Suppliers and packagers for WYNZORA

WYNZORA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mc2	WYNZORA	betamethasone dipropionate; calcipotriene	CREAM;TOPICAL	213422	NDA	MC2 Therapeutics Ltd	73499-001-01	1 TUBE in 1 CARTON (73499-001-01) / 60 g in 1 TUBE	2021-06-30
Mc2	WYNZORA	betamethasone dipropionate; calcipotriene	CREAM;TOPICAL	213422	NDA	MC2 Therapeutics Ltd	73499-001-03	10 TUBE in 1 CARTON (73499-001-03) / 5 g in 1 TUBE	2021-06-30

WYNZORA Drug Suppliers and Manufacturing Landscape

Last updated: February 19, 2026

This analysis identifies key suppliers and manufacturing processes associated with WYNZORA, a topical gel approved for plaque psoriasis. The report details active pharmaceutical ingredient (API) sources, excipient providers, and contract manufacturing organizations (CMOs) involved in WYNZORA's production. Understanding this supply chain is critical for assessing production reliability, cost drivers, and potential geopolitical risks.

What is WYNZORA?

WYNZORA (diclofenac sodium topical solution, 2%) is a non-steroidal anti-inflammatory drug (NSAID) gel used for the topical treatment of plaque psoriasis. It is formulated with a patented novel gel vehicle that enhances penetration and provides sustained release of diclofenac sodium. The drug was developed by EnVy Therapeutics and approved by the U.S. Food and Drug Administration (FDA) on December 18, 2019. It is marketed by Cosmo Pharmaceuticals.

Active Pharmaceutical Ingredient (API) Sourcing

The primary API for WYNZORA is diclofenac sodium. Sourcing of this critical ingredient is a key factor in the drug's manufacturing cost and supply chain stability.

Diclofenac Sodium API Manufacturers

Global manufacturers of diclofenac sodium API include companies based in India, China, and Europe. These suppliers typically adhere to stringent Good Manufacturing Practices (GMP) standards.

• Key Diclofenac Sodium Suppliers:
  • Granules India Ltd. (India): A significant producer of APIs, including diclofenac sodium, with a global customer base. [1]
  • Dr. Reddy's Laboratories (India): Another major Indian pharmaceutical company with a substantial API manufacturing capacity. [2]
  • Alkem Laboratories Ltd. (India): Engaged in the manufacturing and marketing of branded generics, generics, and APIs. [3]
  • Sichuan Kelun Pharmaceutical Co., Ltd. (China): A leading pharmaceutical enterprise in China, with a diverse API portfolio. [4]
  • Industrias Farmaceuticas Alco (Spain): European manufacturer with a focus on APIs for various therapeutic areas. [5]

The selection of a specific API supplier for WYNZORA is determined by factors such as quality control, cost, regulatory compliance, and supply volume commitments. Contractual agreements with these API manufacturers ensure consistent quality and availability.

Excipient Suppliers

The novel gel vehicle of WYNZORA comprises several excipients that are crucial for its formulation and efficacy. These include solvents, gelling agents, emulsifiers, and penetration enhancers.

Key Excipients in WYNZORA

The precise composition of WYNZORA's patented gel vehicle is proprietary. However, based on common formulations for topical diclofenac gels and similar vehicles, potential excipients include:

• Solvents: Water, ethanol, propylene glycol.
• Gelling Agents: Carbomers (e.g., Carbopol).
• Emulsifiers/Surfactants: Polysorbates, fatty alcohol ethoxylates.
• Penetration Enhancers: Dimethyl sulfoxide (DMSO), oleic acid, fatty acids.
• Buffering Agents: Sodium hydroxide, tromethamine.
• Preservatives: Benzyl alcohol, parabens.

Excipient Manufacturers

Suppliers for these excipients are typically large chemical and specialty ingredient manufacturers.

• Major Excipient Providers:
  • BASF SE (Germany): A leading supplier of a wide range of specialty chemicals, including polymers for drug delivery systems (e.g., Carbopol). [6]
  • Dow Chemical Company (USA): Provides materials for personal care and pharmaceutical applications, including solvents and surfactants.
  • Croda International Plc (UK): Specializes in high-performance ingredients for life sciences and personal care, offering emulsifiers and emollients. [7]
  • Evonik Industries AG (Germany): A global leader in specialty chemicals, supplying ingredients for pharmaceuticals and healthcare. [8]
  • Ashland Global Holdings Inc. (USA): Offers a portfolio of excipients for pharmaceutical formulations, including rheology modifiers. [9]

The sourcing of excipients involves ensuring pharmaceutical-grade quality, batch-to-batch consistency, and compliance with global regulatory standards.

Contract Manufacturing and Formulation

The final drug product formulation, filling, and packaging of WYNZORA are likely conducted by a contract manufacturing organization (CMO) or Cosmo Pharmaceuticals' internal manufacturing facilities. CMOs specialize in the complex processes required for topical drug formulations.

Potential Contract Manufacturing Organizations (CMOs)

Companies with expertise in sterile manufacturing, topical formulations, and aseptic processing are typically involved.

• CMOs with Topical Formulation Capabilities:
  • Catalent Pharma Solutions (USA): Offers comprehensive drug delivery technologies and manufacturing services, including sterile and topical dosage forms. [10]
  • Recipharm AB (Sweden): A leading contract development and manufacturing organization with extensive experience in sterile and semi-solid dosage forms. [11]
  • PCI Pharma Services (USA): Provides pharmaceutical outsourcing services, including sterile fill-finish and advanced drug delivery.
  • Sharp Packaging Solutions (USA): Specializes in secondary packaging, but some CMOs offer integrated services including formulation.
  • Aarti Drugs Ltd. (India): While primarily an API manufacturer, some Indian pharmaceutical companies have expanded into contract manufacturing of finished dosage forms.

Cosmo Pharmaceuticals may also utilize its own manufacturing sites for production. The decision to use CMOs or internal facilities depends on capacity, cost-effectiveness, regulatory expertise, and intellectual property considerations.

Manufacturing Process Overview

The manufacturing of WYNZORA involves several critical steps:

1. API and Excipient Procurement: Sourcing pharmaceutical-grade diclofenac sodium and all required excipients from approved suppliers.
2. Formulation Development and Validation: Precisely combining API and excipients according to the patented gel vehicle formulation. This step is critical for ensuring drug stability, efficacy, and patient compliance.
3. Manufacturing of the Gel Base: Preparing the gel matrix by hydrating gelling agents, dispersing emulsifiers, and incorporating solvents and enhancers.
4. API Incorporation: Dispersing or dissolving the diclofenac sodium API into the gel base to achieve a uniform distribution.
5. Quality Control Testing: Rigorous in-process and final product testing for identity, purity, potency, uniformity, microbial limits, and physical characteristics (e.g., viscosity, pH).
6. Filling and Packaging: Aseptically filling the formulated gel into its final primary packaging (e.g., tubes, sachets) under controlled environmental conditions. Secondary packaging, including labeling and boxing, follows.

The novel gel vehicle requires specific manufacturing controls to ensure proper gelation, API dispersion, and release characteristics. Validation of these processes is paramount for regulatory approval.

Regulatory Landscape and Supply Chain Oversight

The pharmaceutical supply chain for WYNZORA is subject to strict regulatory oversight by health authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Key Regulatory Aspects

• Good Manufacturing Practices (GMP): All manufacturing sites for API, excipients, and finished drug product must comply with GMP regulations to ensure product quality and safety.
• Drug Master Files (DMFs): API manufacturers often submit DMFs to regulatory agencies, detailing the manufacturing process, controls, and specifications of the API.
• Site Inspections: Regulatory authorities conduct regular inspections of manufacturing facilities to verify compliance.
• Supply Chain Security: Measures are in place to prevent counterfeiting and ensure the integrity of the supply chain from raw materials to the patient.
• Post-Market Surveillance: Ongoing monitoring of product quality and safety once the drug is on the market.

Cosmo Pharmaceuticals, as the marketing authorization holder, is responsible for the overall quality and compliance of the WYNZORA supply chain, including the qualification and oversight of its API suppliers, excipient providers, and contract manufacturers.

Supply Chain Risks and Mitigation

Potential risks in the WYNZORA supply chain include API shortages, quality control failures at supplier sites, geopolitical instability affecting key manufacturing regions, and transportation disruptions.

Identified Risk Factors

• Single-Source API Reliance: Over-reliance on a single API manufacturer can create vulnerabilities if that supplier experiences production issues or faces regulatory actions.
• Geopolitical Concentration: A significant portion of API manufacturing is concentrated in specific regions (e.g., India, China). Trade disputes, natural disasters, or pandemics in these regions can impact global supply.
• Excipient Quality Variability: Inconsistent quality of excipients can affect the performance and stability of the final drug product.
• CMO Capacity Constraints: Demand fluctuations or unexpected issues at CMO facilities can lead to production delays.

Mitigation Strategies

• Dual Sourcing: Qualifying and maintaining relationships with multiple suppliers for critical APIs and excipients.
• Supply Chain Audits: Regular and thorough audits of all suppliers to ensure adherence to quality and regulatory standards.
• Inventory Management: Maintaining adequate safety stocks of critical raw materials and finished goods.
• Geographic Diversification: Sourcing from suppliers located in different geographical regions to mitigate country-specific risks.
• Contingency Planning: Developing robust contingency plans for supply chain disruptions, including alternative manufacturing sites and logistics partners.

Key Takeaways

• WYNZORA's API, diclofenac sodium, is sourced from global manufacturers, primarily in India and China, with European options available.
• The specialized gel vehicle requires pharmaceutical-grade excipients from established chemical and specialty ingredient providers.
• Contract manufacturing organizations (CMOs) with expertise in topical formulations and sterile filling likely play a role in WYNZORA's final production.
• Robust regulatory compliance (GMP) and supply chain oversight are critical for ensuring product quality and patient safety.
• Potential risks include API shortages and geographic concentration of manufacturing, necessitating dual sourcing and diversification strategies.

Frequently Asked Questions

1. Who is the primary manufacturer of WYNZORA's active pharmaceutical ingredient (API)? The API, diclofenac sodium, is sourced from multiple global manufacturers, including companies like Granules India Ltd., Dr. Reddy's Laboratories, Alkem Laboratories Ltd., and Sichuan Kelun Pharmaceutical Co., Ltd. Specific supplier selection is based on quality, cost, and regulatory compliance.

2. Does Cosmo Pharmaceuticals manufacture WYNZORA internally or use contract manufacturers? Cosmo Pharmaceuticals may utilize its own manufacturing facilities or engage contract manufacturing organizations (CMOs) with expertise in topical drug formulation and sterile filling. Companies like Catalent Pharma Solutions and Recipharm AB are examples of CMOs with relevant capabilities.

3. What are the key excipients used in WYNZORA, and who supplies them? While proprietary, the gel vehicle likely includes solvents (e.g., water, propylene glycol), gelling agents (e.g., carbomers), emulsifiers, and penetration enhancers. Suppliers for these materials typically include large chemical companies such as BASF SE, Dow Chemical Company, Croda International Plc, Evonik Industries AG, and Ashland Global Holdings Inc.

4. What are the primary regulatory bodies overseeing WYNZORA's manufacturing and supply chain? The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are the principal regulatory bodies overseeing the manufacturing, quality control, and supply chain of pharmaceuticals like WYNZORA, ensuring compliance with Good Manufacturing Practices (GMP).

5. What steps are taken to ensure the security and reliability of WYNZORA's supply chain? Supply chain reliability is managed through strategies such as qualifying multiple suppliers for critical raw materials (dual sourcing), conducting rigorous supplier audits, maintaining safety stock inventories, diversifying geographic sourcing to mitigate geopolitical risks, and developing contingency plans for potential disruptions.

Cited Sources

1. Granules India Ltd. (n.d.). Product List. Retrieved from [Company Website]
2. Dr. Reddy's Laboratories. (n.d.). API Products. Retrieved from [Company Website]
3. Alkem Laboratories Ltd. (n.d.). API Segment. Retrieved from [Company Website]
4. Sichuan Kelun Pharmaceutical Co., Ltd. (n.d.). Products. Retrieved from [Company Website]
5. Industrias Farmaceuticas Alco. (n.d.). Product Portfolio. Retrieved from [Company Website]
6. BASF SE. (n.d.). Pharmaceutical Excipients. Retrieved from [Company Website]
7. Croda International Plc. (n.d.). Life Sciences Solutions. Retrieved from [Company Website]
8. Evonik Industries AG. (n.d.). Pharma & Healthcare. Retrieved from [Company Website]
9. Ashland Global Holdings Inc. (n.d.). Pharmaceutical Excipients. Retrieved from [Company Website]
10. Catalent Pharma Solutions. (n.d.). Drug Delivery Technologies. Retrieved from [Company Website]
11. Recipharm AB. (n.d.). Services. Retrieved from [Company Website]