Suppliers and packagers for gimoti

gimoti

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Qol Medcl	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

Suppliers and packagers for gimoti

Last updated: May 27, 2026

Gimoti Drug Suppliers (Gimoti-Ready Manufacturers and Upstream Sources): Who Makes It and Who Supplies Key Inputs?

Executive summary: Gimoti (metoclopramide) is marketed in the US as an FDA-regulated product, but “suppliers” is not a single-source fact. The upstream supplier landscape depends on whether the ask is (1) finished-dose manufacturers, (2) active pharmaceutical ingredient (API) manufacturers, or (3) excipient and packaging suppliers. With no product-specific contract-manufacturing/API sourcing details provided here, a complete, accurate supplier list cannot be produced.

If the intent is to identify finished-dose manufacturers and any contract manufacturing/labeler relationships, the correct source is the FDA “Orange Book” listing for Gimoti and associated FDA product and label information. Without those Orange Book and labeling inputs in the prompt, producing a complete supplier roster risks factual error.

What manufacturers supply finished Gimoti (metoclopramide) for distribution in the US?

Featured snippet answer: Use the FDA Orange Book listing and the FDA drug label “manufactured for / distributed by” statements to identify the finished-dose drug labeler and manufacturing site(s). Those are the only supplier identifiers that are consistently auditable for US-market Gimoti.

How to read Gimoti’s label for the correct “supplier”

• “Manufactured for” or “Distributed by” identifies the marketing authorization holder and labeler.
• “Manufactured by” identifies the finished-dose contract manufacturer (if different).
• Packaging text identifies the packager when listed.

Where to verify finished-dose supplier facts

• FDA Orange Book product listing for metoclopramide nasal spray marketed as Gimoti.
• FDA drug label (container label and prescribing information) associated with the NDA/BLA product.

Which companies supply Gimoti’s active pharmaceutical ingredient (metoclopramide HCl)?

Featured snippet answer: API suppliers are confirmed via the Orange Book “Applicant” and the listing of manufacturers tied to the approved product, plus any disclosures in FDA label sections that identify the API or manufacturer.

API vs. finished-dose supplier: what changes in the supply map

• API suppliers can differ from the finished-dose manufacturer.
• Contract manufacturers often buy API from separate global producers.
• Multiple approved strengths and dosage forms can have different manufacturing networks.

Why a precise API supplier list needs Orange Book and label sourcing data

• Orange Book lists “applicant” and sometimes the manufacturing/labeler entities for the approved product.
• API manufacturer names are not always printed in the label.
• Without the Orange Book listing text and label “manufactured by” fields, listing specific API suppliers is not auditable.

What excipient and packaging suppliers support Gimoti nasal spray production?

Featured snippet answer: Excipients and packaging components are not reliably enumerated in the public label. Confirmed suppliers usually appear only in technical packages, DMFs, or internal procurement data. Public disclosures are limited to general excipient names, not supplier-company identities.

Nasal spray supply chain components that matter

• Formulation: nasal spray excipients and solution components (as named in the prescribing information).
• Device: nasal delivery hardware and any prefilled components.
• Primary packaging: container, closure, and any spray actuator subcomponents.

Public-source limits

• Prescribing information typically names excipients but not specific vendor companies.
• Supplier identity often requires DMF-linked vendor disclosures or procurement records.

How many suppliers cover Gimoti, and is it single-source or multi-source?

Featured snippet answer: Public information supports “how many labelers/manufacturers appear on FDA-listed product records,” not how many raw-material vendors exist.

Finished-dose manufacturing network: what drives count

• Changes in contract manufacturing sites.
• Labeler updates over time.
• Site changes via CMC supplements.

API and excipients: what drives count

• Global API sourcing strategies.
• Qualification of secondary suppliers.
• Lead-time risk management and cold-changeover in spray systems.

What is the Orange Book status of Gimoti and what does it imply for supplier identification?

Featured snippet answer: Orange Book status determines which NDA product record is relevant and what entity names appear in FDA’s approved-product listing. Supplier identification depends on the specific Orange Book record fields.

What to extract from Orange Book for supplier mapping

• Applicant/holder name.
• Dosage form and route.
• Strength(s).
• Listing status.
• Patent and exclusivity linkage (useful for litigation risk, not directly for vendor identity).

Which generic or biosimilar competitors impact Gimoti’s supplier bargaining power?

Featured snippet answer: Competitor entry risk can change procurement terms and reduce supplier leverage, but it requires a competitor patent/exclusivity timeline and Paragraph IV/ANDA or 505(b)(2) details to quantify.

Supply-chain effects that typically follow entry

• More qualified alternative sources.
• Shorter bid cycles after competition.
• Requalification of manufacturing changes to reduce cost.

What patent estate details for Gimoti affect manufacturing partners and tech-transfer?

Featured snippet answer: Patent estate controls process and formulation tech-transfer rights, which in turn affects which manufacturers can produce a compliant copycat or authorized generic.

Typical IP categories that influence suppliers

• Formulation and stability of metoclopramide nasal spray.
• Delivery system/device assembly and integration.
• Method-of-use (indication) and dosing regimens.

What patent litigation or settlements involve Gimoti and can reveal supply partners?

Featured snippet answer: Litigation can reveal entities involved in development and manufacturing through pleadings. But litigation facts are not provided in the prompt, and Gimoti-specific case data must be cited from reliable legal dockets.

Commercial exposure: does Gimoti’s volume concentration make suppliers more or less interchangeable?

Featured snippet answer: High volume or sole-site manufacturing increases supply continuity risk and raises the cost of switching suppliers. Volume concentration requires sales data, which is not provided here.

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Key Takeaways

• “Suppliers for Gimoti” splits into three different supply-chain questions: finished-dose manufacturers, API manufacturers, and excipient/packaging vendors.
• Public, auditable supplier identification for finished-dose products requires Gimoti’s FDA Orange Book record and label “manufactured for / manufactured by” fields.
• API and excipient/packaging vendor companies are often not publicly identified in FDA labeling; those identities typically require Orange Book-linked manufacturing statements, DMF-linked references, or nonpublic procurement data.
• Without the specific Orange Book listing text and label entity fields for Gimoti, a complete supplier list cannot be produced accurately.

FAQs

1. How do I find Gimoti’s finished-dose manufacturer from FDA labeling?
2. Does Gimoti have multiple approved manufacturing sites in the Orange Book?
3. Where are API manufacturers for metoclopramide nasal spray typically disclosed in public sources?
4. Do Orange Book exclusivity terms affect which contract manufacturers can participate in production?
5. What public sources can confirm packaging actuator suppliers for nasal spray products?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-05-27).
2. FDA. Drugs@FDA: Gimoti (metoclopramide) prescribing information and product label. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-05-27).