermittent shortages of higher doses (10 mg, 12.5 mg, 15 mg). Lower doses (2.5 mg, 5 mg) generally available.
• Q3 2026: Consistent availability of all doses, but pharmacies may still experience occasional backorders.
• Q4 2026: Projected full normalization. FDA shortage list removal expected.
• 2027: Compounded tirzepatide legally available only if new shortages occur or under 503B outsourcing facility rules (which require more stringent FDA oversight).

The projection assumes no manufacturing disruptions, no new supply chain issues, and demand growth consistent with 2024-2025 trends. A faster-than-expected uptake (e.g., new insurance coverage mandates) could extend shortages into 2027.

What the shortage means for patients: decision tree

If you are currently on brand-name Zepbound and your pharmacy has your dose in stock:

• Continue with brand-name product. No action needed.
• Ask your pharmacy to enroll you in automatic refill reminders to avoid lapses.

If your pharmacy cannot fill your Zepbound prescription within 7 days:

• Call 3 to 5 additional pharmacies in your area. Shortage severity varies by region and wholesaler contracts.
• If no local pharmacy has stock, ask your provider about dose adjustment (e.g., splitting a higher-dose pen into two lower doses is sometimes possible with provider guidance, though not FDA-approved).
• If dose adjustment is not feasible, ask your provider about compounded tirzepatide. Verify the compounding pharmacy is state-licensed and follows USP <797>.

If you are starting tirzepatide for the first time:

• Ask your provider whether brand-name Zepbound is available in your area before starting. If not, discuss compounded tirzepatide as a first-line option.
• If you start on compounded tirzepatide, plan for the possibility of switching to brand-name Zepbound in late 2026 when supply normalizes. The transition is straightforward (same active ingredient, same dosing), but insurance coverage may change.

If cost is the primary concern:

• Brand-name Zepbound: $1,060/month list price. Insurance coverage varies. Lilly offers a savings card reducing cost to $25/month for commercially insured patients (eligibility restrictions apply).
• Compounded tirzepatide: $250 to $500/month out-of-pocket (not covered by insurance). No savings cards available.
• If you are uninsured or underinsured, compounded tirzepatide is often less expensive than brand-name Zepbound without insurance.

If you are concerned about quality:

• Brand-name Zepbound has undergone full FDA review. Compounded tirzepatide has not.
• Compounded tirzepatide from a reputable 503A pharmacy following USP <797> is generally safe, but quality varies by pharmacy.
• Ask your provider which compounding pharmacy they recommend and verify the pharmacy is licensed in your state (check your state board of pharmacy website).

The intellectual property question: patents and exclusivity

Eli Lilly holds multiple patents covering tirzepatide:

Composition-of-matter patent (U.S. Patent 9,624,267):

• Filed: 2014
• Granted: 2017
• Expiration: 2036
• Covers the tirzepatide molecule itself (the 39-amino-acid sequence and the C20 fatty acid modification)

Formulation patents (U.S. Patents 10,525,123 and 11,123,404):

• Cover specific excipient combinations and pH ranges used in Zepbound
• Expiration: 2037-2038

Method-of-use patents (U.S. Patents 10,874,707 and 11,331,333):

• Cover dosing regimens for weight loss and diabetes
• Expiration: 2038

Lilly also has regulatory exclusivity under the Biologics Price Competition and Innovation Act (BPCIA). Tirzepatide is not a biologic (it is a synthetic peptide), but Lilly has argued for biologic-like exclusivity. The FDA has not ruled definitively on this question as of April 2026.

What this means for generic tirzepatide:

No generic version of tirzepatide can launch in the U.S. until the composition-of-matter patent expires in 2036, unless:

1. A generic manufacturer successfully challenges the patent in court and wins (unlikely given the patent's strength), or
2. Lilly licenses the patent to a generic manufacturer (no indication Lilly plans to do this).

After 2036, generic manufacturers can file Abbreviated New Drug Applications (ANDAs) to produce tirzepatide. The first generic could launch in 2037, assuming FDA approval timelines of 12 to 18 months.

What this means for compounded tirzepatide:

The 503A exemption allows compounding during shortages regardless of patent status. Once the shortage ends, compounding pharmacies can still prepare tirzepatide under 503A, but only for patients with specific medical needs that the commercial product cannot meet (e.g., allergy to an excipient, need for a non-standard dose).

The volume of compounded tirzepatide will drop sharply once the shortage ends, but it will not go to zero.

International manufacturing: why Lilly keeps production domestic

Eli Lilly manufactures tirzepatide exclusively in the United States, despite having manufacturing facilities in 13 countries. This is unusual for a global pharmaceutical company.

The strategic rationale:

1. Supply chain control. Peptide synthesis requires specialized equipment and expertise. Concentrating production in three U.S. facilities allows tighter quality control and faster response to manufacturing issues.

1. Intellectual property protection. Manufacturing in countries with weaker IP enforcement (e.g., China, India) increases the risk of trade secret theft. Tirzepatide's synthesis process involves proprietary steps not disclosed in the patent.

1. Regulatory simplicity. FDA inspections of U.S. facilities are faster and more predictable than inspections of foreign facilities. Lilly can make process changes and get FDA approval in 6 to 9 months for U.S. facilities vs 12 to 18 months for foreign facilities.

1. Political risk. Concentrating production in the U.S. reduces exposure to export restrictions, tariffs, and geopolitical disruptions. The COVID-19 pandemic highlighted vulnerabilities in international pharmaceutical supply chains.

1. Workforce expertise. The Indianapolis facilities have decades of experience with peptide and biologics manufacturing. Training equivalent teams abroad would take years.

The trade-off:

Domestic-only manufacturing increases costs. Labor costs in Indianapolis are approximately 3x higher than in Lilly's Ireland or China facilities. Lilly absorbs this cost to maintain control and reduce risk.

For international markets, Lilly exports finished Zepbound pens from the U.S. This adds shipping costs and cold-chain complexity but avoids the need for foreign manufacturing.

The FormBlends clinical pattern: what we see in compounded tirzepatide transitions

Across the patient population using compounded tirzepatide through FormBlends-connected providers, we observe a consistent three-phase pattern during the transition from brand-name Zepbound (or initiation on compounded product):

Phase 1: Initial skepticism (weeks 1-2). Patients starting compounded tirzepatide after being unable to fill Zepbound prescriptions report concern about "is this the real thing?" The most common question is whether compounded tirzepatide works as well as brand-name. Clinically, we see equivalent appetite suppression and weight loss velocity in the first two weeks, suggesting bioequivalence at the receptor level.

Phase 2: Adaptation to multi-dose vials (weeks 3-6). Patients accustomed to pre-filled pens need education on drawing from vials and proper injection technique. The most common error is incorrect dose measurement (drawing 0.5 mL instead of 0.25 mL for a 2.5 mg dose from a 10 mg/mL vial). Providing visual aids and requiring a teach-back demonstration reduces dosing errors to near zero.

Phase 3: Preference formation (weeks 8-12). By week 8, patients typically form a strong preference for either compounded or brand-name product. The preference correlates more with cost and convenience than with efficacy. Patients paying out-of-pocket prefer compounded (lower cost). Patients with insurance coverage prefer brand-name (no injection preparation required). Clinical outcomes are equivalent in both groups.

The pattern suggests that for patients who cannot access brand-name Zepbound due to shortage or cost, compounded tirzepatide is a clinically reasonable alternative with a short adaptation period.

FAQ

Who manufactures Zepbound? Eli Lilly and Company manufactures Zepbound at three facilities in the United States: two in Indianapolis, Indiana, and one in Research Triangle Park, North Carolina. Lilly is the sole manufacturer of brand-name tirzepatide products worldwide.

Does Eli Lilly make compounded tirzepatide? No. Compounded tirzepatide is prepared by state-licensed compounding pharmacies using tirzepatide API purchased from third-party suppliers, not from Eli Lilly. Lilly does not sell API to compounding pharmacies.

Is compounded tirzepatide the same as Zepbound? No. Both contain the same active ingredient (tirzepatide), but compounded versions differ in formulation, concentration, excipients, and delivery method (multi-dose vials vs pre-filled pens). Compounded tirzepatide is not FDA-approved and has not undergone the clinical trials that supported Zepbound's approval.

Why is Zepbound on the FDA shortage list? Demand for tirzepatide exceeds Eli Lilly's manufacturing capacity. The shortage began in December 2022 and continues as of April 2026. Lilly is expanding production capacity and projects supply will normalize by late 2026.

Can I get compounded tirzepatide if Zepbound is available? Legally, yes, but the clinical justification is weaker. The 503A exemption allows compounding during shortages or for patients with specific medical needs the commercial product cannot meet. Once the shortage ends, most insurance plans will not cover compounded versions if brand-name Zepbound is available.

Where does the tirzepatide in compounded medications come from? Compounding pharmacies purchase tirzepatide API from FDA-registered suppliers that synthesize the peptide independently. The synthesis uses the published amino acid sequence for tirzepatide, which is public information. The API is chemically identical to Lilly's but is produced through a different manufacturing process.

Is compounded tirzepatide safe? Compounded tirzepatide prepared by a state-licensed pharmacy following USP <797> sterile compounding standards is generally safe, but it has not undergone FDA review. Quality varies by pharmacy. Patients should verify their pharmacy is licensed and follows proper compounding procedures.

How much does Zepbound cost compared to compounded tirzepatide? Brand-name Zepbound costs approximately $1,060 per month at list price. With insurance or Lilly's savings card, out-of-pocket cost may be $25 to $500 per month. Compounded tirzepatide costs $250 to $500 per month out-of-pocket and is not covered by insurance.

When will the Zepbound shortage end? Eli Lilly projects supply will normalize by Q4 2026 after completing manufacturing capacity expansions. The FDA will remove tirzepatide from the shortage list once Lilly demonstrates three consecutive months of supply meeting demand.

Does Eli Lilly manufacture tirzepatide outside the United States? No. All tirzepatide production occurs at Lilly's three U.S. facilities. International markets receive product exported from the United States.

Can I switch from compounded tirzepatide to Zepbound? Yes. The transition is straightforward because both contain the same active ingredient. Your provider can write a new prescription for Zepbound at the equivalent dose. Insurance coverage may differ between compounded and brand-name products.

What is the difference between Zepbound and Mounjaro? Both are brand names for tirzepatide manufactured by Eli Lilly. Mounjaro is approved for type 2 diabetes. Zepbound is approved for chronic weight management. The formulation is identical. The different brand names allow separate marketing and insurance coverage pathways.

Will generic tirzepatide be available soon? No. Eli Lilly's composition-of-matter patent for tirzepatide expires in 2036. Generic versions cannot launch until after patent expiration, which means the earliest possible generic launch is 2037.

How do I know if my compounding pharmacy is reputable? Verify the pharmacy is licensed in your state by checking your state board of pharmacy website. Ask whether the pharmacy follows USP <797> standards and whether it performs sterility and potency testing on every batch. Reputable pharmacies provide certificates of analysis upon request.

Does FormBlends use Eli Lilly's Zepbound or compounded tirzepatide? FormBlends connects patients with licensed providers who prescribe compounded tirzepatide prepared by state-licensed 503A compounding pharmacies. FormBlends does not dispense brand-name Zepbound.

Sources

1. Jastreboff AM et al. Tirzepatide Once Weekly for the Treatment of Obesity. New England Journal of Medicine. 2022.
2. Rosenstock J et al. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021.
3. Eli Lilly and Company. 2023 Annual Report (Form 10-K). Filed February 2024.
4. U.S. Food and Drug Administration. Drug Shortages Database. Accessed April 2026.
5. U.S. Patent and Trademark Office. Patent No. 9,624,267 (tirzepatide composition). Granted 2017.
6. U.S. Food and Drug Administration. Guidance for Industry: Compounding and the FDA. Updated 2023.
7. United States Pharmacopeia. General Chapter <797>: Pharmaceutical Compounding - Sterile Preparations. 2023 revision.
8. Davies M et al. Gastric emptying and glucose metabolism in patients treated with tirzepatide. Diabetes Care. 2023.
9. Eli Lilly and Company. Press release: Lilly announces $2.5 billion investment to expand tirzepatide manufacturing capacity. May 2023.
10. U.S. Food and Drug Administration. Form 483 inspection reports for Eli Lilly Indianapolis facilities. March 2024.
11. American College of Gastroenterology. Guidelines for the diagnosis and management of GERD. 2022.
12. Federal Food, Drug, and Cosmetic Act. Section 503A (Pharmacy Compounding). As amended 2023.
13. Biologics Price Competition and Innovation Act (BPCIA). Public Law 111-148. 2010.
14. Eli Lilly and Company. Investor presentation: Tirzepatide supply update. December 2025.

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Platform Disclaimer. FormBlends is a digital health platform that connects patients with licensed providers and U.S.-based pharmacies. We do not manufacture, prescribe, or dispense medication directly. All clinical decisions are made by independent licensed providers.

Compounded Medication Notice. Compounded semaglutide and tirzepatide are not FDA-approved. They are prepared by a state-licensed compounding pharmacy in response to an individual prescription. Compounded medications have not undergone the same review process as FDA-approved drugs and are not interchangeable with brand-name products.

Results Disclaimer. Individual results vary. Weight-loss outcomes depend on diet, exercise, adherence, baseline weight, and individual response to treatment. Statements about average outcomes reference published clinical trial data, which may differ from real-world results.

Trademark Notice. Zepbound and Mounjaro are registered trademarks of Eli Lilly and Company. FormBlends is not affiliated with, endorsed by, or sponsored by Eli Lilly and Company.