Suppliers and packagers for GADAVIST

GADAVIST

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-325-18	2 CARTON in 1 BOX (50419-325-18) / 5 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS	2011-03-14
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-325-19	10 BOTTLE, GLASS in 1 BOX (50419-325-19) / 65 mL in 1 BOTTLE, GLASS	2011-03-14
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-325-73	30 mL in 1 BOTTLE, GLASS (50419-325-73)	2011-03-14
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-325-74	65 mL in 1 BOTTLE, GLASS (50419-325-74)	2011-03-14
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-325-11	2 CARTON in 1 BOX (50419-325-11) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE	2011-03-14
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-325-12	2 CARTON in 1 BOX (50419-325-12) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE	2011-03-14

Gadavist Drug Supply Chain Analysis

Last updated: February 19, 2026

This report identifies key suppliers and manufacturers involved in the Gadavist drug supply chain. Gadavist, a gadolinium-based contrast agent used in magnetic resonance imaging (MRI), relies on a complex network of raw material providers, active pharmaceutical ingredient (API) manufacturers, and finished dosage form producers. Analysis focuses on upstream and downstream dependencies and potential points of supply risk.

Who Manufactures Gadavist?

Gadavist is manufactured by Bayer AG. Bayer is a vertically integrated pharmaceutical company that manages the production of its contrast agents from raw material sourcing to final product distribution.

What is the Active Pharmaceutical Ingredient in Gadavist?

The active pharmaceutical ingredient (API) in Gadavist is gadobutrol. Gadobutrol is a macrocyclic gadolinium complex.

What are the Key Raw Materials for Gadobutrol Synthesis?

The synthesis of gadobutrol requires several critical raw materials. These include:

• Gadolinium Salts: Primarily gadolinium chloride or gadolinium oxide, serving as the source of the paramagnetic gadolinium ion.
• Organic Ligands: Specifically, 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA) or its derivatives, which chelate the gadolinium ion to form the stable complex.
• Solvents: Various organic solvents are used in the synthesis and purification steps.
• Reagents: Specific chemicals are required for the chemical reactions involved in forming the gadobutrol molecule.

Who Supplies Gadolinium Salts?

The global supply of rare earth elements, including gadolinium, is concentrated in a few countries. Major producers and suppliers of gadolinium salts include:

• China: Dominates global rare earth production and processing.
• Australia: Has significant rare earth deposits.
• United States: Resources exist, but production levels vary.
• Myanmar: Another significant source of rare earth materials.

Companies involved in the processing and supply of purified gadolinium compounds for pharmaceutical use are specialized chemical manufacturers. Identifying direct suppliers of pharmaceutical-grade gadolinium salts to Bayer can be challenging due to proprietary supplier agreements. However, companies operating in the rare earth chemical processing sector are potential upstream providers. These may include:

• Lynas Rare Earths: An Australian company with significant mining and processing operations.
• MP Materials Corp.: Operates the Mountain Pass mine in California.
• Various Chinese rare earth chemical companies: Such as Northern Rare Earth Group and China Rare Earth Group, which are vertically integrated producers.

What are the Manufacturing Processes for Gadobutrol?

The synthesis of gadobutrol involves the chelation of a gadolinium salt with a specific organic ligand (DOTA derivative). This process typically includes:

1. Ligand Synthesis: Production of the macrocyclic ligand molecule.
2. Complexation: Reaction of the ligand with a soluble gadolinium salt under controlled conditions to form the gadobutrol complex.
3. Purification: Removal of unreacted materials, byproducts, and impurities through techniques such as chromatography and crystallization.
4. Quality Control: Rigorous analytical testing to ensure purity, potency, and compliance with pharmaceutical specifications.

Bayer AG's internal manufacturing facilities are presumed to handle the bulk of gadobutrol API production. However, contract manufacturing organizations (CMOs) specializing in complex API synthesis for pharmaceutical clients could potentially be involved in specific stages or backup supply.

Are There Contract Manufacturing Organizations (CMOs) Involved in Gadobutrol Production?

While Bayer is known to have significant in-house API manufacturing capabilities, the pharmaceutical industry often utilizes CMOs for specific steps or to enhance supply chain resilience. Identifying specific CMOs contracted for gadobutrol API synthesis is difficult due to confidentiality agreements. However, CMOs with expertise in metal chelation chemistry and high-purity API manufacturing would be candidates. Examples of such CMOs include:

• Lonza Group: A Swiss multinational chemical and biotechnology company.
• Catalent, Inc.: A global provider of drug delivery technologies and development services.
• Patheon (part of Thermo Fisher Scientific): Offers pharmaceutical contract development and manufacturing services.

How is Gadavist Formulated and Packaged?

Once the gadobutrol API is produced, it is formulated into the final Gadavist drug product. This involves:

1. Formulation: Dissolving gadobutrol API in sterile water for injection.
2. Addition of Excipients: Inclusion of specific excipients, if any, to ensure stability and isotonicity.
3. Sterile Filtration: Removal of particulate matter and microorganisms.
4. Aseptic Filling: Filling the sterile solution into vials or pre-filled syringes under aseptic conditions.
5. Packaging: Labeling and packaging the final product for distribution.

Bayer's own pharmaceutical manufacturing sites are the primary locations for Gadavist formulation and packaging. These facilities adhere to strict Good Manufacturing Practices (GMP) to ensure product safety and quality.

What is the Distribution Network for Gadavist?

Gadavist is distributed globally through Bayer's established pharmaceutical distribution channels. This network typically involves:

• Wholesalers and Distributors: Companies that purchase large quantities of Gadavist from Bayer and supply it to healthcare facilities.
• Hospitals and Clinics: Direct procurement or through intermediaries.
• Radiology Centers: Specialized facilities requiring contrast agents.

Key distributors in major markets would include large pharmaceutical wholesalers. For instance:

• In the United States: McKesson Corporation, Cardinal Health, Inc., and AmerisourceBergen Corporation.
• In Europe: Companies like Phoenix Group and Celesio AG.

The cold chain management and secure transport of injectable pharmaceutical products are critical aspects of this distribution.

What are the Regulatory Considerations for Gadavist Supply?

The supply chain for Gadavist is subject to stringent regulatory oversight by health authorities worldwide. Key regulatory bodies include:

• U.S. Food and Drug Administration (FDA): Oversees drug manufacturing, quality, and distribution in the United States.
• European Medicines Agency (EMA): Regulates pharmaceuticals within the European Union.
• Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
• Other national regulatory agencies.

These agencies mandate adherence to GMP for all manufacturing sites involved in API and finished product production. They also require rigorous documentation of the supply chain, including supplier qualifications and raw material traceability. Changes in manufacturing processes, suppliers, or facilities require regulatory notification or approval.

What are Potential Supply Chain Risks for Gadavist?

The Gadavist supply chain faces several potential risks:

• Raw Material Dependency: Reliance on a limited number of regions for rare earth elements like gadolinium creates geopolitical and supply disruption risks.
• API Manufacturing Concentration: If Bayer relies heavily on a single manufacturing site or a small number of CMOs for gadobutrol API, any disruption at these sites could impact supply.
• Quality Control Failures: Issues in raw material quality or manufacturing processes can lead to batch rejections and shortages.
• Geopolitical Instability: Trade disputes or political instability in regions supplying critical raw materials can affect availability.
• Logistical Challenges: Global transportation disruptions, natural disasters, or pandemics can impede the movement of raw materials and finished products.
• Regulatory Scrutiny: Increased regulatory inspection or enforcement actions at manufacturing sites can lead to production halts.
• Patent Expirations: While Gadavist is a branded product, the expiration of patents related to its synthesis or formulation could lead to generic competition and increased supply chain complexity through new manufacturers. Bayer holds numerous patents covering Gadavist. For example, U.S. Patent No. 7,388,004, titled "Gadolinium-containing complex and pharmaceutical preparation thereof," covers aspects of gadobutrol and its use.
• Environmental Regulations: Stricter environmental regulations on rare earth mining and processing can impact raw material availability and cost.

Key Takeaways

Bayer AG controls the Gadavist supply chain, from API synthesis to finished product manufacturing and distribution. Key upstream dependencies include suppliers of gadolinium salts, with China being a dominant source. The synthesis of the active pharmaceutical ingredient, gadobutrol, is a complex chemical process likely conducted in-house by Bayer, though CMOs with specialized capabilities could be involved. The global distribution network is managed by Bayer and involves major pharmaceutical wholesalers. Potential supply chain vulnerabilities include reliance on geographically concentrated raw material sources, manufacturing site disruptions, and evolving regulatory landscapes.

Frequently Asked Questions

1. Who are the primary manufacturers of gadolinium salts used in pharmaceutical contrast agents?

The primary manufacturers of gadolinium salts are companies involved in rare earth element mining and chemical processing. These are often located in China, Australia, and the United States. Specific pharmaceutical-grade suppliers operate within these broader industries.

2. What is the expected shelf life of Gadavist?

The shelf life of Gadavist is typically specified on the product packaging and in its prescribing information. It is generally stable when stored at controlled room temperature, protected from light, and does not require refrigeration. For instance, Gadavist vials often have an expiration date of 24 to 36 months from the date of manufacture.

3. How does Bayer ensure the quality of raw materials for Gadavist?

Bayer implements rigorous supplier qualification programs and raw material testing protocols. This includes auditing manufacturing sites of key suppliers, requiring detailed certificates of analysis (CoAs) for each batch of raw material, and conducting internal laboratory testing to verify compliance with established specifications.

4. What are the implications of geopolitical tensions on the Gadavist supply chain?

Geopolitical tensions can lead to trade restrictions, increased tariffs, or disruptions in the export of critical raw materials like gadolinium from producing countries. This can affect the cost and availability of these materials, potentially impacting Gadavist production and pricing.

5. Does Bayer use contract manufacturing organizations (CMOs) for Gadavist API?

While Bayer possesses significant in-house manufacturing capabilities, it is common industry practice to utilize CMOs for specific API synthesis steps or to supplement production capacity. Specific details regarding Bayer's use of CMOs for gadobutrol API are proprietary.

Citations

[1] Bayer AG. (n.d.). Gadavist Prescribing Information. Retrieved from [Bayer's official website or FDA/EMA databases] [2] U.S. Patent No. 7,388,004. (2008). Gadolinium-containing complex and pharmaceutical preparation thereof. [3] Lynas Rare Earths. (n.d.). Products. Retrieved from [Lynas Rare Earths official website] [4] MP Materials Corp. (n.d.). Operations. Retrieved from [MP Materials official website] [5] Lonza Group. (n.d.). API Manufacturing. Retrieved from [Lonza Group official website] [6] Catalent, Inc. (n.d.). API Development & Manufacturing. Retrieved from [Catalent official website] [7] Thermo Fisher Scientific. (n.d.). Patheon Pharmaceutical Services. Retrieved from [Thermo Fisher Scientific official website]