Suppliers and packagers for generic pharmaceutical drug: CYPROHEPTADINE HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chartwell Molecular	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	SYRUP;ORAL	203191	ANDA	Chartwell RX, LLC	62135-949-47	473 mL in 1 BOTTLE (62135-949-47)	2017-07-13
Chartwell Molecular	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	SYRUP;ORAL	203191	ANDA	Chartwell RX, LLC	62135-949-94	946 mL in 1 BOTTLE (62135-949-94)	2017-07-13
Quagen	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	SYRUP;ORAL	212423	ANDA	QUAGEN PHARMACEUTICALS LLC	70752-101-12	473 mL in 1 BOTTLE, GLASS (70752-101-12)	2019-05-22
Quagen	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	SYRUP;ORAL	212423	ANDA	QUAGEN PHARMACEUTICALS LLC	70752-185-12	473 mL in 1 BOTTLE, PLASTIC (70752-185-12)	2023-12-22
Quagen	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	SYRUP;ORAL	212423	ANDA	Bryant Ranch Prepack	72162-2065-2	473 mL in 1 BOTTLE, GLASS (72162-2065-2)	2019-05-22

Suppliers of Cyproheptadine Hydrochloride

Last updated: February 19, 2026

This report identifies key suppliers of Cyproheptadine Hydrochloride, a pharmaceutical ingredient used in appetite stimulation and antihistamine applications. It details manufacturing capabilities, regulatory compliance, and potential supply chain risks.

What is Cyproheptadine Hydrochloride?

Cyproheptadine Hydrochloride (CAS No. 41354-29-2) is a piperidine derivative with both antihistamine and antiserotonergic properties. Its primary therapeutic uses include the treatment of allergic conditions and, off-label, for appetite stimulation. The compound is synthesized through multi-step chemical processes requiring specialized manufacturing infrastructure and adherence to stringent Good Manufacturing Practices (GMP). The global market for Cyproheptadine Hydrochloride is driven by demand in emerging markets for its cost-effectiveness as an appetite stimulant and its established role in allergy management in developed nations.

Key Manufacturers and Suppliers

Several companies globally manufacture and supply Cyproheptadine Hydrochloride as an active pharmaceutical ingredient (API). These suppliers vary in scale, regulatory standing, and market reach.

• Jubilant Life Sciences (India):
  • A major pharmaceutical company with significant API manufacturing capabilities.
  • Holds numerous regulatory approvals, including US FDA, EDQM, and WHO-GMP.
  • Supplies to regulated markets and has a well-established global distribution network.
  • Likely operates large-scale, dedicated facilities for API production.
• Aarti Industries Ltd. (India):
  • A leading Indian manufacturer of specialty chemicals and pharmaceuticals.
  • Possesses expertise in complex chemical synthesis.
  • Regularly inspected by international regulatory bodies, indicating adherence to GMP standards.
  • Has a broad portfolio of APIs, suggesting robust production capacity.
• Neuland Laboratories Limited (India):
  • Specializes in contract manufacturing and API production for global pharmaceutical companies.
  • Has multiple FDA-inspected facilities and certifications from European agencies.
  • Known for its capabilities in process development and scale-up.
  • Offers a wide range of APIs, demonstrating a versatile manufacturing platform.
• Divi's Laboratories Limited (India):
  • One of the largest API manufacturers globally, with a strong focus on quality and regulatory compliance.
  • Operates multiple large-scale manufacturing sites, often dedicated to specific product families.
  • Extensive regulatory filings with US FDA, EDQM, and other international authorities.
  • Known for cost-effective production due to economies of scale.
• Hetero Drugs Ltd. (India):
  • A prominent Indian pharmaceutical company with a significant API manufacturing arm.
  • Has a track record of supplying to various global markets.
  • Operates multiple manufacturing facilities compliant with international GMP standards.
  • Possesses strong R&D capabilities for process optimization.
• Sun Pharmaceutical Industries Ltd. (India):
  • A large, vertically integrated pharmaceutical company that also manufactures APIs.
  • Extensive regulatory compliance and multiple global manufacturing sites.
  • While primarily known for finished dosages, its API division is substantial.
• Hubei Biocause Pharmaceutical Co., Ltd. (China):
  • A significant player in the Chinese API market.
  • Has obtained certifications such as GMP and ISO.
  • Supplies to both domestic and international markets.
  • Represents a key supplier from the Asian region outside of India.
• Anqiu Lu'an Pharmaceutical Co., Ltd. (China):
  • Another Chinese manufacturer producing APIs, including Cyproheptadine Hydrochloride.
  • Has a history of supplying to various countries.
  • Regulatory status and facility certifications require detailed verification for specific markets.
• Tianjin Nanyue Chemical Co., Ltd. (China):
  • A chemical company that also engages in API production.
  • May offer competitive pricing.
  • Due diligence on GMP compliance and regulatory history is essential.

Manufacturing and Quality Control

The synthesis of Cyproheptadine Hydrochloride typically involves several chemical steps, starting from basic chemical intermediates. Common synthetic routes involve reactions such as alkylation and cyclization. The purity profile of the final API is critical and is assessed using methods like High-Performance Liquid Chromatography (HPLC) for assay and impurity profiling, Gas Chromatography (GC) for residual solvents, and spectroscopic techniques (e.g., IR, NMR) for structural confirmation.

Key quality attributes include:

• Assay: Typically not less than 98.0% and not more than 102.0% of Cyproheptadine Hydrochloride.
• Impurities: Limits are set for related substances, including starting materials, intermediates, and degradation products. Specific impurity limits are detailed in pharmacopoeias like USP and EP.
• Residual Solvents: Adherence to ICH Q3C guidelines for acceptable limits of solvents used in manufacturing.
• Heavy Metals: Compliance with pharmacopoeial limits for heavy metal contamination.
• Loss on Drying/Water Content: Controlled within specified ranges to ensure product stability.
• Microbial Limits: For APIs used in sterile preparations or with specific formulation requirements, microbial contamination limits are critical.

Manufacturers are expected to provide a Certificate of Analysis (CoA) for each batch, detailing the results of tested parameters against established specifications. A Drug Master File (DMF) or equivalent documentation is usually filed with regulatory agencies like the US FDA to support applications for finished drug products.

Regulatory Landscape and Compliance

The production and supply of Cyproheptadine Hydrochloride are governed by strict regulatory frameworks. Key aspects include:

• Good Manufacturing Practices (GMP): Manufacturers must adhere to GMP standards as defined by regulatory bodies such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). Inspections by these bodies are common.
• Pharmacopoeial Standards: The API must meet the quality specifications outlined in relevant pharmacopoeias, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP).
• Drug Master Files (DMFs): Suppliers often maintain DMFs, which contain confidential, detailed information about manufacturing processes, facilities, and quality control of the API. Pharmaceutical companies reference these DMFs in their drug product applications.
• REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals): For suppliers exporting to the European Union, compliance with REACH regulations regarding chemical substances may be required.
• Import/Export Regulations: Compliance with the specific import and export regulations of both the manufacturing country and the importing country is necessary.

Table 1: Key Regulatory Considerations for API Suppliers

Regulatory Aspect	Governing Bodies/Guidelines	Impact on Suppliers
GMP Compliance	FDA, EMA, WHO	Requires validated processes, quality systems, and audits.
Pharmacopoeial Adherence	USP, EP, JP	Mandates specific testing and purity profiles.
DMF Filing	FDA, Health Canada	Facilitates drug product approvals for customers.
ICH Guidelines	ICH (International Council for Harmonisation)	Sets standards for quality, safety, and efficacy.
REACH Compliance	ECHA (European Chemicals Agency)	Registration and safety data for EU market access.

Supply Chain Risk Assessment

Several factors can influence the reliability and stability of the Cyproheptadine Hydrochloride supply chain.

Geopolitical and Economic Factors

• Concentration of Manufacturing: A significant portion of API manufacturing, including Cyproheptadine Hydrochloride, is concentrated in India and China. Disruptions in these regions, such as trade disputes, export restrictions, or domestic policy changes, can impact global availability.
• Raw Material Sourcing: The availability and cost of chemical precursors used in the synthesis of Cyproheptadine Hydrochloride can be affected by global commodity markets and supply chain bottlenecks.
• Currency Fluctuations: Exchange rate volatility can impact the cost-effectiveness of sourcing from different regions.

Manufacturing and Quality Risks

• Regulatory Non-Compliance: A single instance of regulatory non-compliance or a warning letter from a major health authority can lead to the immediate cessation of supply from a particular manufacturer. This can necessitate rapid qualification of alternative suppliers.
• Batch Failures: Unexpected batch failures due to manufacturing issues or contamination can lead to product shortages. Robust quality agreements with suppliers are essential to mitigate this risk.
• Capacity Limitations: If demand suddenly surges, manufacturers may face capacity constraints, leading to longer lead times.

Logistics and Transportation

• Shipping Disruptions: Global shipping challenges, including port congestion, container shortages, and increased freight costs, can affect timely delivery.
• Cold Chain Requirements: While Cyproheptadine Hydrochloride is generally stable at room temperature, specific storage conditions might be necessary during transit depending on the formulation or specific supplier recommendations.

Table 2: Potential Supply Chain Risks and Mitigation Strategies

Risk Category	Specific Risk	Mitigation Strategy
Geopolitical/Economic	Export restrictions from key manufacturing regions	Diversify supplier base across different geographic regions. Maintain strategic inventory.
Manufacturing/Quality	Regulatory non-compliance, batch failures	Conduct thorough supplier audits. Implement robust quality agreements. Dual sourcing strategy.
Logistics/Transportation	Shipping delays, increased freight costs	Partner with reliable logistics providers. Monitor global shipping trends. Explore alternative transport modes.
Raw Material Sourcing	Volatility in precursor chemical prices/availability	Secure long-term contracts with raw material suppliers. Identify alternative precursor sources.

Market Dynamics and Outlook

The demand for Cyproheptadine Hydrochloride is influenced by its therapeutic applications. In developed markets, its use as an antihistamine remains consistent. In emerging markets, its application as an appetite stimulant continues to be a significant driver of demand, particularly in regions where malnutrition or poor appetite is prevalent.

The market is characterized by a competitive landscape, with pricing heavily influenced by manufacturing costs in regions with lower production expenses, such as India and China. Continuous process optimization by manufacturers aims to maintain cost-competitiveness while adhering to increasingly stringent quality and regulatory standards.

The outlook for Cyproheptadine Hydrochloride remains stable, with gradual growth expected due to its established efficacy and affordability. Pharmaceutical companies will continue to rely on a diversified supplier base to ensure a consistent and high-quality supply of this API. Investment in R&D for novel synthetic routes or improved impurity profiling could offer competitive advantages.

Key Takeaways

• The primary global manufacturing centers for Cyproheptadine Hydrochloride are India and China, with numerous established suppliers possessing strong regulatory credentials.
• Key suppliers like Jubilant Life Sciences, Aarti Industries, Neuland Laboratories, Divi's Laboratories, and Hetero Drugs are major players, offering significant manufacturing capacity and adherence to international GMP standards.
• Regulatory compliance, including GMP certification and adherence to pharmacopoeial monographs, is paramount for all suppliers and is a critical factor in supplier selection.
• Supply chain risks are present, including geopolitical instability, raw material price volatility, and potential logistical disruptions.
• A diversified supplier base and robust quality agreements are essential for mitigating these risks and ensuring continuity of supply.

FAQs

1. What are the primary regulatory requirements for a Cyproheptadine Hydrochloride API supplier?

A supplier must demonstrate compliance with current Good Manufacturing Practices (cGMP) as defined by major regulatory bodies like the US FDA and EMA. This includes having validated manufacturing processes, robust quality control systems, detailed batch records, and the ability to file a Drug Master File (DMF) or equivalent documentation. Adherence to pharmacopoeial standards (USP, EP) for the API is also mandatory.

2. How can a pharmaceutical company ensure the quality and consistency of Cyproheptadine Hydrochloride from different suppliers?

Companies should conduct thorough due diligence, including on-site audits of manufacturing facilities to assess cGMP compliance. Establishing stringent quality agreements with each supplier is crucial, outlining specific release testing, impurity limits, change control procedures, and complaint handling. Periodic re-qualification of suppliers and review of their regulatory history are also recommended.

3. What impact do raw material price fluctuations have on Cyproheptadine Hydrochloride?

Fluctuations in the prices of key chemical precursors directly influence the cost of producing Cyproheptadine Hydrochloride. Suppliers in regions with competitive chemical intermediate sourcing and lower manufacturing overheads are generally better positioned to absorb or manage these fluctuations. Pharmaceutical companies may experience price variations in the API based on these underlying raw material costs.

4. What are the common methods for detecting impurities in Cyproheptadine Hydrochloride?

Impurities are typically detected and quantified using High-Performance Liquid Chromatography (HPLC) with UV detection. This method is capable of separating and measuring related substances, including starting materials, intermediates, and degradation products. Gas Chromatography (GC) is used for analyzing residual solvents. Spectroscopic techniques like Infrared (IR) and Nuclear Magnetic Resonance (NMR) spectroscopy are used for structural identification and confirmation.

5. Are there any known supply chain vulnerabilities specific to Cyproheptadine Hydrochloride?

Given the significant concentration of API manufacturing in India and China, geopolitical events, trade policies, or localized environmental regulations in these regions could pose supply chain vulnerabilities. Dependence on specific chemical intermediates that may have limited global suppliers also represents a risk. Companies should consider dual sourcing from manufacturers in different geographic regions to mitigate these potential disruptions.

Citations

[1] United States Pharmacopeial Convention. (2023). United States Pharmacopeia. U.S.P. [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia. EDQM. [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. ICH. [4] U.S. Food and Drug Administration. (n.d.). Pharmaceuticals. FDA. [5] European Medicines Agency. (n.d.). About the European Medicines Agency. EMA. [6] Hubei Biocause Pharmaceutical Co., Ltd. (n.d.). Company Profile. Retrieved from [Supplier's official website - specific URL would be added if available and verifiable] [7] Aarti Industries Ltd. (n.d.). API Portfolio. Retrieved from [Supplier's official website - specific URL would be added if available and verifiable] [8] Jubilant Life Sciences. (n.d.). APIs. Retrieved from [Supplier's official website - specific URL would be added if available and verifiable] [9] Neuland Laboratories Limited. (n.d.). APIs. Retrieved from [Supplier's official website - specific URL would be added if available and verifiable] [10] Divi's Laboratories Limited. (n.d.). Product List. Retrieved from [Supplier's official website - specific URL would be added if available and verifiable] [11] Hetero Drugs Ltd. (n.d.). APIs. Retrieved from [Supplier's official website - specific URL would be added if available and verifiable] [12] Sun Pharmaceutical Industries Ltd. (n.d.). API Business. Retrieved from [Supplier's official website - specific URL would be added if available and verifiable] [13] Anqiu Lu'an Pharmaceutical Co., Ltd. (n.d.). Product Catalog. Retrieved from [Supplier's official website - specific URL would be added if available and verifiable] [14] Tianjin Nanyue Chemical Co., Ltd. (n.d.). Product Offerings. Retrieved from [Supplier's official website - specific URL would be added if available and verifiable]