Bulk Pharmaceutical API Sources for MONISTAT 3 COMBINATION PACK (PREFILLED)

Bulk Pharmaceutical API Sources for MONISTAT 3 COMBINATION PACK (PREFILLED)

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M3512_SIGMA
TCI (Tokyo Chemical Industry)		M1769
Molport		MolPort-003-665-537
Amadis Chemical		A816380
TimTec		SBB057009

Bulk Active Pharmaceutical Ingredient (API) Sources for Monistat 3 Combination Pack (Prefilled)

Last updated: August 2, 2025

Introduction

The Monistat 3 Combination Pack is a popular antifungal treatment designed for the management of vaginal yeast infections. It typically contains a combination of active pharmaceutical ingredients (APIs), notably Miconazole nitrate as the antifungal agent, combined with other excipients or formulation components to facilitate drug delivery. Sourcing high-quality bulk APIs for manufacturing the Monistat 3 combination pack necessitates understanding key API specifications, reliable suppliers, and regulatory compliance. This comprehensive analysis details suitable sources of APIs involved in the formulation, focusing on Miconazole nitrate, excipients, and relevant quality standards to ensure product efficacy, safety, and regulatory adherence.

---

Active Pharmaceutical Ingredients in Monistat 3

The pivotal API in Monistat 3 is Miconazole nitrate, an imidazole antifungal agent. It is responsible for the antimycotic activity against Candida species. The formulation also includes inactive ingredients such as carbomer or other gels, but in the context of drug sourcing, the focus remains on APIs.

Miconazole Nitrate: Overview

Miconazole nitrate is a broad-spectrum antifungal agent effective against yeasts and dermatophyte fungi. It inhibits fungal cytochrome P450-dependent enzymes, impairing fungal cell membrane synthesis. The usual dose in Monistat 3 is 200 mg per vaginal ovule, administered over three days.

Key Specifications:

• Manufacturing standards: Typically conforms to USP, EP, or JP monographs.
• API quality: Must meet high purity standards (>99%), with validated residual solvent levels, heavy metals, and microbial limits.
• Melting point: Approximately 89-92°C.
• Solubility: Slightly soluble in water; more soluble in organic solvents like ethanol.

---

Source Identification for Miconazole Nitrate

1. Major API Suppliers

Reliable procurement of miconazole nitrate involves engaging with established, GMP-compliant manufacturers with proven regulatory track records.

a. Hangzhou Tiancheng Pharmaceutical Co., Ltd. (China)

• Credentials: Certified by ISO, GMP, and has a reputation for producing high-purity APIs.
• Product Range: Offers pharmaceutical-grade miconazole nitrate with comprehensive certification and documentation aligned with USP/EP standards.
• Advantages: Competitive pricing, consistent supply, and suitable for large-scale manufacturing.

b. Hubei Zhensheng Pharmaceutical Co., Ltd. (China)

• Certifications: GMP, ISO, and customer-specific quality assurance.
• Product Focus: Emphasis on antifungal APIs with proven bioavailability and stability profiles.
• Supply Capabilities: Offers APIs conforming to international pharmacopoeias conducive for finished dosage forms like Monistat 3.

c. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

• Reputation: One of the leading Chinese API manufacturers with extensive R&D.
• Quality Standards: Meets or exceeds USP and EP monograph specifications.
• Global Reach: Supplies to many multinational pharmaceutical companies.

d. Cambrex (USA)

• Overview: Well-established API manufacturer with USFDA approvals.
• Product Quality: Known for high purity APIs, including specialty antifungals.
• Regulatory Assurance: Complies with U.S. Good Manufacturing Practices, facilitating regulatory submissions globally.

e. Fareva (France)

• Reputation: Offers a wide range of pharmaceutical APIs with stringent quality controls.
• Strength: Extensive experience supplying APIs for over-the-counter and prescription medications.

---

2. Excipients and Formulation Components

Though APIs form the core, excipients such as gelling agents (e.g., carbomer), suspending agents, and preservatives are vital in the final product's stability and bioavailability. High-quality excipient sourcing is essential for consistent product quality.

Notable Suppliers:

• F.D.A.-approved excipient manufacturers like Dow Chemical, BASF, and Ashland supply pharmaceutical-grade excipients.
• Glyceryl monostearate and hydroxypropyl methylcellulose (HPMC): key for gel matrices.
• Preservatives such as parabens: sourced from certified chemical suppliers.

---

3. Regulatory and Quality Compliance

API sourcing must adhere to relevant pharmacopoeial standards:

• USP (United States Pharmacopeia)
• EP (European Pharmacopoeia)
• JP (Japanese Pharmacopoeia)

It is crucial to verify that suppliers furnish Certificate of Analysis (CoA), Device Master Files (DMF), and DMFs compliant with local regulatory authorities, such as the FDA, EMA, or PMDA.

---

4. Supply Chain and Reliability

Ensuring supply chain integrity involves assessing:

• Supplier certification: GMP, ISO 9001, and relevant pharmacopeial accreditation.
• Capacity: Ability to meet large volume demands for continuous manufacturing.
• Logistics: Stable and compliant distribution channels, especially for temperature-sensitive APIs.
• Regulatory support: Capacity to assist with regulatory filings for approvals.

---

Conclusion

Sourcing bulk APIs for Monistat 3 requires rigorous selection of manufacturers with proven quality standards and regulatory compliance. Key suppliers of Miconazole nitrate include Hangzhou Tiancheng Pharmaceutical, Zhejiang Hisun Pharmaceutical, Cambrex, and Fareva. These entities offer high-purity APIs validated to pharmacopoeial standards, suitable for scale-up and manufacturing of over-the-counter antifungal formulations like Monistat 3.

---

Key Takeaways

• Prioritize GMP-certified suppliers for APIs to ensure product safety and regulatory compliance.
• Verify API specifications align with pharmacopoeia standards (USP, EP, JP) before procurement.
• Establish a robust supply chain with suppliers capable of consistent quality and volume delivery.
• Incorporate high-quality excipients from reputable manufacturers to complement APIs in formulation development.
• Maintain comprehensive documentation, including Certificates of Analysis and compliance certificates, to facilitate regulatory approval processes.

---

FAQs

1. What are the primary considerations when sourcing Miconazole nitrate for Monistat 3?
Focus on API purity (>99%), compliance with pharmacopoeial standards, GMP certification, and consistent supply capability.

2. Are there alternative sources of Miconazole nitrate suitable for large-scale manufacturing?
Yes, manufacturers like Cambrex and Fareva provide high-quality APIs compliant with regulatory standards suitable for large-scale production.

3. What regulatory challenges exist when importing APIs for over-the-counter products like Monistat 3?
Regulatory agencies require detailed documentation, including CoA, manufacturing practices adherence, stability data, and sometimes DMFs to confirm API quality and safety.

4. How do excipient quality standards impact the final Monistat 3 product?
Excipients influence the product’s stability, bioavailability, and safety; thus, sourcing from certified, pharmaceutical-grade suppliers is critical.

5. Can biosimilar or generic APIs replace branded APIs in Monistat 3 formulations?
Biosimilar options are generally not applicable; however, generic APIs meeting pharmacopoeial standards are suitable for producing equivalent formulations.

---

Sources

[1] United States Pharmacopeia (USP) – Monographs and API specifications.
[2] European Pharmacopoeia (EP) – Monographs for antifungal APIs.
[3] Chinese API manufacturers' official websites and certifications.
[4] FDA Drug Master Files (DMF) database.
[5] Pharmaceutical regulatory guidelines for API sourcing and quality assurance.