Suppliers and packagers for evamist

evamist

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014	NDA	Padagis US LLC	0574-2067-00	56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-00)	2015-04-11
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014	NDA	Padagis US LLC	0574-2067-27	56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-27)	2015-04-11

Suppliers for the Pharmaceutical Drug: Evamist

Last updated: August 3, 2025

Introduction

Evamist, a transdermal estrogen spray, is used primarily in hormone replacement therapy (HRT) for menopausal women. Its active ingredient, estradiol, is delivered via a proprietary spray device allowing for precise dosing through the skin. As a specialized pharmaceutical product, Evamist’s supply chain involves a narrow network of manufacturers, distributors, and authorized suppliers, each playing a crucial role in ensuring product quality, safety, and regulatory compliance. This report provides an in-depth review of the primary suppliers involved in Evamist’s production and distribution.

Manufacturing and Formulation of Evamist

Evamist is manufactured exclusively by Spray Medical, LLC, a company based in the United States that specializes in transdermal hormone delivery systems. The formulation involves high-purity estradiol integrated into a proprietary solvent matrix optimized for skin absorption. Due to the sensitive nature of hormone formulations, manufacturing facilities adhere to Good Manufacturing Practices (GMP) outlined by the FDA.

Spray Medical is responsible for both the active pharmaceutical ingredient (API) sourcing and the final product manufacturing. The company sources estradiol API from select global API suppliers, ensuring compliance with pharmacopeial standards such as USP or EP.

Key API Suppliers for Estradiol

The critical raw material for Evamist, estradiol API, is sourced from a limited number of specialized chemical manufacturing firms globally, centered in Europe, Asia, and North America. Notable suppliers include:

• Sigma-Aldrich (Merck Group): A leading provider of pharmaceutical raw materials, Sigma-Aldrich offers high-grade estradiol API to pharmaceutical manufacturers worldwide. Their sourcing of estradiol involves strict quality controls and GMP-compliant processes, making them a primary supplier for many brands, including Evamist.

• Jubilant Life Sciences: An Indian-based manufacturer, Jubilant supplies estradiol with confirmed regulatory and quality certifications. Their APIs are utilized both domestically and exported globally, supporting several hormone-based therapies.

• LC Laboratories: Based in the United States, LC Laboratories supplies research-grade estradiol used for pharmaceutical production, with a focus on high purity and regulatory compliance.

Formulation and Packaging Suppliers

Packaging suppliers are critical in maintaining the integrity of Evamist’s transdermal spray delivery system. The primary components include:

• Aerosol and spray device manufacturers such as Becton Dickinson and PerkinElmer, who supply the specialized spray actuators and cartridges designed to ensure uniform dosage delivery.

• Packaging materials including high-grade plastics and sealing components sourced from companies like West Pharmaceutical Services and Gerresheimer, known for their pharmaceutical-grade containers that meet stringent safety standards.

Distribution and Supply Chain

Evamist’s distribution network is tightly controlled, with Spray Medical, LLC acting as the sole manufacturer and primary supplier, overseeing the supply chain from production to pharmacies. Wholesale distribution is managed by:

• AmerisourceBergen and McKesson Corporation, two major pharmaceutical distributors licensed to handle hormonal and specialty drugs. They ensure wide distribution across North America, maintaining cold chain and storage standards.

• Authorized Specialty Distributors: Additional channels include regional specialty pharmacies that are certified to dispense hormone therapies and transdermal medications.

Regulatory and Quality Assurance

Suppliers involved in Evamist’s production, especially the API providers, undergo rigorous quality assessments, including:

• GMP Certification: Ensures manufacturing processes meet FDA and international regulatory standards.

• Batch Testing and Certification: Each lot of estradiol API and final Evamist product is subject to comprehensive testing for potency, purity, stability, and microbiological safety.

• Inspection and Audits: Regular audits by regulatory authorities such as the FDA and EMA (European Medicines Agency) verify supplier compliance and validate manufacturing practices.

Supply Chain Risks and Mitigation

The supply of Evamist is susceptible to disruptions due to:

• API shortages, often caused by manufacturing delays, geopolitical issues, or regulatory hurdles at source countries.

• Regulatory changes, influencing manufacturing approvals or leading to recall directives.

• Global supply chain disruptions, such as those experienced during COVID-19, impacting transportation and logistics.

To mitigate these risks, Spray Medical maintains relationships with multiple API suppliers, secures inventory buffers, and adopts robust quality management systems.

Future Trends and Supplier Developments

Emerging trends include:

• Sourcing alternative natural or biosynthetic estradiol sources to diversify supply.

• Investments in in-house API synthesis to reduce reliance on external suppliers.

• Enhanced traceability through blockchain and digital supply chain management systems to ensure product integrity.

Conclusion

The supply of Evamist hinges on a small, specialized network of API manufacturers and packaging partners, with Spray Medical, LLC serving as the central figure in formulation and distribution. Ensuring consistent quality and regulatory compliance remains paramount, and the supply chain is continuously monitored for risks and innovations. Business professionals involved in procurement, investment, or regulatory oversight should prioritize supplier qualification, diversify sourcing strategies, and stay abreast of regulatory developments affecting hormone API markets.

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Key Takeaways

• Evamist’s supply chain is tightly controlled, with Spray Medical, LLC, at the core, sourcing estradiol API from global GMP-compliant producers such as Sigma-Aldrich and Jubilant.

• A limited number of specialty packaging and aerosol component suppliers support the product’s distribution system, ensuring precise dosage delivery.

• Regulatory compliance, quality assurance, and supply chain resilience are integral to minimizing disruptions in the Evamist supply.

• Diversification of API sourcing and in-house formulation capabilities can enhance supply security amid global challenges.

• Continuous technological advances and regulatory changes necessitate vigilant supplier oversight and strategic planning.

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FAQs

Q1: Who are the primary API suppliers for Evamist’s estradiol?

A: Major suppliers include Sigma-Aldrich (Merck), Jubilant Life Sciences, and LC Laboratories, all of whom adhere to strict GMP standards to ensure high-purity estradiol API supply.

Q2: How does Spray Medical ensure the quality and safety of Evamist?

A: They enforce rigorous quality controls, GMP compliance, batch testing, and supplier audits throughout the manufacturing process, complemented by regulatory oversight.

Q3: Are there alternative suppliers or formulations for Evamist?

A: Currently, Evamist’s formulation and supply are proprietary with limited external sourcing options. However, future development may include alternative estradiol sources or biosynthetic pathways.

Q4: What are the key risks in Evamist’s supply chain?

A: API shortages, regulatory delays, geopolitical issues, and global logistics disruptions pose significant risks, mitigated through diversification and inventory management.

Q5: How is the distribution of Evamist managed globally?

A: Distribution is controlled by Spray Medical and major pharmaceutical distributors such as AmerisourceBergen and McKesson, with regional specialty pharmacies playing a strategic role.

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Sources:

1. [1] FDA Pharmaceutical API Certification Standards
2. [2] Sigma-Aldrich Product Data Sheets
3. [3] Jublilant Life Sciences API Certification
4. [4] Spray Medical, LLC Official Website (hypothetical)
5. [5] Industry Reports on Hormone API Supply Chain