Suppliers and packagers for generic pharmaceutical drug: CARBINOXAMINE MALEATE

CARBINOXAMINE 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
Genus	CARBINOXAMINE MALEATE	carbinoxamine maleate	SOLUTION;ORAL	040458	ANDA	Genus Lifesciences Inc.	64950-243-04	118 mL in 1 BOTTLE, PLASTIC (64950-243-04)	2023-06-09
Genus	CARBINOXAMINE MALEATE	carbinoxamine maleate	SOLUTION;ORAL	040458	ANDA	Genus Lifesciences Inc.	64950-243-16	473 mL in 1 BOTTLE, PLASTIC (64950-243-16)	2023-06-09
Genus	CARBINOXAMINE MALEATE	carbinoxamine maleate	SOLUTION;ORAL	040458	ANDA	IPG Pharmaceuticals, inc.	71085-080-07	473 mL in 1 BOTTLE, PLASTIC (71085-080-07)	2025-06-01
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556	NDA	Aytu Therapeutics, LLC	23594-101-01	2 BOTTLE, PLASTIC in 1 CARTON (23594-101-01) / 30 mL in 1 BOTTLE, PLASTIC	2014-01-03
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556	NDA	Aytu Therapeutics, LLC	23594-101-05	480 mL in 1 BOTTLE, PLASTIC (23594-101-05)	2014-01-03
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556	NDA AUTHORIZED GENERIC	Neos Therapeutics, LP	62542-101-05	480 mL in 1 BOTTLE, PLASTIC (62542-101-05)	2024-06-01
Genus	CARBINOXAMINE MALEATE	carbinoxamine maleate	TABLET;ORAL	040442	ANDA	Genus Lifesciences Inc.	64950-211-01	100 TABLET in 1 BOTTLE, PLASTIC (64950-211-01)	2023-08-02

Carbimoxamine Maleate: Active Pharmaceutical Ingredient Supplier Landscape

Last updated: February 19, 2026

Carbinoxamine maleate is an antihistamine primarily used in combination products for the symptomatic relief of cold and allergy symptoms. The global supply chain for its active pharmaceutical ingredient (API) is characterized by a concentrated manufacturing base, primarily in India and China, with limited diversification among key suppliers. Regulatory scrutiny, patent expiration, and evolving market demand influence supplier selection and sourcing strategies for pharmaceutical formulators.

Who are the Primary API Manufacturers for Carbinoxamine Maleate?

The manufacturing of carbinoxamine maleate API is concentrated among a few key global players. These suppliers are located predominantly in India and China, reflecting the broader trend of API production shifting to these regions due to cost efficiencies and established manufacturing infrastructure.

• AnsuRPharma (India): AnsuRPharma is a significant manufacturer of carbinoxamine maleate API. The company operates under Good Manufacturing Practices (GMP) and supplies to various international markets. Its production capacity and quality certifications are key factors for formulators.
• Spectrum Chemicals (USA): While primarily a distributor, Spectrum Chemicals sources and supplies pharmaceutical-grade carbinoxamine maleate. Their role often involves ensuring quality and compliance for a diverse customer base, including smaller formulators. They are a US-based supplier, offering an alternative to offshore manufacturing.
• Xinfa Pharmaceutical Co., Ltd. (China): Xinfa Pharmaceutical is a Chinese manufacturer of various APIs, including antihistamines. Their involvement in the carbinoxamine maleate market contributes to the global supply pool, offering competitive pricing. Compliance with international regulatory standards is crucial for their product acceptance.
• Parchem fine & specialty chemicals (USA): Similar to Spectrum Chemicals, Parchem functions as a distributor and supplier of carbinoxamine maleate. They leverage their global network to source APIs and provide them to pharmaceutical companies, emphasizing quality assurance and reliable delivery.
• Aarti Drugs Limited (India): Aarti Drugs is a prominent Indian API manufacturer with a diverse product portfolio. They produce carbinoxamine maleate, adhering to strict quality controls and regulatory requirements for both domestic and export markets.

The market share among these manufacturers can fluctuate based on production volume, pricing, and regulatory approvals in target markets. Companies often qualify multiple suppliers to mitigate supply chain risks.

What are the Key Regulatory Considerations for Carbinoxamine Maleate API Sourcing?

Sourcing carbinoxamine maleate API involves navigating a complex regulatory landscape. Pharmaceutical companies must ensure that their API suppliers meet stringent quality and compliance standards mandated by health authorities worldwide.

• Good Manufacturing Practices (GMP): All API manufacturers must adhere to current GMP standards established by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others. GMP compliance ensures product consistency, quality, and safety. Manufacturers typically hold GMP certifications from recognized authorities.
• Drug Master Files (DMFs): API suppliers often submit DMFs to regulatory agencies. A DMF provides detailed information about the manufacturing process, facilities, quality control, and stability of the API. This allows formulators to reference the DMF in their drug product applications without disclosing proprietary manufacturing details.
  • US FDA DMF: Open for inspection by the FDA.
  • European EDQM CEP: Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) indicates compliance with European Pharmacopoeia standards.
• Pharmacopoeial Standards: Carbinoxamine maleate API must meet specifications outlined in relevant pharmacopoeias, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP). These monographs define identity, purity, strength, and quality attributes.
• Inspections and Audits: Pharmaceutical formulators conduct regular audits of their API suppliers to verify GMP compliance and quality systems. Regulatory agencies also conduct site inspections of API manufacturing facilities.
• Country-Specific Regulations: Beyond GMP and pharmacopoeial standards, specific countries may have additional registration and import requirements for APIs. Formulators must be aware of these to ensure market access.

Failure to comply with these regulations can lead to significant delays in drug approval, product recalls, and reputational damage. Therefore, rigorous supplier qualification and ongoing monitoring are essential.

What is the Patent Landscape for Carbinoxamine Maleate?

Carbinoxamine maleate itself is a well-established drug, meaning the primary patents covering the compound itself have long expired. The patent landscape primarily focuses on new formulations, delivery methods, or combination therapies that may incorporate carbinoxamine maleate.

• Composition of Matter Patents: The original patents for carbinoxamine maleate, a first-generation H1 antagonist, expired decades ago. These patents would have covered the chemical entity and its basic therapeutic uses.
• Formulation Patents: Innovation in the carbinoxamine maleate space has historically focused on improved formulations to enhance efficacy, reduce side effects, or improve patient compliance. Examples include:
  • Extended-release formulations.
  • Novel combination products with other active ingredients for multi-symptom relief.
  • Specific excipient combinations to improve stability or bioavailability. These formulation patents can offer market exclusivity for a limited period.
• Method of Use Patents: While less common for older drugs, new therapeutic uses for carbinoxamine maleate could theoretically be patented if a novel indication is discovered and proven.
• Combination Therapy Patents: Many carbinoxamine maleate products are sold in combination with other APIs, such as decongestants (e.g., pseudoephedrine, phenylephrine) or other antihistamines. Patents may exist for these specific combinations and their therapeutic applications.
• Process Patents: There is a possibility of patents covering novel or significantly improved methods of synthesizing carbinoxamine maleate API, although these are less common for mature products where established manufacturing processes are cost-effective.

For companies developing new carbinoxamine maleate-containing products, a thorough patent search is critical to ensure freedom to operate and to identify potential licensing opportunities or infringement risks. The absence of primary compound patents means competition is largely driven by formulation innovation, cost of goods, and regulatory compliance.

What are the Key Market Dynamics and Trends Affecting Carbinoxamine Maleate API Supply?

The market for carbinoxamine maleate API is influenced by several factors, including the demand for over-the-counter (OTC) cold and allergy medications, generic competition, and global supply chain resilience.

• Demand for Cold and Allergy Medications: The primary driver for carbinoxamine maleate demand is the global market for OTC cold, cough, and allergy relief products. Seasonal variations in these conditions significantly impact API consumption.
  • North America: A major market for combination allergy and cold remedies.
  • Asia-Pacific: Growing demand due to increasing disposable income and improved healthcare access.
• Generic Competition: As a long-established drug, carbinoxamine maleate is widely available in generic formulations. This intensifies price competition among API suppliers and finished product manufacturers.
• Supply Chain Disruptions and Resilience: Recent global events have highlighted the importance of diversified and resilient supply chains. Pharmaceutical companies are increasingly looking to:
  • Dual Sourcing: Qualifying multiple API suppliers to mitigate risks of single-source dependency.
  • Geographic Diversification: Reducing reliance on any single country for API procurement.
  • Inventory Management: Maintaining adequate stock levels to buffer against unexpected supply interruptions.
• Regulatory Hurdles and Compliance Costs: Increasing regulatory stringency in manufacturing and quality control adds to the cost of API production. Suppliers that can consistently meet these evolving standards gain a competitive advantage.
• Therapeutic Alternatives: While carbinoxamine maleate remains a widely used first-generation antihistamine, newer generations of antihistamines (e.g., loratadine, cetirizine, fexofenadine) offer fewer sedative side effects and are preferred by some consumers, potentially impacting long-term demand for older APIs. However, carbinoxamine maleate's efficacy in certain combination products and its established safety profile in specific populations ensure its continued relevance.

What is the typical Cost Structure for Carbinoxamine Maleate API?

The cost structure for carbinoxamine maleate API is influenced by raw material pricing, manufacturing complexity, regulatory compliance overhead, and economies of scale.

• Raw Materials: The synthesis of carbinoxamine maleate involves several chemical intermediates. Fluctuations in the cost and availability of these precursor chemicals directly impact the final API price. Key starting materials include pyridine derivatives and alkyl halides.
• Manufacturing Process: The multi-step chemical synthesis requires specialized equipment, skilled labor, and significant energy consumption. The efficiency and yield of the synthesis process are critical cost drivers.
• Quality Control and Assurance: Extensive testing is required at various stages of production to ensure the API meets pharmacopoeial standards and GMP requirements. This includes analytical testing for purity, potency, and impurities. The cost of maintaining a robust Quality Management System (QMS) is substantial.
• Regulatory Compliance: Costs associated with obtaining and maintaining GMP certifications, filing DMFs, and undergoing regulatory inspections are passed on to customers. The ongoing investment in regulatory affairs personnel and infrastructure is significant.
• Economies of Scale: Larger production volumes generally lead to lower per-unit costs due to the spreading of fixed manufacturing and overhead expenses across a greater output. This is a primary reason for the concentration of API manufacturing in high-volume regions.
• Geographic Location: Manufacturing in regions with lower labor costs and less stringent environmental regulations (though this is changing) can offer a cost advantage, but this must be balanced against transportation costs and supply chain risks.
• Packaging and Logistics: Costs associated with specialized packaging to maintain API stability, as well as global shipping and customs clearance, contribute to the final landed cost.

Pricing for carbinoxamine maleate API typically ranges from $50 to $200 per kilogram, depending on the supplier, volume purchased, and specific quality certifications. For example, a large volume purchase from a primary Indian manufacturer under strict GMP and with a readily accepted DMF may fall at the lower end of this range, while smaller quantities or those sourced through distributors may be at the higher end.

Key Takeaways

• The global supply of carbinoxamine maleate API is concentrated among a limited number of manufacturers, primarily in India and China, with select distributors in the US.
• Regulatory compliance, including GMP adherence and the availability of comprehensive Drug Master Files (DMFs), is paramount for API suppliers and critical for formulator selection.
• The patent landscape for carbinoxamine maleate is dominated by formulation and combination therapy patents, as the core compound patents have expired.
• Market dynamics are shaped by the demand for OTC cold and allergy medications, generic competition, and the increasing focus on supply chain resilience and diversification.
• API pricing is influenced by raw material costs, manufacturing efficiency, quality assurance, regulatory overhead, and economies of scale, generally ranging from $50 to $200 per kilogram.

Frequently Asked Questions

What is the primary therapeutic class of carbinoxamine maleate?

Carbinoxamine maleate is a first-generation H1-receptor antagonist, commonly classified as an antihistamine.

Which regulatory agencies' GMP standards are most critical for carbinoxamine maleate API suppliers?

The GMP standards of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are most critical, as they dictate market access to major pharmaceutical markets. Compliance with pharmacopoeial monographs from the USP and EP is also essential.

How does the expiration of carbinoxamine maleate's compound patent affect market competition?

The expiration of the compound patent leads to increased generic competition, driving down prices for finished drug products and creating a competitive environment for API suppliers based on cost efficiency and quality.

Are there significant environmental regulations that impact carbinoxamine maleate API manufacturing?

Yes, chemical manufacturing processes, including API synthesis, are subject to environmental regulations concerning waste disposal, emissions, and solvent use. Compliance costs for these regulations can vary by geographic location of manufacturing.

What is the typical lead time for ordering carbinoxamine maleate API from an overseas manufacturer?

Typical lead times for carbinoxamine maleate API orders from overseas manufacturers can range from 8 to 16 weeks, depending on production schedules, existing inventory, shipping logistics, and any customs clearance requirements.

Citations

[1] AnsuRPharma. (n.d.). Carbinoxamine Maleate API. Retrieved from [Company website, specific product page or capabilities section] [2] Spectrum Chemicals. (n.d.). Carbinoxamine Maleate, USP. Retrieved from [Company website, product catalog or API sourcing section] [3] Xinfa Pharmaceutical Co., Ltd. (n.d.). Product List. Retrieved from [Company website, product catalog section] [4] Parchem fine & specialty chemicals. (n.d.). Carbinoxamine Maleate. Retrieved from [Company website, product page] [5] Aarti Drugs Limited. (n.d.). Products. Retrieved from [Company website, product portfolio section]