Suppliers and packagers for MONISTAT 3 COMBINATION PACK

MONISTAT 3 COMBINATION PACK

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Medtech Products	MONISTAT 3 COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	020670	NDA	WALGREEN COMPANY	0363-5203-01	1 KIT in 1 PACKAGE, COMBINATION (0363-5203-01) * 1 APPLICATOR in 1 PACKAGE / 1 SUPPOSITORY in 1 APPLICATOR * 9 g in 1 TUBE	2016-04-18
Medtech Products	MONISTAT 3 COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	020670	NDA	CVS PHARMACY, INC	51316-005-01	1 KIT in 1 PACKAGE, COMBINATION (51316-005-01) * 9 g in 1 TUBE (51316-091-01) * 1 SUPPOSITORY in 1 POUCH (51316-090-01)	2022-01-30
Medtech Products	MONISTAT 3 COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	020670	NDA	Insight Pharmaceuticals LLC	63736-017-03	1 KIT in 1 PACKAGE, COMBINATION (63736-017-03) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE	1996-04-16

MONISTAT 3 COMBINATION PACK Supplier Landscape Analysis

Last updated: February 19, 2026

This analysis identifies key suppliers involved in the manufacturing and distribution of MONISTAT 3 COMBINATION PACK, a leading over-the-counter treatment for vaginal yeast infections. The data focuses on active pharmaceutical ingredient (API) sourcing, finished product manufacturing, and the primary marketing authorization holder.

Who Holds the Primary Marketing Authorization for MONISTAT 3 COMBINATION PACK?

Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, is the holder of the New Drug Application (NDA) and the primary marketing authorization for MONISTAT 3 COMBINATION PACK in the United States. This authorization dictates the product's regulatory compliance and market access.

What Are the Active Pharmaceutical Ingredients (APIs) in MONISTAT 3 COMBINATION PACK?

MONISTAT 3 COMBINATION PACK is a combination product containing three active ingredients:

• Miconazole Nitrate: An antifungal agent used to treat vaginal yeast infections.
• Hydroxypropyl Methylcellulose: A cellulose derivative used as a pharmaceutical excipient, primarily as a binder and film-coating agent in tablets and as a thickening agent in topical formulations.
• White Petrolatum: A semi-solid mixture of hydrocarbons used as a skin protectant and emollient in topical preparations.

The specific CAS numbers for the APIs are as follows:

• Miconazole Nitrate: 24169-02-5
• Hydroxypropyl Methylcellulose: 9004-65-3
• White Petrolatum: 8027-21-4

Who Supplies Miconazole Nitrate for Pharmaceutical Use?

The supply chain for pharmaceutical-grade Miconazole Nitrate is global and involves specialized API manufacturers. Key suppliers identified through patent filings, regulatory submissions, and industry directories include:

• BASF SE: A major global chemical company with a significant pharmaceutical ingredients division.
• Aarti Industries Limited: An Indian multinational company specializing in chemicals and pharmaceuticals, including APIs.
• Shandong Xinhua Pharmaceutical Co., Ltd.: A Chinese pharmaceutical company with a broad portfolio of APIs.
• Anqiu Xinrun Pharmaceutical Co., Ltd.: Another Chinese manufacturer of pharmaceutical ingredients.
• Divi's Laboratories Limited: An Indian API manufacturer with a strong presence in antifungal agents.

These suppliers typically operate under Good Manufacturing Practices (GMP) and must meet stringent quality and regulatory standards to supply the pharmaceutical industry.

Who Supplies Hydroxypropyl Methylcellulose (HPMC) for Pharmaceutical Use?

Hydroxypropyl Methylcellulose is a widely used excipient, with several large-scale manufacturers supplying pharmaceutical grades. Key suppliers include:

• Dow Chemical Company (now DuPont de Nemours, Inc.): Through its historical cellulose ether business, DuPont is a significant producer of HPMC under various trade names like DOWSIL™.
• Shin-Etsu Chemical Co., Ltd.: A Japanese chemical company that produces a range of cellulose ethers, including HPMC, for pharmaceutical applications.
• Ashland Inc.: A global specialty chemicals company that offers pharmaceutical excipients, including HPMC.
• Colorcon, Inc.: While primarily known for tablet coatings, Colorcon utilizes and supplies various excipients, including HPMC, as part of their formulation solutions.

The viscosity and substitution profile of HPMC are critical parameters for pharmaceutical formulation, and suppliers offer a range of grades to meet specific product requirements.

Who Supplies White Petrolatum for Pharmaceutical Use?

White Petrolatum is a refined petroleum product used in many topical pharmaceutical formulations. Major suppliers include:

• ExxonMobil Corporation: A leading global producer of petroleum products, including high-purity petrolatum grades for pharmaceutical and cosmetic use.
• Royal Dutch Shell plc: Another major integrated energy company that supplies petroleum-derived ingredients for various industries, including pharmaceuticals.
• Petroplex, Inc.: A US-based supplier specializing in petrolatum and other petroleum jelly products for industrial and pharmaceutical applications.
• Fiske Brothers Refining Company: A long-standing manufacturer of lubricants and petroleum specialties, including pharmaceutical-grade petrolatum.

Pharmaceutical-grade white petrolatum must meet strict purity standards, such as those defined by the United States Pharmacopeia (USP) or European Pharmacopoeia (EP).

Who Manufactures the Finished MONISTAT 3 COMBINATION PACK Product?

The finished drug product, MONISTAT 3 COMBINATION PACK, is manufactured under contract by companies specializing in pharmaceutical contract manufacturing organizations (CMOs) or by the marketing authorization holder's own manufacturing facilities. While specific CMOs are often proprietary information tied to contractual agreements, companies within Janssen's global network or approved third-party manufacturers would be involved.

Companies like Catalent Pharma Solutions and Thermo Fisher Scientific (Patheon) are examples of large CMOs that have the capabilities to manufacture combination drug products, including vaginal suppositories and topical creams, under strict GMP conditions. Janssen Pharmaceuticals, as part of Johnson & Johnson, also possesses significant internal manufacturing capacity.

What Is the Regulatory Framework Governing API and Finished Product Sourcing?

The sourcing of APIs and the manufacturing of finished drug products are governed by stringent regulatory frameworks to ensure product safety, efficacy, and quality. Key regulations include:

• Current Good Manufacturing Practices (cGMP): Mandated by regulatory bodies such as the U.S. Food and Drug Administration (FDA) [1] and the European Medicines Agency (EMA). cGMP guidelines cover all aspects of production, from raw material sourcing and facility operations to quality control and product release.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. A DMF contains confidential detailed information about the manufacturing, processing, packaging, and storing of the API. The marketing authorization holder references the DMF in their drug application, allowing regulators to review the API manufacturing process without disclosing proprietary information to the drug product applicant.
• ICH Guidelines: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) develops harmonized guidelines for pharmaceutical development and registration. Relevant guidelines include ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) and ICH Q10 (Pharmaceutical Quality System) [2].
• Supply Chain Security and Traceability: Regulations are increasingly focused on ensuring the integrity and traceability of the pharmaceutical supply chain to prevent counterfeiting and ensure product authenticity.

What Are the Key Considerations for Sourcing APIs for MONISTAT 3 COMBINATION PACK?

For a product like MONISTAT 3 COMBINATION PACK, several factors are critical when sourcing APIs:

• Quality and Purity: APIs must meet pharmacopoeial standards (e.g., USP, EP) and the specific requirements outlined in the drug product's marketing authorization. Lot-to-lot consistency is essential.
• Regulatory Compliance: Suppliers must demonstrate adherence to GMP regulations, and their manufacturing facilities are subject to inspection by regulatory authorities.
• Supply Chain Reliability: Ensuring a stable and uninterrupted supply of APIs is paramount to prevent stock-outs and maintain market availability. This involves evaluating supplier capacity, lead times, and geopolitical stability of manufacturing locations.
• Cost-Effectiveness: While quality and reliability are primary, the cost of APIs significantly impacts the overall production cost of the finished product.
• Supplier Audit and Qualification: The marketing authorization holder (Janssen) or its contract manufacturers will conduct rigorous audits of potential API suppliers to verify their quality systems and manufacturing capabilities.
• Intellectual Property: While MONISTAT 3 COMBINATION PACK itself is an established product, the manufacturing processes for the APIs may involve proprietary technology or patents.

What Are the Key Considerations for Sourcing Pharmaceutical Excipients?

For excipients like Hydroxypropyl Methylcellulose and White Petrolatum, the considerations are similar to APIs but may have slightly different emphases:

• Functional Performance: The specific grade of excipient must deliver the desired functionality within the dosage form. For HPMC, this includes viscosity, gelation temperature, and substitution patterns. For White Petrolatum, it's purity and consistency.
• Regulatory Acceptance: Excipients must be approved for pharmaceutical use and comply with relevant pharmacopoeias.
• Traceability and Documentation: Suppliers must provide detailed Certificates of Analysis (CoAs) and maintain robust documentation for traceability.
• Supplier Capacity and Global Reach: For widely used excipients, ensuring sufficient supply volume and reliable delivery from the supplier is crucial.

What Is the Role of Johnson & Johnson in the MONISTAT 3 COMBINATION PACK Supply Chain?

Johnson & Johnson, through its Janssen Pharmaceuticals division, holds the ultimate responsibility for the quality, safety, and efficacy of MONISTAT 3 COMBINATION PACK. This includes:

• Regulatory Oversight: Securing and maintaining the marketing authorization.
• Product Development and Formulation: Defining the product specifications and quality attributes.
• Supply Chain Management: Selecting and managing API and excipient suppliers, as well as contract manufacturers.
• Quality Assurance and Control: Implementing robust quality systems throughout the supply chain.
• Pharmacovigilance: Monitoring the safety of the product post-market.

Johnson & Johnson’s global operations and extensive supply chain network provide a robust foundation for managing the complex requirements of pharmaceutical manufacturing and distribution.

What Are the Potential Risks in the MONISTAT 3 COMBINATION PACK Supply Chain?

Several risks can impact the supply chain for MONISTAT 3 COMBINATION PACK:

• API Shortages: Disruptions at key API manufacturing sites due to quality issues, regulatory actions, or geopolitical events can lead to shortages.
• Excipient Supply Disruptions: Dependence on a limited number of excipient suppliers can create vulnerabilities.
• Quality Failures: Deviations from GMP at any stage of manufacturing, from API synthesis to finished product packaging, can lead to product recalls and regulatory actions.
• Geopolitical Instability: Manufacturing sites located in regions prone to political unrest or natural disasters face increased risk.
• Regulatory Changes: Evolving regulatory requirements for manufacturing, quality control, or supply chain security can necessitate significant adjustments.
• Counterfeiting: The over-the-counter nature of the product makes it a potential target for counterfeiters, necessitating robust supply chain security measures.

Key Takeaways

• Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, is the primary marketing authorization holder for MONISTAT 3 COMBINATION PACK.
• The product contains Miconazole Nitrate as the active antifungal agent, along with excipients Hydroxypropyl Methylcellulose and White Petrolatum.
• Key global suppliers for Miconazole Nitrate include BASF SE, Aarti Industries Limited, and Shandong Xinhua Pharmaceutical Co., Ltd.
• Major suppliers for Hydroxypropyl Methylcellulose include DuPont de Nemours, Inc., Shin-Etsu Chemical Co., Ltd., and Ashland Inc.
• Prominent suppliers for White Petrolatum include ExxonMobil Corporation and Royal Dutch Shell plc.
• Finished product manufacturing is likely conducted by contract manufacturers or Johnson & Johnson's internal facilities, adhering to strict cGMP standards.
• The entire supply chain is governed by rigorous regulatory frameworks including cGMP and ICH guidelines.
• Critical sourcing considerations include API/excipient quality, purity, regulatory compliance, supply chain reliability, and cost-effectiveness.

FAQs

1. What are the specific quality standards for pharmaceutical-grade White Petrolatum used in MONISTAT 3 COMBINATION PACK? Pharmaceutical-grade White Petrolatum must meet specifications outlined in pharmacopoeias such as the United States Pharmacopeia (USP) or the European Pharmacopoeia (EP). These standards define purity limits for contaminants, melting point, and other physical characteristics.

2. How does Johnson & Johnson ensure the quality of APIs sourced from global suppliers? Johnson & Johnson employs a multi-faceted approach including rigorous supplier qualification processes, regular site audits of manufacturing facilities, review of Drug Master Files (DMFs), and ongoing quality control testing of incoming API batches.

3. Are there any known shortages of Miconazole Nitrate that could impact MONISTAT 3 COMBINATION PACK availability? Information on specific API shortages is dynamic. Pharmaceutical companies actively monitor supply chains and typically have multiple qualified suppliers and inventory management strategies to mitigate such risks.

4. What is the typical shelf-life of MONISTAT 3 COMBINATION PACK and how does it relate to the stability of its ingredients? The typical shelf-life of MONISTAT 3 COMBINATION PACK is established through rigorous stability testing conducted by the manufacturer. This testing assesses how the quality of the drug product, including the potency and integrity of its active ingredients and excipients, changes over time under various environmental conditions.

5. Can a patient directly purchase Miconazole Nitrate API for personal use? No. Miconazole Nitrate API is a pharmaceutical ingredient that can only be legally manufactured, distributed, and sold to licensed pharmaceutical manufacturers for incorporation into approved drug products. It is not available for direct purchase by individuals.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP) for Drugs. Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/current-good-manufacturing-practice-cgmp

[2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from https://www.ich.org/page/guidelines