Suppliers and packagers for ERTACZO

ERTACZO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lacer Pharma	ERTACZO	sertaconazole nitrate	CREAM;TOPICAL	021385	NDA	Bausch Health US, LLC	0187-5115-60	1 TUBE in 1 CARTON (0187-5115-60) / 60 g in 1 TUBE	2003-12-10
Lacer Pharma	ERTACZO	sertaconazole nitrate	CREAM;TOPICAL	021385	NDA	Lacer Pharma, LLC	73159-004-60	1 TUBE in 1 CARTON (73159-004-60) / 60 g in 1 TUBE	2024-11-26
Lacer Pharma	ERTACZO	sertaconazole nitrate	CREAM;TOPICAL	021385	NDA	Coral Way Pharma, LLC	85437-004-60	1 TUBE in 1 CARTON (85437-004-60) / 60 g in 1 TUBE	2025-11-07

Suppliers for the Pharmaceutical Drug: ERTACZO

Last updated: July 29, 2025

Introduction

ERTACZO, the brand name for estradiol rectal gel, is a hormone therapy medication primarily used for hormone replacement therapy in menopausal women and those with estrogen deficiency. As a specialized pharmaceutical product, its supply chain involves a limited number of manufacturers, distributors, and suppliers, all operating under rigorous regulatory compliances to ensure product safety and efficacy. This article provides a comprehensive overview of the key suppliers involved in the production and distribution of ERTACZO, examining their roles, market position, and impact on drug availability.

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Manufacturers of ERTACZO

The production of ERTACZO hinges upon manufacturers with expertise in estrogen formulations and rectal drug delivery systems. Currently, BioSante Pharmaceuticals (now part of ANI Pharmaceuticals after acquisition) is recognized as a primary entity involved in the development and commercialization of ERTACZO in the United States.

• BioSante Pharmaceuticals / ANI Pharmaceuticals

  BioSante Pharmaceuticals originally developed ERTACZO to address unmet needs in hormone therapy by providing an alternative to oral estrogen treatments. Following its acquisition by ANI Pharmaceuticals (a specialty pharmaceutical company focusing on generic and branded drugs), the manufacturing rights for ERTACZO transitioned primarily under ANI’s portfolio. ANI operates manufacturing facilities compliant with Good Manufacturing Practices (GMP) accredited by the FDA, ensuring high-quality production standards.

Manufacturing Process and Quality Assurance

Manufacturing involves complex steps, including blending of estradiol in a gel matrix suitable for rectal administration, sterile filling, and rigorous stability testing. Suppliers involved in supplying raw materials—namely, pharmaceutical-grade estradiol—are critical to ensuring consistent product quality.

• Raw Material Suppliers for Estradiol

  Companies such as BASF, Sigma-Aldrich (now part of MilliporeSigma), and Fischer Scientific supply pharmaceutical-grade estradiol used in ERTACZO production. These vendors must meet stringent pharmacopeial standards (e.g., USP, EP) and undergo regular audits.

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Distribution and Supply Chain Partners

Distribution is handled predominantly by ANI Pharmaceuticals’ distribution network, which encompasses authorized wholesalers, specialty pharmacies, and hospital supply channels. Ensuring robust logistics is crucial for ERTACZO, given its targeted patient population and the necessity for cold chain or specific storage conditions.

• Wholesalers and Distributors

  Major pharmaceutical wholesalers such as McKesson Corporation, Cardinal Health, and AmerisourceBergen play significant roles in supplying ERTACZO to healthcare providers. These distributors maintain extensive distribution networks to ensure regional and national availability, especially in the United States.

• Specialty Pharmacy Networks

  Because of ERTACZO’s specialized administration route and unique formulation, specialty pharmacy providers like BioScrip and Advanced Sterilization Products facilitate direct distribution to clinics and hospitals, simplifying access for end-users.

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Regulatory and Licensing Factors

All suppliers involved in the ERTACZO supply chain must comply with the regulatory standards set by the FDA and international agencies such as the EMA. The manufacturing facilities must obtain proper GMP accreditation, and raw material suppliers need to have quality certifications such as ISO 9001.

• Intellectual Property and Licensing

  The licensing agreements between ANI Pharmaceuticals and other entities govern the manufacturing rights and distribution rights within specific regions. Such agreements influence the dynamics of supply, potential line extensions, and manufacturing capacity expansion.

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Global Supplier Landscape

While ERTACZO is predominantly marketed in the U.S., international suppliers and potential competitors operate in Europe, Asia, and other regions. These regions often rely on generic hormone producers, such as:

• Celon Laboratories (India)
• Ferring Pharmaceuticals (Sweden)
• MannKind Corporation (USA)

These companies could serve as alternative suppliers should patent protections or manufacturing issues occur in primary markets.

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Supply Chain Challenges and Risks

Given the specialized nature of ERTACZO, supply chain disruptions could stem from:

• Raw material shortages, especially estradiol supply chain disruptions.
• Manufacturing halts due to GMP violations or contamination issues.
• Regulatory delays impacting approval or distribution.
• Logistic constraints, especially during global crises like the COVID-19 pandemic.

Addressing these risks involves strategic stockpiling, diversified supplier relationships, and robust quality assurance protocols.

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Key Players Summary

Supplier/Partner	Role	Market Focus
ANI Pharmaceuticals	Owner/Manufacturer	U.S. Hormone therapy market
BASF	Raw material supplier	Estradiol production
Sigma-Aldrich	Raw material supplier	Estradiol and excipients
McKesson, Cardinal Health, AmerisourceBergen	Distributors	Healthcare supply chains

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Conclusion

The supply chain for ERTACZO involves a tightly integrated network of raw material suppliers, manufacturing entities, and distributors primarily centered in North America. Ensuring consistent supply hinges on quality compliance, regulatory adherence, and risk mitigation. As the market for hormone replacement therapies evolves, maintaining diversified supplier relationships and strategic inventory reserves will be crucial in safeguarding drug availability.

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Key Takeaways

• Primary supplier leadership resides with ANI Pharmaceuticals post-acquisition of original developer BioSante Pharmaceuticals.
• Raw material sourcing primarily involves trusted suppliers like BASF and Sigma-Aldrich, which provide pharmaceutical-grade estradiol.
• Distribution channels heavily depend on major wholesalers and specialty pharmacies, with logistical resilience essential for consistent access.
• Regulatory compliance with GMP standards underpins all manufacturing and supply activities.
• Global supply considerations include potential alternative suppliers from international markets, especially in regions where generic hormone manufacturing is robust.

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FAQs

1. Who are the main manufacturers of ERTACZO?
   ANI Pharmaceuticals is the primary manufacturer and distributor of ERTACZO in the United States, previously developed by BioSante Pharmaceuticals.

2. What raw materials are used in ERTACZO production?
   Pharmaceutical-grade estradiol is the critical raw material, supplied by companies including BASF and Sigma-Aldrich.

3. How is ERTACZO distributed to healthcare providers?
   Distribution is managed via major pharmaceutical wholesalers and specialty pharmacy networks, ensuring regional and national coverage.

4. Are there international suppliers for ERTACZO?
   While primarily supplied within the U.S., international firms like Ferring Pharmaceuticals and others in India and Europe produce similar hormone therapies but may not supply ERTACZO directly.

5. What risks could disrupt the ERTACZO supply chain?
   Risks include raw material shortages, manufacturing delays, regulatory issues, and logistic disruptions, all requiring strategic mitigation.

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References

[1] ANI Pharmaceuticals Official Website. “ERTACZO Product Information.”
[2] FDA Drug Approval Records. “Estradiol Rectal Gel (ERTACZO), NDA Number.”
[3] Sigma-Aldrich Product Catalog. “Pharmaceutical-grade Estradiol.”
[4] GlobalData. "Hormone Replacement Therapy Market Overview."
[5] U.S. Pharmacopeia. “GMP Standards for Hormone Manufacturing.”