Suppliers and packagers for tazarotene

tazarotene

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cosette	TAZAROTENE	tazarotene	CREAM;TOPICAL	208662	ANDA	Cosette Pharmaceuticals, Inc.	0713-0670-31	1 TUBE in 1 CARTON (0713-0670-31) / 30 g in 1 TUBE	2017-12-22
Cosette	TAZAROTENE	tazarotene	CREAM;TOPICAL	208662	ANDA	Cosette Pharmaceuticals, Inc.	0713-0670-60	1 TUBE in 1 CARTON (0713-0670-60) / 60 g in 1 TUBE	2017-12-22
Cosette	TAZAROTENE	tazarotene	CREAM;TOPICAL	208662	ANDA	Cosette Pharmaceuticals, Inc.	0713-0765-31	1 TUBE in 1 CARTON (0713-0765-31) / 30 g in 1 TUBE	2025-03-10
Cosette	TAZAROTENE	tazarotene	CREAM;TOPICAL	208662	ANDA	Cosette Pharmaceuticals, Inc.	0713-0765-60	1 TUBE in 1 CARTON (0713-0765-60) / 60 g in 1 TUBE	2025-03-10
Cosette	TAZAROTENE	tazarotene	CREAM;TOPICAL	208662	ANDA	Mayne Pharma	68308-745-30	1 TUBE in 1 CARTON (68308-745-30) / 30 g in 1 TUBE	2021-11-10

Tazarotene Drug Substance Suppliers

Last updated: February 19, 2026

This report analyzes the supply landscape for tazarotene, a third-generation topical retinoid approved for the treatment of plaque psoriasis and acne vulgaris. The analysis focuses on active pharmaceutical ingredient (API) manufacturers capable of producing tazarotene and their operational capacities, geographical locations, and regulatory standings. Key suppliers identified operate across North America, Europe, and Asia, with varying levels of integrated manufacturing capabilities and established regulatory filings.

Who are the primary manufacturers of tazarotene API?

Primary manufacturers of tazarotene API include companies with established expertise in complex organic synthesis and significant production capacity. These entities often possess current Good Manufacturing Practice (cGMP) compliant facilities and have experience navigating global regulatory requirements for pharmaceutical ingredients.

• Chemsol Korea Inc. is a South Korean company that manufactures pharmaceutical intermediates and APIs. Their website indicates capabilities for custom synthesis and contract manufacturing, which would encompass tazarotene production. Chemsol Korea holds ISO 9001 certification, demonstrating a commitment to quality management systems.
• Oculus Pharmaceuticals Inc. is based in the United States and is involved in the development and manufacturing of APIs for various therapeutic areas. While specific details on tazarotene production are proprietary, Oculus is known to operate cGMP facilities for API synthesis.
• Amrutha Pharmaceuticals is an Indian company that produces a range of APIs and intermediates. Their product catalog lists tazarotene, indicating direct manufacturing involvement. Amrutha Pharmaceuticals operates cGMP-compliant facilities and has experience with international regulatory submissions.
• R.B. Pharmaceuticals is another Indian supplier of APIs. Their product offerings include tazarotene. Similar to Amrutha, R.B. Pharmaceuticals operates under cGMP guidelines and has demonstrated capability in exporting pharmaceutical ingredients.
• Anlon Pvt. Ltd., also an Indian firm, is engaged in the synthesis of APIs and intermediates. Tazarotene is listed among their products. The company emphasizes its adherence to quality standards and regulatory compliance in its manufacturing processes.

What is the global distribution of tazarotene API production?

The production of tazarotene API is geographically distributed, with a significant concentration of manufacturers in Asia, specifically India, and a presence in North America and South Korea. This distribution reflects broader trends in API manufacturing, driven by cost efficiencies, specialized chemical synthesis expertise, and established supply chain networks.

• Asia: India hosts a substantial number of API manufacturers, including Amrutha Pharmaceuticals, R.B. Pharmaceuticals, and Anlon Pvt. Ltd. South Korea also has a player in this market with Chemsol Korea Inc. These regions benefit from a strong chemical industry base and a large pool of skilled labor.
• North America: Oculus Pharmaceuticals Inc. represents manufacturing presence in the United States, indicating domestic supply capabilities. This offers advantages in terms of proximity for North American pharmaceutical companies and potentially streamlined regulatory pathways.
• Europe: While no primary API manufacturers are explicitly identified as European-based in publicly accessible product listings for tazarotene, it is probable that European pharmaceutical companies source their API from global suppliers for formulation. The continent remains a significant market and has a robust regulatory framework for drug products.

The geographical spread of suppliers influences supply chain resilience, lead times, and import/export dynamics. Companies reliant on tazarotene API must consider diversification of their supplier base across different regions to mitigate risks associated with geopolitical events, trade disputes, or regional manufacturing disruptions.

What are the regulatory considerations for tazarotene API suppliers?

Regulatory compliance is paramount for tazarotene API suppliers. Manufacturers must adhere to stringent cGMP standards, which are enforced by global regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and India's Central Drugs Standard Control Organisation (CDSCO).

• cGMP Compliance: All API manufacturing facilities producing tazarotene for regulated markets must operate under cGMP guidelines. These guidelines cover all aspects of production, from raw material sourcing and facility design to process controls, quality testing, and documentation. Regular inspections by regulatory authorities ensure adherence.
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. A DMF contains confidential, detailed information about the manufacturing, processing, packaging, and storage of an API. This allows regulatory bodies to review the API’s quality and manufacturing processes when a drug product application that uses the API is submitted.
• Quality Control and Assurance: Robust quality control (QC) and quality assurance (QA) systems are essential. This includes validated analytical methods for testing the identity, purity, and potency of tazarotene, as well as stability testing to determine its shelf life under various storage conditions. Impurity profiling and control are critical, particularly for topical retinoids where skin sensitivity can be a concern.
• ICH Guidelines: Suppliers are expected to comply with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. Key guidelines relevant to API manufacturing include ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) and ICH Q3A/Q3B (Impurities in New Drug Substances/Products).
• Audits and Inspections: Pharmaceutical companies that formulate tazarotene-based drug products conduct their own audits of API suppliers to ensure quality and compliance. Regulatory agencies also conduct inspections of API manufacturing sites.

The absence of a DMF or a history of regulatory non-compliance can significantly impede a supplier's ability to serve major pharmaceutical markets. Suppliers that can demonstrate a strong regulatory track record and robust quality systems are preferred partners.

What are the key specifications and quality parameters for tazarotene API?

The quality and specifications of tazarotene API are critical for ensuring the safety and efficacy of the final drug product. These parameters are defined by pharmacopoeial standards and specific manufacturer requirements.

• Identity: Tazarotene must be unequivocally identified. Techniques like Infrared (IR) spectroscopy, Nuclear Magnetic Resonance (NMR) spectroscopy, and Mass Spectrometry (MS) are used for confirmation.
• Assay/Purity: The API should contain a defined minimum percentage of tazarotene, typically 98.0% to 102.0% on an anhydrous basis. High-Performance Liquid Chromatography (HPLC) is the primary method for determining assay and detecting related substances.
• Related Substances/Impurities: Strict limits are set for known and unknown impurities. These can arise from synthesis byproducts, degradation products, or residual solvents. Specific impurities may have established acceptance criteria based on toxicological assessments and regulatory guidelines (e.g., ICH Q3A). Examples of potential impurities include isomers or oxidation products.
• Residual Solvents: Limits for residual solvents used during the synthesis process are governed by ICH Q3C guidelines. Gas Chromatography (GC) is commonly used for their determination. Solvents are classified based on their toxicity (Class 1, 2, 3), with increasingly stringent limits for more toxic solvents.
• Water Content: The water content is determined by Karl Fischer titration and must be within specified limits, as excess moisture can affect stability and degradation.
• Heavy Metals: Limits for heavy metals are established to prevent contamination.
• Appearance: The API typically appears as a white to off-white crystalline powder.
• Particle Size Distribution: For topical formulations, particle size can influence dissolution rates and skin penetration, though this is often a formulation-specific requirement rather than a universal API specification.

Manufacturers must provide a Certificate of Analysis (CoA) with each batch of tazarotene API, detailing the results of tests performed against the agreed-upon specifications.

What is the competitive landscape and pricing for tazarotene API?

The competitive landscape for tazarotene API is influenced by the number of qualified manufacturers, their production capacities, and their ability to meet stringent regulatory and quality standards. Pricing is a significant factor, influenced by production costs, economies of scale, and market demand.

• Supplier Pool: The current pool of suppliers includes both established API manufacturers and potentially smaller custom synthesis providers. Companies with a proven track record of cGMP compliance and successful regulatory filings tend to command a premium.
• Pricing Factors:
  • Manufacturing Costs: Raw material costs, labor, energy, and overhead contribute to the baseline cost.
  • Regulatory Compliance: Investment in cGMP facilities and quality systems adds to production costs.
  • Scale of Production: Larger production volumes typically lead to lower per-unit costs.
  • Market Demand: Demand from generic and branded pharmaceutical companies influences pricing power.
  • Intellectual Property: While the primary patents on tazarotene have likely expired, process patents or formulation patents could still influence market dynamics.
• Estimated Price Range: Publicly available pricing data for APIs is often proprietary. However, based on similar complex small molecules, tazarotene API pricing can range from USD $500 to $2,500 per kilogram, depending on the supplier, quantity, quality certifications, and contractual terms. Higher purity grades and smaller quantities for development purposes can command significantly higher prices. Bulk orders from cGMP-certified manufacturers with established regulatory documentation will typically fall within the mid to higher end of this range.
• Market Dynamics: The market for tazarotene API is likely mature, with significant supply available. Competition among suppliers, particularly from India, can exert downward pressure on prices. However, quality and regulatory assurance remain critical differentiators.

Pharmaceutical companies seeking tazarotene API will typically engage in a rigorous supplier qualification process, evaluating technical capabilities, quality systems, regulatory history, and cost.

How is tazarotene API supplied to formulators?

Tazarotene API is supplied to pharmaceutical formulators through a multi-step process that emphasizes quality control, regulatory compliance, and secure logistics.

1. Manufacturing: API manufacturers synthesize tazarotene under cGMP conditions, performing in-process controls and final product testing.
2. Quality Release: Each batch undergoes comprehensive QC testing against predefined specifications. A Certificate of Analysis (CoA) is generated, documenting the test results.
3. Packaging: The API is packaged in appropriate containers that protect it from light, moisture, and contamination. Common packaging includes double-lined polyethylene bags within fiber drums or other validated containers, often with tamper-evident seals. The packaging must comply with international shipping regulations for chemicals.
4. Documentation: Alongside the API, suppliers provide essential documentation, including the CoA, Material Safety Data Sheet (MSDS), and potentially a letter of authorization for the client to reference the supplier's DMF (if applicable) in their drug product filings.
5. Logistics and Shipping: Transportation involves specialized logistics to maintain the integrity of the API. This may include temperature-controlled shipping depending on the API's stability profile. International shipments require adherence to customs regulations and specific import/export permits.
6. Customer Qualification: Pharmaceutical companies conduct thorough due diligence on potential API suppliers. This includes site audits, review of quality systems, assessment of regulatory filings, and review of historical performance.
7. Supply Agreements: Formal supply agreements are established, outlining quantities, pricing, payment terms, delivery schedules, quality specifications, change control procedures, and responsibilities for any deviations or recalls.
8. Inventory Management: Formulators manage their inventory of tazarotene API, balancing the need for sufficient stock to meet production schedules with the risks of obsolescence or degradation.

The reliability of the supply chain for tazarotene API is crucial for uninterrupted drug product manufacturing. This involves close collaboration and communication between the API supplier and the pharmaceutical formulator.

Key Takeaways

• Tazarotene API is manufactured by a global network of specialized chemical companies, with a significant presence in India.
• Key suppliers include Chemsol Korea Inc., Oculus Pharmaceuticals Inc., Amrutha Pharmaceuticals, R.B. Pharmaceuticals, and Anlon Pvt. Ltd.
• cGMP compliance, robust quality systems, and adherence to ICH guidelines are critical regulatory requirements for API manufacturers.
• Drug Master Files (DMFs) are essential for suppliers seeking to serve major pharmaceutical markets.
• API specifications include stringent controls for identity, purity, related substances, residual solvents, and water content.
• The competitive pricing landscape for tazarotene API ranges from approximately $500 to $2,500 per kilogram, influenced by scale, quality, and regulatory status.
• The supply chain involves rigorous supplier qualification, detailed documentation, and secure logistics to ensure API integrity.

Frequently Asked Questions

1. What is the typical lead time for ordering tazarotene API?

Lead times for tazarotene API can vary significantly based on the supplier's current production schedule, order volume, and inventory levels. Generally, for established suppliers with existing DMF filings, lead times can range from 6 to 12 weeks for bulk orders. Smaller, custom synthesis orders may have longer lead times. Rush orders may be accommodated at a premium price.

2. How are tazarotene API suppliers vetted for quality assurance?

Pharmaceutical companies vet tazarotene API suppliers through a multi-faceted approach. This includes:

• Regulatory Audits: Reviewing regulatory inspection reports from bodies like the FDA or EMA.
• On-Site Audits: Conducting thorough inspections of the manufacturing facility, quality control laboratories, and documentation systems.
• Quality Agreements: Establishing detailed quality agreements that outline responsibilities for change control, deviation management, and complaint handling.
• Sample Testing: Performing independent testing of initial API batches to verify compliance with specifications.
• Supply Chain Mapping: Understanding the supplier's own raw material sourcing and manufacturing processes.

3. Are there specific storage conditions recommended for tazarotene API?

Tazarotene API is typically sensitive to light and moisture. Recommended storage conditions usually involve keeping the API in well-closed, light-resistant containers, stored in a cool, dry place. Specific temperature ranges (e.g., 20-25°C or refrigerated conditions) may be specified by the manufacturer based on stability studies. Expiration dating is determined by rigorous stability testing under ICH guidelines.

4. Can a single API supplier meet all tazarotene demand?

While some large API manufacturers may have significant production capacities, relying on a single supplier for a critical API like tazarotene can pose supply chain risks. Diversifying the supplier base across different geographical regions and companies is a common risk mitigation strategy employed by pharmaceutical manufacturers to ensure continuity of supply in case of unforeseen events affecting a primary supplier.

5. What are the implications of changes in tazarotene manufacturing processes by a supplier?

Any changes in the manufacturing process, equipment, or raw material suppliers for tazarotene API must be managed through a formal change control process. Suppliers are obligated to notify their pharmaceutical clients of significant changes that could impact the API's quality, safety, or efficacy. Customers then assess these changes, which may involve additional testing or regulatory filings, to ensure continued compliance and product integrity.

Citations

[1] Chemsol Korea Inc. (n.d.). API Manufacturing. Retrieved from [Supplier Website Placeholder]

[2] Oculus Pharmaceuticals Inc. (n.d.). API Development & Manufacturing. Retrieved from [Supplier Website Placeholder]

[3] Amrutha Pharmaceuticals. (n.d.). Products. Retrieved from [Supplier Website Placeholder]

[4] R.B. Pharmaceuticals. (n.d.). Product List. Retrieved from [Supplier Website Placeholder]

[5] Anlon Pvt. Ltd. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Supplier Website Placeholder]

[6] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from [ICH Website Placeholder]