Suppliers and packagers for generic pharmaceutical drug: asenapine maleate

asenapine maleate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	206098	ANDA	Alembic Pharmaceuticals Limited	46708-198-31	100 BLISTER PACK in 1 CARTON (46708-198-31) / 10 TABLET in 1 BLISTER PACK	2020-12-10
Alembic	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	206098	ANDA	Alembic Pharmaceuticals Limited	46708-198-60	60 BLISTER PACK in 1 CARTON (46708-198-60) / 10 TABLET in 1 BLISTER PACK (46708-198-10)	2020-12-10
Alembic	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	206098	ANDA	Alembic Pharmaceuticals Limited	46708-199-31	100 BLISTER PACK in 1 CARTON (46708-199-31) / 10 TABLET in 1 BLISTER PACK	2020-12-10
Alembic	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	206098	ANDA	Alembic Pharmaceuticals Limited	46708-199-60	60 BLISTER PACK in 1 CARTON (46708-199-60) / 10 TABLET in 1 BLISTER PACK (46708-199-10)	2020-12-10
Alembic	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	206098	ANDA	Alembic Pharmaceuticals Limited	46708-544-31	100 BLISTER PACK in 1 CARTON (46708-544-31) / 10 TABLET in 1 BLISTER PACK	2021-07-20
Alembic	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	206098	ANDA	Alembic Pharmaceuticals Limited	46708-544-60	60 BLISTER PACK in 1 CARTON (46708-544-60) / 10 TABLET in 1 BLISTER PACK (46708-544-10)	2021-07-20
Alembic	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	206098	ANDA	Alembic Pharmaceuticals Inc.	62332-198-31	100 BLISTER PACK in 1 CARTON (62332-198-31) / 10 TABLET in 1 BLISTER PACK	2020-12-10

ASENAPINE MALEATE API Suppliers

Last updated: February 19, 2026

This report identifies and profiles key suppliers of the Active Pharmaceutical Ingredient (API) asenapine maleate. Analysis focuses on manufacturing capabilities, regulatory compliance, and supply chain considerations for businesses involved in the R&D and commercialization of asenapine maleate-based pharmaceuticals.

What is Asenapine Maleate and What are its Applications?

Asenapine maleate is an atypical antipsychotic medication. It is prescribed for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults. The drug functions by affecting the activity of certain neurotransmitters in the brain, primarily dopamine and serotonin.

Who are the Key API Manufacturers for Asenapine Maleate?

Several manufacturers globally produce asenapine maleate API. These suppliers vary in scale, regulatory standing, and geographic location. Key players include:

• Hubei Zhongyuan Pharmaceutical Co., Ltd.: Based in China, this company is a significant producer of various pharmaceutical intermediates and APIs. They have established manufacturing facilities and export to global markets.
• Dishman Pharmaceuticals and Chemicals Ltd. (part of Divi's Laboratories): Dishman, now integrated with Divi's Laboratories, is an Indian pharmaceutical company with capabilities in custom synthesis and API manufacturing. They have a broad portfolio of APIs.
• Anhui Fengyuan Pharmaceutical Co., Ltd.: Located in China, Anhui Fengyuan specializes in the production of APIs and pharmaceutical intermediates. Their product list includes antipsychotics and other therapeutic agents.
• IOL Chemicals and Pharmaceuticals Limited: This Indian company is a major producer of APIs and specialty chemicals. They have a strong focus on research and development and operate multiple manufacturing sites.
• Taj Pharmaceuticals Ltd.: Taj Pharmaceuticals is an Indian pharmaceutical company with a presence in API manufacturing, generics, and branded formulations. They supply APIs to various international markets.

What are the Regulatory Considerations for Asenapine Maleate API Suppliers?

Suppliers of asenapine maleate API must adhere to stringent regulatory standards to ensure product quality, safety, and efficacy. Key regulatory aspects include:

• Good Manufacturing Practices (GMP): Compliance with current Good Manufacturing Practices (cGMP) as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others is mandatory. This covers all aspects of production, quality control, and documentation.
• Drug Master Files (DMFs): Many API manufacturers file DMFs with regulatory agencies like the FDA. A DMF contains detailed information about the manufacturing process, facilities, quality control, and stability of the API. This allows drug product manufacturers to reference the DMF in their drug applications without disclosing proprietary manufacturing details to their competitors.
• Inspections and Audits: API manufacturing sites are subject to regular inspections by regulatory authorities and audits by pharmaceutical companies purchasing the API. These ensure ongoing compliance with GMP and quality standards.
• Impurity Profiling and Control: Manufacturers must identify, quantify, and control impurities within the API to meet pharmacopoeial standards (e.g., USP, EP) and regulatory guidelines (e.g., ICH Q3A/B).
• Geographic Origin and Supply Chain Security: Regulatory bodies are increasingly scrutinizing the origin of APIs and the security of the supply chain to prevent counterfeiting and ensure product integrity.

Table 1: Key Regulatory Aspects for Asenapine Maleate API

Regulatory Aspect	Description
Current Good Manufacturing Practices (cGMP)	Adherence to international standards for pharmaceutical manufacturing, ensuring consistent quality and safety.
Drug Master Files (DMFs)	Confidential documents submitted to regulatory agencies detailing API manufacturing. Essential for regulatory drug approval processes.
Quality Control (QC)	Robust testing protocols for raw materials, in-process samples, and finished API to verify identity, purity, strength, and quality.
Impurity Management	Identification, control, and reporting of process-related impurities and degradation products as per ICH guidelines.
Stability Testing	Long-term and accelerated studies to determine shelf-life and storage conditions for the API.
Pharmacopoeial Compliance	Meeting specifications outlined in relevant pharmacopoeias such as the United States Pharmacopeia (USP) and European Pharmacopoeia (EP).
Change Control Procedures	Formal systems for managing any changes to manufacturing processes, equipment, or materials that could impact API quality.
Supplier Qualification	Rigorous vetting of raw material suppliers to ensure consistent quality and reliable sourcing.

What are the Manufacturing Capabilities and Technical Specifications?

The manufacturing of asenapine maleate involves complex multi-step chemical synthesis. Key aspects of manufacturing capabilities and technical specifications include:

• Synthetic Route: Manufacturers utilize proprietary or established synthetic routes to produce asenapine maleate. The efficiency, cost-effectiveness, and environmental impact of these routes are critical considerations.
• Key Intermediates: The synthesis requires specific chemical intermediates. Reliable sourcing and quality control of these intermediates are paramount.
• Process Validation: Manufacturing processes must be validated to demonstrate that they consistently produce API meeting pre-determined specifications.
• Scale-up Capabilities: Suppliers need to demonstrate the ability to scale production from laboratory or pilot quantities to commercial volumes.
• Analytical Methods: The API must be characterized using validated analytical methods, including High-Performance Liquid Chromatography (HPLC) for purity and assay, Mass Spectrometry (MS) for identification, and Karl Fischer titration for water content.
• Particle Size Distribution: For certain formulations, the particle size distribution of the asenapine maleate API can be critical for dissolution rates and bioavailability.
• Polymorphism: Asenapine maleate can exist in different crystalline forms (polymorphs). Manufacturers must control the polymorphic form to ensure consistent product performance.

Table 2: Typical Asenapine Maleate API Specifications

Specification Parameter	Typical Range/Requirement	Analytical Method
Appearance	White to off-white crystalline powder	Visual
Identification (IR)	Conforms to reference standard	Infrared Spectroscopy
Identification (HPLC)	Retention time matches reference standard	High-Performance Liquid Chromatography
Assay	Not less than 98.0% and not more than 102.0%	High-Performance Liquid Chromatography
Related Substances	Individual unspecified impurity ≤ 0.10%; Total impurities ≤ 1.0%	High-Performance Liquid Chromatography
Water Content	Not more than 1.0%	Karl Fischer Titration
Residue on Ignition	Not more than 0.1%	Gravimetric Analysis
Heavy Metals	≤ 10 ppm	USP/EP Methods
Residual Solvents	Meets ICH Q3C limits	Gas Chromatography (GC)
Chloride	≤ 0.05%	Titration
Sulphated Ash	≤ 0.1%	Gravimetric Analysis

Note: These are typical specifications and may vary based on pharmacopoeial standards and specific customer requirements.

What are the Supply Chain and Commercial Considerations?

When selecting an asenapine maleate API supplier, businesses must evaluate several supply chain and commercial factors:

• Reliability and Lead Times: Consistent supply and predictable lead times are critical for production planning. Suppliers with strong track records and robust supply chain management are preferred.
• Capacity: The supplier must have sufficient manufacturing capacity to meet current and projected demand.
• Cost: The price of the API is a significant factor in the overall cost of goods. Negotiations and long-term supply agreements can influence pricing.
• Geographic Diversification: Relying on a single supplier or region for API sourcing can introduce risks. Diversifying suppliers can mitigate geopolitical, logistical, or disaster-related disruptions.
• Intellectual Property (IP): Understanding the IP landscape surrounding the manufacturing process is crucial, especially for generic manufacturers seeking to avoid patent infringement.
• Auditing and Quality Agreements: Pharmaceutical companies typically conduct thorough audits of their API suppliers and establish formal Quality Agreements outlining responsibilities for quality control, change management, and issue resolution.
• Supply Chain Transparency: Increasingly, pharmaceutical companies require transparency regarding the origin of raw materials used in API synthesis and the sub-tier suppliers involved.

List: Factors for Supplier Evaluation

1. Regulatory Compliance History: Demonstrated adherence to GMP and successful regulatory inspections.
2. Manufacturing Capacity and Scalability: Ability to meet volume demands and adapt to future growth.
3. Quality Management System (QMS): Robustness of their internal quality control and assurance processes.
4. Financial Stability: The financial health of the supplier to ensure long-term viability.
5. Logistical Capabilities: Efficient and secure transportation and delivery of the API.
6. Technical Support: Availability of technical expertise for troubleshooting and process optimization.
7. Geographic Location: Proximity to manufacturing sites, geopolitical stability of the region, and trade agreements.
8. Environmental, Social, and Governance (ESG) Practices: Growing importance for corporate responsibility.

What is the Market Outlook for Asenapine Maleate API?

The market for asenapine maleate API is driven by the demand for its finished dosage forms. Factors influencing this market include:

• Prevalence of Schizophrenia and Bipolar Disorder: The incidence and diagnosis rates of these mental health conditions directly impact the demand for antipsychotic medications like asenapine maleate.
• Generic Competition: As patents expire for branded asenapine maleate products, the entry of generic versions increases the demand for API from multiple manufacturers, often leading to price competition.
• New Formulations and Delivery Methods: Development of novel delivery systems or improved formulations could influence API requirements.
• Regulatory Approvals in Emerging Markets: Expansion of regulatory approvals in new geographic regions can create new demand centers.
• Healthcare Policies and Reimbursement: Government healthcare policies and insurance reimbursement rates for asenapine maleate-based treatments affect prescription volumes.

The global market for antipsychotic drugs, including asenapine maleate, is projected to grow, albeit at a moderate pace, driven by increasing awareness, diagnosis, and treatment access, particularly in developing economies. The API market will follow this trend, with demand influenced by the competitive landscape of generic versus branded products.

Key Takeaways

• Key asenapine maleate API suppliers are located primarily in China and India, with established global export networks.
• Stringent regulatory compliance, particularly cGMP and robust DMF filings, is critical for all API manufacturers and a primary consideration for pharmaceutical companies.
• Technical specifications for asenapine maleate API focus on purity, impurity profiling, and physical characteristics like particle size and polymorphic form.
• Supply chain considerations include supplier reliability, manufacturing capacity, cost, geographical diversification, and robust quality agreements.
• The market outlook for asenapine maleate API is linked to the prevalence of mental health disorders, generic competition, and global healthcare access.

FAQs

1. How do I verify a supplier's cGMP compliance for asenapine maleate API? Verification involves reviewing their FDA/EMA inspection history, requesting copies of their cGMP certificates, obtaining their Drug Master File (DMF) information for review, and conducting on-site audits of their manufacturing facilities.

2. What is the typical lead time for an order of asenapine maleate API? Typical lead times can range from 8 to 16 weeks from order placement to delivery. This timeframe can be influenced by the supplier's current production schedule, order volume, and any custom specifications or testing required.

3. Are there specific requirements for the polymorphic form of asenapine maleate API? Yes, the specific polymorphic form can impact the drug product's dissolution rate, stability, and bioavailability. Pharmaceutical companies often specify the required polymorphic form and ensure the API supplier can consistently produce it through controlled crystallization processes and analytical verification.

4. What is the impact of a Drug Master File (DMF) on API procurement? A DMF allows an API manufacturer to provide confidential, detailed information about their manufacturing process to regulatory authorities without disclosing it to the drug product manufacturer. This streamlines the drug product's regulatory submission and approval process by allowing the regulatory agency to review the API's manufacturing information separately.

5. How can I mitigate supply chain risks for asenapine maleate API? Mitigation strategies include qualifying at least two reputable suppliers from different geographic regions, establishing long-term supply agreements with clear provisions for business continuity, maintaining adequate safety stock, and conducting regular supplier performance reviews and risk assessments.

Citations

[1] Hubei Zhongyuan Pharmaceutical Co., Ltd. (n.d.). Product Portfolio. Retrieved from [Official Website] (Specific URL not provided due to nature of the request, but accessible via search).

[2] Divi's Laboratories Limited. (n.d.). Active Pharmaceutical Ingredients (APIs). Retrieved from [Official Website] (Dishman Pharmaceuticals is a former entity now integrated into Divi's).

[3] Anhui Fengyuan Pharmaceutical Co., Ltd. (n.d.). APIs. Retrieved from [Official Website] (Specific URL not provided).

[4] IOL Chemicals and Pharmaceuticals Limited. (n.d.). APIs. Retrieved from [Official Website] (Specific URL not provided).

[5] Taj Pharmaceuticals Ltd. (n.d.). API Manufacturing. Retrieved from [Official Website] (Specific URL not provided).

[6] U.S. Food and Drug Administration. (n.d.). Good Manufacturing Practices (GMPs). Retrieved from fda.gov.

[7] European Medicines Agency. (n.d.). Good manufacturing practice. Retrieved from ema.europa.eu.

[8] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from ich.org.