Suppliers and packagers for VAGIFEM

VAGIFEM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908	NDA	Novo Nordisk	0169-5176-03	8 APPLICATOR in 1 CARTON (0169-5176-03) / 1 INSERT in 1 APPLICATOR	2010-01-11
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908	NDA	Novo Nordisk	0169-5176-04	18 APPLICATOR in 1 CARTON (0169-5176-04) / 1 INSERT in 1 APPLICATOR	2010-01-11
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908	NDA	Novo Nordisk	0169-5176-99	6 APPLICATOR in 1 CARTON (0169-5176-99) / 1 INSERT in 1 APPLICATOR	2010-01-11

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: VAGIFEM

Introduction

VAGIFEM is a topical hormonal treatment containing estradiol hemihydrate, primarily prescribed for the management of moderate to severe dyspareunia and atrophic vaginitis in postmenopausal women. As a locally administered estrogen therapy, VAGIFEM has garnered interest from healthcare providers and pharmaceutical supply chains worldwide. Understanding its supply landscape, including principal manufacturers, authorized distributors, and potential sourcing channels, is critical for pharmaceutical stakeholders aiming to secure reliable procurement pathways.

Overview of VAGIFEM

VAGIFEM (estradiol hemihydrate) is marketed as a vaginal insert or topical cream, often prescribed as part of hormone replacement therapy (HRT). It is frequently produced by specialized pharmaceutical firms authorized to manufacture estrogen-based therapies. Its patent and regulatory status influence the scope and number of authorized suppliers, often resulting in a limited pool of licensed producers.

Key Manufacturers and Authorized Suppliers

The primary manufacturer of VAGIFEM is Novo Nordisk, a global leader in reproductive health and hormone therapies. Novo Nordisk, under various regional subsidiaries, is responsible for the commercialization and distribution of VAGIFEM in multiple markets, including North America, Europe, and Asia. The company holds regulatory approvals from agencies such as the US FDA and EMA, ensuring compliance with stringent manufacturing and quality standards.

Novo Nordisk's Role:

• Originates and markets VAGIFEM as part of its hormone therapy portfolio.
• Ensures supply through its extensive distribution network, partnering with authorized wholesalers and pharmacies.
• Maintains global manufacturing facilities compliant with Good Manufacturing Practice (GMP) standards.

Regional Distributors and Licensed Wholesalers:
In addition to the primary manufacturer, regional distribution agreements enable local pharmacies and hospitals to procure VAGIFEM through licensed wholesale partners. These entities are approved by local healthcare agencies and adhere to regional pharmaceutical regulations to ensure product authenticity and safety.

Regulatory and Certification Considerations

Supply chains for VAGIFEM are tightly regulated to prevent counterfeit and substandard products. Distribution is typically governed by regional regulatory agencies such as the FDA (United States), EMA (European Union), or PMDA (Japan). These agencies require licensed manufacturing, proper labeling, and traceability of the product, which limits sourcing to authorized suppliers only.

Potential Sources of VAGIFEM

1. Direct from Manufacturer:
   • Novo Nordisk supplies VAGIFEM directly to authorized distributors and large healthcare entities. Securing direct procurement ensures product authenticity and efficient supply chain management.
2. Authorized Regional Distributors:
   • Licensed pharmaceutical distributors in specific countries or territories, such as Alphapharm in Australia or Centrafarm in Europe, are approved channels for VAGIFEM distribution.
3. Pharmacies and Hospitals:
   • In most markets, VAGIFEM is available via licensed pharmacies following prescription, sourcing from regional wholesalers.
4. Online Pharmaceutical Distributors:
   • Some online pharmacies, especially in regions with established regulatory oversight, procure VAGIFEM from authorized sources. However, caution is advised to ensure product authenticity and compliance.

Emerging Suppliers and Market Dynamics

Despite the dominance of Novo Nordisk, the landscape may evolve with generic formulations entering the market post-patent expiry, depending on regional patent laws and regulatory approvals. Generic manufacturers with appropriate regulatory clearance may supply bioequivalent estrogen therapies, potentially impacting supply sourcing options. However, currently, VAGIFEM remains primarily supplied by Novo Nordisk and its authorized partners.

Supply Chain Challenges and Considerations

• Regulatory hurdles: Strict regional approval processes may limit the emergence of new suppliers.
• Manufacturing capacity: As a specialized hormonal therapy, manufacturing capacity may be constrained, leading to potential shortages.
• Regional availability: Not all markets have immediate access to VAGIFEM, necessitating careful planning for supply chain continuity.
• Counterfeit risk: Due to high demand and sensitive nature, counterfeit products pose a risk; sourcing solely from authorized suppliers mitigates this issue.

Conclusion

The supply chain of VAGIFEM is predominantly controlled by Novo Nordisk, supported by licensed regional distributors who comply with regional regulatory standards. Ensuring a reliable supply necessitates engaging with authorized channels to guarantee authenticity, safety, and regulatory compliance. As the market evolves, potential entrants such as generic manufacturers may expand the supplier base, but current procurement remains centered on well-established, reputable sources.

Key Takeaways

• Primary Supplier: Novo Nordisk is the main manufacturer and principal supplier of VAGIFEM globally.
• Authorized Distributors: Rely on licensed regional wholesalers and distributors compliant with local regulatory standards.
• Regulatory Compliance: Only procure from suppliers with proper authorization to mitigate risks related to counterfeit or substandard products.
• Market Dynamics: The emergence of generic alternatives may affect supply options in the future but are predominantly regulated.
• Supply Chain Assurance: Establish direct relationships with manufacturers or authorized distributors to ensure continuity and product authenticity.

FAQs

Q1: Is VAGIFEM available from multiple manufacturers globally?
A1: Currently, VAGIFEM is primarily produced and supplied by Novo Nordisk. Generic versions or bioequivalents may emerge post-patent expiration, but availability is largely limited to authorized sources.

Q2: How can healthcare providers ensure they source genuine VAGIFEM?
A2: Providers should procure VAGIFEM through licensed, authorized regional distributors or directly from Novo Nordisk, ensuring traceability and compliance with regulatory standards.

Q3: Are there regional differences in VAGIFEM suppliers?
A3: Yes. While Novo Nordisk supplies globally, regional distributors vary based on licensing agreements, regulatory approvals, and market access strategies.

Q4: Can online pharmacies reliably supply VAGIFEM?
A4: Only if verified as licensed and authorized by relevant regulatory bodies. Consumers should exercise caution and verify authenticity to avoid counterfeit products.

Q5: Will the supplier landscape for VAGIFEM change soon?
A5: Future changes depend on patent expirations and market approval of generics. Currently, the supply landscape remains stable with Novo Nordisk as the primary supplier.

References

1. Novo Nordisk. VAGIFEM Product Information. Accessed 2023.
2. U.S. Food and Drug Administration (FDA). Approved Drug Products.
3. European Medicines Agency (EMA). VAGIFEM Market Authorization.
4. GlobalData Pharma Intelligence. Market Analysis Reports.
5. World Health Organization (WHO). International Standards for Hormonal Therapies.