Suppliers and packagers for ENTACAPONE

ENTACAPONE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ajanta Pharma Ltd	ENTACAPONE	entacapone	TABLET;ORAL	205792	ANDA	Ajanta Pharma USA Inc.	27241-049-10	100 TABLET in 1 BOTTLE (27241-049-10)	2017-08-31
Alembic	ENTACAPONE	entacapone	TABLET;ORAL	212601	ANDA	Alembic Pharmaceuticals Limited	46708-478-31	100 TABLET, FILM COATED in 1 BOTTLE (46708-478-31)	2022-01-06
Alembic	ENTACAPONE	entacapone	TABLET;ORAL	212601	ANDA	Alembic Pharmaceuticals Limited	46708-478-91	1000 TABLET, FILM COATED in 1 BOTTLE (46708-478-91)	2022-01-06
Alembic	ENTACAPONE	entacapone	TABLET;ORAL	212601	ANDA	Alembic Pharmaceuticals Inc.	62332-478-31	100 TABLET, FILM COATED in 1 BOTTLE (62332-478-31)	2022-01-06
Alembic	ENTACAPONE	entacapone	TABLET;ORAL	212601	ANDA	Alembic Pharmaceuticals Inc.	62332-478-91	1000 TABLET, FILM COATED in 1 BOTTLE (62332-478-91)	2022-01-06
Aurobindo Pharma Ltd	ENTACAPONE	entacapone	TABLET;ORAL	203437	ANDA	Major Pharmaceuticals	0904-6822-07	30 BLISTER PACK in 1 CARTON (0904-6822-07) / 1 TABLET, FILM COATED in 1 BLISTER PACK	2015-06-19
Aurobindo Pharma Ltd	ENTACAPONE	entacapone	TABLET;ORAL	203437	ANDA	AvPAK	50268-295-15	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-295-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-295-11)	2016-12-05

Entacapone Supplier Landscape Analysis

Last updated: February 19, 2026

This report analyzes the global supplier landscape for Entacapone, a catechol-O-methyltransferase (COMT) inhibitor used in Parkinson's disease treatment. The analysis focuses on key manufacturers, their production capabilities, regulatory standing, and market positioning, providing insights for pharmaceutical companies and investors.

Who are the Primary Manufacturers of Entacapone Active Pharmaceutical Ingredient (API)?

The global supply of Entacapone API is concentrated among a limited number of manufacturers, primarily located in India and China. These suppliers have established production facilities and possess the necessary regulatory approvals to serve the global pharmaceutical market.

Key Entacapone API Manufacturers:

• Orchid Pharma Ltd.: Based in India, Orchid Pharma is a significant player in the API manufacturing sector. The company has a history of producing various complex APIs.
  • Manufacturing Sites: Multiple FDA-inspected facilities in India [1].
  • Regulatory Approvals: US FDA, EDQM, COFEPRIS, KFDA, and other international regulatory bodies.
  • Market Focus: Global supply to generic and innovator pharmaceutical companies.
• Laurus Labs Limited: Another prominent Indian API manufacturer, Laurus Labs, has expanded its portfolio to include a range of therapeutic areas.
  • Manufacturing Sites: State-of-the-art facilities in India compliant with international standards.
  • Regulatory Approvals: US FDA, EMA, PMDA (Japan), and others.
  • Market Focus: Serves a broad spectrum of pharmaceutical clients worldwide.
• Zhejiang NHU Co., Ltd.: A major Chinese chemical and pharmaceutical company, NHU has a substantial API manufacturing operation.
  • Manufacturing Sites: Large-scale production facilities in China.
  • Regulatory Approvals: Holds certifications from various international regulatory authorities.
  • Market Focus: Significant exporter of APIs to regulated and semi-regulated markets.
• Sun Pharmaceutical Industries Ltd.: While primarily known as a finished dosage form manufacturer, Sun Pharma also produces select APIs, including those for its own formulations and for external sales.
  • Manufacturing Sites: Multiple API manufacturing sites across India.
  • Regulatory Approvals: US FDA, EMA, and other key agencies.
  • Market Focus: Internal supply and strategic external partnerships for API sales.
• Divi's Laboratories Limited: A leading manufacturer of APIs and intermediates, Divi's is recognized for its capacity and quality.
  • Manufacturing Sites: Large, multi-site API manufacturing facilities in India.
  • Regulatory Approvals: US FDA, EMA, and others.
  • Market Focus: Supplies to major global pharmaceutical companies.

These manufacturers are characterized by their integrated manufacturing processes, adherence to Good Manufacturing Practices (GMP), and established quality control systems. Their ability to scale production and maintain consistent quality is crucial for meeting global demand for Entacapone.

What are the Regulatory Considerations for Entacapone API Suppliers?

Regulatory compliance is paramount for Entacapone API suppliers. Manufacturers must adhere to stringent guidelines set forth by major health authorities to ensure the safety, efficacy, and quality of the API.

Key Regulatory Requirements and Bodies:

• US Food and Drug Administration (FDA): Requires rigorous adherence to Current Good Manufacturing Practices (cGMP). Site inspections and Drug Master File (DMF) submissions are essential for market access in the United States [2].
• European Medicines Agency (EMA) & European Directorate for the Quality of Medicines & HealthCare (EDQM): Compliance with European Pharmacopoeia (Ph. Eur.) standards and issuance of Certificates of Suitability (CEP) by EDQM are critical for supplying to the European Union [3].
• Other National Regulatory Agencies: Authorities such as Japan's Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, and China's National Medical Products Administration (NMPA) have their own specific requirements, often involving on-site inspections and detailed documentation.
• ICH Guidelines: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, particularly those related to quality (Q series), are globally adopted standards for API manufacturing and control.
• Impurity Profiling and Control: Manufacturers must demonstrate robust control over impurities, including genotoxic impurities, as per ICH M7 guidelines. This involves detailed analytical method development and validation.
• Supply Chain Integrity: Ensuring the integrity of the entire supply chain, from raw material sourcing to final API delivery, is a regulatory expectation. This includes robust vendor qualification programs and secure logistics.

Suppliers with a strong regulatory track record, including successful FDA and EMA inspections, and readily available DMFs or CEPs, are generally preferred by pharmaceutical companies seeking to expedite their drug product approvals.

How do Entacapone API Suppliers Differentiate Themselves in the Market?

Differentiation in the Entacapone API market is driven by several factors, including pricing, quality, regulatory support, supply chain reliability, and innovation.

Differentiation Strategies:

• Cost Leadership: Companies with efficient manufacturing processes, economies of scale, and favorable raw material sourcing can offer competitive pricing. This is particularly relevant for generic drug manufacturers.
• Quality and Regulatory Excellence: Suppliers with a proven history of regulatory compliance, consistently high API quality, and comprehensive regulatory support documentation (e.g., robust DMFs, successful audit histories) command a premium.
• Supply Chain Security and Reliability: Ensuring uninterrupted supply through diversified raw material sourcing, redundant manufacturing capabilities, and robust inventory management is a significant differentiator.
• Technical Support and Customization: Offering advanced technical support, including assistance with formulation development, impurity troubleshooting, and tailored particle size distribution, adds value.
• Intellectual Property (IP) Navigation: For innovator companies, securing API supply from manufacturers who have navigated and respect patent landscapes is critical. For generic companies, identifying suppliers capable of providing non-infringing routes or materials for Paragraph IV filings is key.
• Sustainability and Environmental Practices: Growing emphasis on green chemistry and sustainable manufacturing practices can be a differentiating factor, particularly for companies with strong Environmental, Social, and Governance (ESG) commitments.

The competitive landscape is dynamic, with established players continuously optimizing their operations and new entrants seeking market penetration.

What is the Production Capacity and Scale for Entacapone API?

The production capacity for Entacapone API is substantial, driven by the global demand for Parkinson's disease treatments. Key manufacturers possess large-scale synthesis capabilities to meet market needs.

Estimates of Production Capacity:

While precise public figures for specific API production volumes are rarely disclosed, industry estimates suggest that the aggregate global capacity for Entacapone API can support current and projected market demand for both innovator and generic products.

• Indian Manufacturers: Companies like Orchid Pharma, Laurus Labs, and Divi's Laboratories have multi-tonnage per annum manufacturing capabilities for various APIs, and Entacapone production is likely within this range for those specializing in its synthesis.
• Chinese Manufacturers: Zhejiang NHU operates large-scale chemical synthesis plants, enabling significant output.
• Scale of Operations: Production often occurs in multi-purpose reaction vessels ranging from 1,000 to 10,000 liters, allowing for flexible batch sizes and high throughput.
• Process Optimization: Continuous process improvement and investment in new technologies, such as continuous flow chemistry, can further enhance efficiency and output.

The ability to scale production up or down based on market demand is a critical operational advantage for Entacapone API suppliers.

What is the Patent Landscape Affecting Entacapone API Suppliers?

The patent landscape for Entacapone is complex, involving patents on the compound itself, its polymorphic forms, methods of synthesis, and specific therapeutic uses. Suppliers must navigate this landscape to avoid infringement.

Key Patent Considerations:

• Composition of Matter Patent: The original patent for Entacapone has long expired in major markets, opening the door for generic competition.
• Polymorphic Forms: Patents covering specific crystalline forms of Entacapone (e.g., Form A, Form B) can extend market exclusivity. Manufacturers must ensure their synthesis processes do not yield infringing polymorphs.
• Process Patents: Novel or improved synthetic routes to Entacapone may be patented. API suppliers often develop non-infringing synthetic pathways or license patented processes.
• Formulation Patents: While not directly related to API supply, patents on specific drug product formulations (e.g., immediate-release, controlled-release, fixed-dose combinations with Levodopa/Carbidopa) can influence the demand for Entacapone API and the choice of suppliers by generic companies aiming for market entry post-patent expiry of the final product.
• Exclusivity Periods: Understanding the expiration dates of all relevant patents and regulatory exclusivities (e.g., New Chemical Entity (NCE) exclusivity, pediatric exclusivity) in key markets is crucial for market entry strategies for API suppliers and their pharmaceutical clients.

API suppliers often conduct their own freedom-to-operate (FTO) analyses to ensure their manufacturing processes and products do not infringe on existing patents.

Who are the Key Suppliers of Entacapone Finished Dosage Forms?

While this analysis focuses on API suppliers, understanding the finished dosage form (FDF) market is essential as it dictates API demand. The primary FDF product containing Entacapone is Comtan® (Novartis AG) and its generic equivalents, often in combination with Levodopa and Carbidopa (e.g., Stalevo®).

Major FDF Players:

• Novartis AG: The innovator company for Comtan®.
• Generic Manufacturers: Numerous global generic companies, including:
  • Teva Pharmaceutical Industries Ltd.
  • Mylan N.V. (now Viatris Inc.)
  • Sun Pharmaceutical Industries Ltd.
  • Dr. Reddy's Laboratories Ltd.
  • Torrent Pharmaceuticals Ltd.

These FDF manufacturers are the direct customers for Entacapone API suppliers. Their product portfolios, market penetration, and regulatory approval status significantly influence API procurement decisions.

Key Takeaways

The Entacapone API market is characterized by a focused group of experienced manufacturers, primarily in India and China, possessing significant production capacity and adhering to stringent global regulatory standards. Differentiation among suppliers hinges on a combination of competitive pricing, uncompromising quality, robust regulatory support, and supply chain reliability. The patent landscape, while largely open for the compound itself, still presents considerations regarding specific polymorphic forms and synthetic processes, necessitating careful navigation by API manufacturers. The demand for Entacapone API is directly tied to the robust global market for Parkinson's disease therapeutics, including both monotherapy and combination products.

Frequently Asked Questions

1. What are the typical lead times for Entacapone API orders? Lead times can vary but generally range from 8 to 16 weeks, depending on the supplier's current production schedule, order volume, and any specific quality requirements or customization needs.

2. Are there any known supply chain vulnerabilities for Entacapone API? Potential vulnerabilities include dependence on specific raw material suppliers, geopolitical risks affecting key manufacturing regions, and disruptions due to unforeseen regulatory changes or quality issues. Diversification of suppliers and geographic sourcing can mitigate these risks.

3. What is the impact of emerging markets on Entacapone API demand? Emerging markets, as they expand access to healthcare and diagnostic capabilities for neurological disorders, are expected to contribute to increased demand for Entacapone API, alongside established markets.

4. How do API suppliers ensure consistency in Entacapone quality across batches? Consistency is achieved through strict adherence to cGMP, comprehensive in-process controls, validated analytical methods for raw materials and finished API, robust quality management systems, and regular internal and external audits.

5. What are the key quality attributes that pharmaceutical companies scrutinize in Entacapone API? Pharmaceutical companies critically assess purity (e.g., assay, related substances, residual solvents), physical characteristics (e.g., particle size distribution, polymorphic form), microbial limits, and stability data.

Citations

[1] Orchid Pharma Ltd. (n.d.). API Manufacturing Facilities. Retrieved from Orchid Pharma's official website (specific URL not provided, general company information used).

[2] U.S. Food and Drug Administration. (n.d.). Inspections, Compliance, Enforcement, and Criminal Investigations. Retrieved from FDA website.

[3] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificates of Suitability. Retrieved from EDQM website.