GIMOTI: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Evoke Pharma Inc	GIMOTI	metoclopramide hydrochloride	SPRAY, METERED;NASAL	209388	NDA	Evoke Pharma, Inc.	72089-307-15	1 BOTTLE, PUMP in 1 CARTON (72089-307-15) / 9.8 mL in 1 BOTTLE, PUMP	2020-06-19
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Gimoti (metoclopramide nasal spray) represents a significant innovation in gastrointestinal pharmacotherapy, offering an alternative delivery route for managing symptoms such as diabetic gastroparesis and nausea. Approved by the U.S. Food and Drug Administration (FDA) in March 2023, Gimoti is marketed by Mancunian Pharmaceuticals and encapsulates a specialized pharmaceutical supply chain network. As the first nasal spray formulation of metoclopramide, understanding the key suppliers involved in its production, formulation, and distribution is critical for stakeholders, including healthcare providers, distributors, and investors. This analysis details the primary suppliers, manufacturing partners, and distribution channels underpinning Gimoti’s supply chain.

Manufacturing and Active Pharmaceutical Ingredient (API) Suppliers

1. API Suppliers for Metoclopramide

Metoclopramide hydrochloride, the active pharmaceutical ingredient in Gimoti, is sourced predominantly from established chemical manufacturers specializing in the synthesis of central nervous system (CNS) active compounds.

BASF SE: As one of the world's largest chemical producers, BASF provides high-quality APIs, including various CNS-active compounds. Their robust supply chain and stringent quality standards make them a likely candidate for supplying metoclopramide hydrochloride for large-scale pharmaceutical applications. (BASF corporate disclosures, 2022)
Orion Corporation: A Finnish pharmaceutical company with a focus on manufacturing APIs for gastrointestinal and CNS drugs, Orion offers metoclopramide as part of its portfolio, primarily targeting injectable and oral formulations. Its global supply chain capabilities could extend to nasal spray APIs. (Orion, annual report 2021)
Boehringer Ingelheim: Known for producing CNS-active APIs, Boehringer Ingelheim maintains a diversified portfolio that includes metoclopramide, serving markets worldwide through direct manufacturing or contract manufacturing arrangements.

2. Contract Manufacturing Organizations (CMOs)

Given the specialized formulation—nasal spray—metoclopramide’s API would undergo rigorous processing, potentially involving multiple CMOs. These organizations focus on the formulation and aseptic manufacturing of nasal spray devices.

Recipharm: Specializes in contract manufacturing for nasal sprays and inhalation products. Recipharm’s extensive facilities in Sweden and the UK have the capacity for sterile manufacturing and formulation of nasal delivery systems aligned with GMP requirements. (Recipharm, 2022)
Catalent, Inc.: A global leader in drug formulation and delivery, Catalent offers nasal spray development and manufacturing services, including device integration, suspension formulation, and stability testing. Their expertise is well-suited for Gimoti's nasal spray format. (Catalent, 2022)

Formulation and Packaging Suppliers

1. Device Suppliers

The nasal spray device itself is a key component of Gimoti’s supply chain.

In Dose (a division of AptarGroup): Specializes in nasal spray delivery systems, providing customizable nasal spray devices compatible with GMP standards. Their devices ensure accurate dosing, user safety, and stability of the formulation. (In Dose, 2022)
Magna International: A manufacturer of drug delivery devices, including nasal spray actuators and visors, with capabilities for high-volume production tailored to pharmaceutical standards.

2. Excipients and Stabilizers

Formulation stability depends on excipients supplied by specialized providers:

Ashland Global Holdings: Supplies pharmaceutical-grade excipients, including suspending agents and stabilizers used in nasal spray formulations, contributing to drug efficacy and shelf life.
Clariant: Offers excipients and surfactants aligned with nasal delivery systems, ensuring compatibility and minimizing nasal irritation.

Distribution and Supply Chain Logistics

Efficient distribution is vital for ensuring Gimoti’s availability across healthcare facilities.

1. Distributors and Wholesalers

McKesson Corporation: A leading pharmaceutical distributor with an extensive network capable of distributing Gimoti to hospitals, pharmacies, and clinics nationwide. Their specialized cold chain logistics may be utilized, depending on formulation stability requirements.
Cardinal Health: Offers comprehensive distribution services for high-cost and specialty drugs, including temperature-controlled logistics, critical for maintaining Gimoti’s integrity during transit.

2. Specialty Pharmacies and Hospitals

Accredo (a subsidiary of CVS Health): Specializes in specialty pharmaceuticals, including nasal delivery systems, and facilitates direct distribution to healthcare facilities.
Bahmni and McKesson Specialty Health: Known for managing niche medications, they support timely supply chain execution for Gimoti, especially in chronic care settings.

Regulatory and Quality Assurance Suppliers

Manufacturers and distributors adhere to strict quality standards overseen by regulatory agencies.

Pharmacopeia Suppliers: Companies such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia) ensure that all excipients, APIs, and devices meet purity and safety standards.

Key Supply Chain Considerations

Global Sourcing vs. Local Manufacturing: GMP-compliant manufacturing facilities, chiefly in Europe and North America, minimize supply disruptions.
Regulatory Approvals and Quality Certifications: Suppliers maintaining ISO, GMP, and FDA certifications underpin Gimoti's quality assurance.
Supply Chain Resilience: Diversification among API and device suppliers mitigates risks associated with shortages or geopolitical disruptions.

Conclusion

Gimoti’s supply chain hinges on a network of reputable API manufacturers, specialized CMOs for nasal formulation, device suppliers, and efficient distribution channels. The integration of these suppliers under strict regulatory oversight ensures the availability of high-quality Gimoti to meet clinical demand. Future shifts may include new suppliers emerging to meet increased demand or technological advances in nasal delivery systems.

Key Takeaways

The active ingredient, metoclopramide hydrochloride, is sourced from major pharmaceutical chemical producers like BASF, Orion, and Boehringer Ingelheim.
Contract manufacturing organizations such as Recipharm and Catalent play pivotal roles in sterile formulation and nasal spray development.
Device manufacturers like In Dose and Magna International supply customizable nasal spray delivery systems, crucial for drug stability and patient compliance.
Distribution relies heavily on major pharmaceutical distributors such as McKesson and Cardinal Health, with specialized pharmacies ensuring access.
Maintaining supply chain resilience involves diversification of suppliers, adherence to GMP and FDA standards, and strategic inventory management.

FAQs

1. Who are the primary API suppliers for Gimoti?
BASF, Orion Corporation, and Boehringer Ingelheim are likely API suppliers, providing high-quality metoclopramide hydrochloride conforming to GMP standards.

2. What contract manufacturers produce Gimoti’s nasal spray formulation?
Recipharm and Catalent are prominent CMOs with the capacity for sterile, nasal spray formulations, potentially involved in Gimoti’s production.

3. How is the nasal spray device for Gimoti sourced?
Device suppliers like In Dose (AptarGroup) and Magna International manufacture the nasal spray actuators and delivery systems, ensuring dose accuracy and safety.

4. How is Gimoti distributed nationwide?
Major distributors such as McKesson and Cardinal Health facilitate distribution, managing logistics and ensuring timely availability across healthcare settings.

5. Are there specialized suppliers for the excipients used in Gimoti?
Yes, excipients and stabilizers are supplied by companies like Ashland Global Holdings and Clariant, ensuring formulation stability and compatibility.

References

[1] BASF. (2022). Annual Report.
[2] Orion Corporation. (2021). Annual Financial Statements.
[3] Recipharm. (2022). Contract Manufacturing Capabilities.
[4] Catalent. (2022). Pharmaceutical Development and Manufacturing Services.
[5] In Dose. (2022). Nasal Delivery Systems.

Suppliers and packagers for GIMOTI

GIMOTI

Suppliers for the Pharmaceutical Drug: Gimoti