Suppliers and packagers for PHEXXI

PHEXXI

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352	NDA	Evofem, Inc.	69751-100-03	3 APPLICATOR in 1 BOX (69751-100-03) / 5 g in 1 APPLICATOR (69751-100-01)	2020-08-01
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352	NDA	Evofem, Inc.	69751-100-12	12 APPLICATOR in 1 BOX (69751-100-12) / 5 g in 1 APPLICATOR (69751-100-01)	2020-08-01
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352	NDA	Evofem, Inc.	69751-101-12	12 APPLICATOR in 1 BOX (69751-101-12) / 5 g in 1 APPLICATOR (69751-101-01)	2020-08-01

Suppliers for the Pharmaceutical Drug: PHEXXI

Last updated: July 28, 2025

Introduction

PHEXXI is a prescription-only, hormone-free contraceptive gel developed and marketed by HRA Pharma (a subsidiary of Perrigo) in the United States. Approved by the FDA in 2020, PHEXXI presents an innovative approach to contraception by utilizing a unique formulation of lactic acid, citric acid, and potassium bitartrate to maintain vaginal pH and prevent sperm migration. Its market promise hinges on the reliable supply chain of its active ingredients, excipients, and manufacturing services. This analysis explores the key suppliers involved in PHEXXI’s manufacturing, their roles, and the implications for stakeholders.

Key Components and Supply Chain Dynamics

To understand the supplier landscape, it is essential to delineate the critical components of PHEXXI and their sourcing prerequisites:

• Active and excipient ingredients: The formulation comprises three acids—lactic acid, citric acid, and potassium bitartrate.
• Packaging materials: The gel is supplied in single-dose applicators requiring specialized pharmaceutical-grade plastics.
• Manufacturing services: Contract manufacturing organizations (CMOs) often produce complex formulations.

Lactic Acid Suppliers

Lactic acid functions as the primary agent maintaining vaginal pH. It is derived via fermentation processes involving carbohydrate substrates such as corn or sugarcane.

• Major global suppliers:
  • Corbion (Netherlands): A leader in lactic acid production, offering pharmaceutical-grade lactic acid suitable for sensitive formulations. Their production facilities are compliant with FDA and EMA standards.
  • Musashino Chemical Laboratory (Japan): Specializes in high-purity lactic acid for pharmaceutical applications, including formulations like PHEXXI.
  • Henan Jindan Lactic Acid Technology Co. Ltd (China): Produces large volumes of lactic acid, though sourcing from Chinese suppliers may involve careful validation due to varying quality standards.

Citric Acid Suppliers

Citric acid is commonly produced through fermentation of Aspergillus niger or via chemical synthesis.

• Leading suppliers:
  • Cargill (USA/Global): Supplies pharmaceutical-grade citric acid produced under stringent quality controls.
  • Archer Daniels Midland (ADM, USA): Offers high-purity citric acid compatible with pharmaceutical standards.
  • Yidu Greenpharm (China): Provides certified pharmaceutical-grade citric acid for domestic and international markets.

Potassium Bitartrate (Cream of Tartar) Suppliers

Potassium bitartrate, a natural byproduct of wine fermentation, is widely available but must meet pharmaceutical standards for PHEXXI.

• Key suppliers:
  • Givaudan (Switzerland): Known for specialty ingredients, including pharmaceutical-grade tartaric salts.
  • Shaanxi Fuheng (Fuheng Chemical Co., China): Produces different grades of potassium bitartrate aligned with pharmaceutical manufacturing uses.
  • Roquette (France): Provides pharmaceutical-grade tartaric acid salts.

Packaging Material Suppliers

• Specialized plastics company Gerresheimer supplies pharmaceutical-grade plasticized applicators suitable for PHEXXI’s single-dose delivery system.
• Other notable suppliers include West Pharmaceutical Services and Nipro PharmaPackaging, offering compliance-certified packaging components.

Contract Manufacturing and Formulation Development

While Perrigo primarily handles PHEXXI manufacturing internally, many pharmaceutical companies outsource formulation development and batch production to CMOs such as:

• Aesica Pharmaceuticals: Known for sterile and non-sterile contract manufacturing aligned with FDA regulations.
• Famar: Provides pharmaceutical contract manufacturing services, including gel formulation and filling.
• Recipharm: Offers comprehensive manufacturing solutions with a focus on topical and vaginal formulations.

Sourcing Challenges and Quality Assurance

The sourcing of raw ingredients like lactic acid and citric acid requires rigorous validation to ensure compliance with US Pharmacopeia standards. Suppliers must demonstrate:

• Good Manufacturing Practice (GMP) compliance.
• Certificates of analysis (CoA).
• Validation of active ingredient purity (>99% pharmaceutical grade).
• Traceability and robust quality control procedures.

Supply chain disruptions—such as raw material shortages, geopolitical issues, or transportation delays—can impact PHEXXI’s production scheduling and market availability, underscoring the importance of diversified sourcing strategies.

Implications for Stakeholders

• Manufacturers: Must establish deep relationships with multiple qualified suppliers to mitigate risks.
• Regulators: Require evidence of supplier qualification and ongoing quality audits.
• Distributors and pharmacies: Depend on stable supply chains for consistent product availability.
• End-users: Rely on manufacturing integrity to ensure product safety and efficacy.

Future Outlook

As demand for non-hormonal contraceptives like PHEXXI increases, the supplier ecosystem is expected to expand, with potential vertical integration or strategic partnerships. The rise in API manufacturing capacity and advances in fermentation technologies may lead to more resilient supply networks, reducing vulnerability to raw material shortages.

Key Takeaways

• The primary suppliers for PHEXXI include Corbion (lactic acid), Cargill and ADM (citric acid), and Givaudan (potassium bitartrate).
• Ensuring GMP compliance and high purity standards is crucial for all raw material suppliers.
• Diversification of sourcing and establishing strong supplier relationships mitigate supply risks.
• Contract manufacturing organizations (CMOs) play an integral role in formulation, production, and packaging.
• Ongoing supply chain monitoring and quality assurance are essential to meet regulatory standards and ensure consistent product delivery.

FAQs

1. Who are the main raw material suppliers for PHEXXI?
Corbion supplies pharmaceutical-grade lactic acid; Cargill and ADM provide high-purity citric acid; Givaudan offers potassium bitartrate suitable for pharmaceutical use.

2. What criteria do suppliers need to meet for PHEXXI production?
Suppliers must comply with GMP standards, provide certificates of analysis confirming high purity (>99%), and demonstrate rigorous quality control processes.

3. Are there risks associated with sourcing from specific regions?
Yes. Dependence on suppliers from China or other regions may pose risks related to geopolitical tensions, tariffs, or regulatory differences, emphasizing the importance of diversification.

4. How does Perrigo ensure raw material quality?
Through comprehensive supplier qualification, regular audits, strict quality assurance protocols, and batch testing to ensure compliance with pharmacopeial standards.

5. What is the outlook for the supply chain of PHEXXI?
The supply chain is poised for growth with increased capacity in fermentation-based ingredient production and strengthened relationships with key suppliers, reducing vulnerabilities.

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Sources:

1. FDA Approval Document for PHEXXI, U.S. Food & Drug Administration, 2020.
2. Corbion Corporate Website.
3. Cargill Pharma Ingredients Portfolio.
4. Givaudan Product Literature.
5. Industry Reports on Pharmaceutical Raw Material Supply Chains.