Suppliers and packagers for generic pharmaceutical drug: CLOMIPRAMINE HYDROCHLORIDE

CLOMIPRAMINE 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
Specgx Llc	ANAFRANIL	clomipramine hydrochloride	CAPSULE;ORAL	019906	NDA	SpecGx LLC	0406-8806-01	100 CAPSULE in 1 BOTTLE (0406-8806-01)	2015-06-01
Specgx Llc	ANAFRANIL	clomipramine hydrochloride	CAPSULE;ORAL	019906	NDA	SpecGx LLC	0406-8807-01	100 CAPSULE in 1 BOTTLE (0406-8807-01)	2015-06-01
Specgx Llc	ANAFRANIL	clomipramine hydrochloride	CAPSULE;ORAL	019906	NDA	SpecGx LLC	0406-8808-01	100 CAPSULE in 1 BOTTLE (0406-8808-01)	2015-06-01

Clomipramine Hydrochloride: Global Supplier Landscape and Patent Considerations

Last updated: February 19, 2026

This analysis identifies key global suppliers of Clomipramine Hydrochloride, examines their production capabilities, and reviews the patent landscape impacting its generic market entry and established manufacturing. The data presented aids strategic sourcing and R&D investment decisions for pharmaceutical companies.

What are the primary uses and therapeutic indications for Clomipramine Hydrochloride?

Clomipramine Hydrochloride is a tricyclic antidepressant (TCA) primarily indicated for the treatment of obsessive-compulsive disorder (OCD). Its efficacy extends to panic disorder, including agoraphobia, and it is also used for major depressive disorder, often as an adjunctive treatment when other antidepressants are insufficient. The drug's mechanism of action involves inhibiting the reuptake of serotonin and norepinephrine, thereby increasing the concentration of these neurotransmitters in the synaptic cleft. This neurochemical modulation is central to its therapeutic effect in the aforementioned psychiatric conditions.

Who are the major global manufacturers and suppliers of Clomipramine Hydrochloride API?

The global supply of Clomipramine Hydrochloride Active Pharmaceutical Ingredient (API) is concentrated among a limited number of manufacturers, primarily located in India and China. These suppliers cater to both generic drug producers and contract manufacturing organizations (CMOs).

Key Suppliers of Clomipramine Hydrochloride API:

• Laurus Labs Ltd. (India): A significant player in API manufacturing, Laurus Labs has demonstrated capabilities in producing various psychiatric drug intermediates and APIs. Their facilities are compliant with international regulatory standards.
• Divi’s Laboratories Limited (India): Known for its large-scale API production, Divi's is a prominent supplier of complex APIs. The company has a strong track record in process development and manufacturing efficiency.
• Sun Pharmaceutical Industries Ltd. (India): While primarily a finished dosage form manufacturer, Sun Pharma also engages in API production and has the capacity to supply Clomipramine Hydrochloride.
• Dr. Reddy's Laboratories Ltd. (India): A leading Indian pharmaceutical company with extensive API manufacturing expertise. They supply a broad portfolio of APIs to global markets.
• Cipla Limited (India): Another major Indian pharmaceutical firm with established API manufacturing operations and a global distribution network.
• Teva Pharmaceutical Industries Ltd. (Israel): As a significant generic drug manufacturer, Teva has integrated API production capabilities, which may include Clomipramine Hydrochloride for its own product lines and potentially for external sales.
• Anacapri SRL (Italy): This European manufacturer focuses on niche APIs and specialty chemicals, potentially offering Clomipramine Hydrochloride.
• Aarti Industries Limited (India): A diversified chemical company with a strong presence in pharmaceutical intermediates and APIs.

These suppliers generally possess Good Manufacturing Practices (GMP) certifications and supply APIs that meet pharmacopoeial standards such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia). Production capacities vary, but leading manufacturers can produce metric tons of API annually to meet global demand.

What is the patent landscape surrounding Clomipramine Hydrochloride?

The original patent protection for Clomipramine Hydrochloride has long expired, allowing for generic competition. However, patents can exist for specific polymorphic forms, novel formulations, improved synthesis routes, or new therapeutic uses.

Key Patent Considerations:

• Original Composition of Matter Patent: Expired. The fundamental patent covering the Clomipramine Hydrochloride molecule was granted to Geigy (later Ciba-Geigy, now Novartis) in the early 1960s. This patent's expiration opened the door for generic manufacturers.
• Formulation Patents: While less common for older drugs, new patent applications may emerge for specific drug delivery systems or sustained-release formulations of Clomipramine Hydrochloride. Such patents, if granted, could offer a limited period of market exclusivity for those specific formulations.
• Process Patents: Improvements in the chemical synthesis of Clomipramine Hydrochloride can be patented. Companies may develop and patent more efficient, cost-effective, or environmentally friendly manufacturing processes. These patents would not block the sale of the drug itself but could prevent competitors from using the patented manufacturing method. For example, patents might cover specific catalysts, reaction conditions, or purification techniques.
• Polymorph Patents: Different crystalline forms (polymorphs) of an API can have distinct physical properties, such as solubility and bioavailability. Patents covering specific, advantageous polymorphs of Clomipramine Hydrochloride could exist. Companies holding such patents would have exclusivity over the use and sale of the API in that particular crystalline form.
• New Use Patents: While Clomipramine Hydrochloride is established for OCD and depression, ongoing research might identify new therapeutic indications. Patents for these novel uses could be granted, providing exclusivity for the drug's application in those specific new indications.

Analyzing the current patent landscape requires detailed searches of patent databases such as USPTO, EPO, WIPO, and national patent offices. Key terms for searches would include "Clomipramine Hydrochloride," "synthesis," "formulation," "polymorph," and specific chemical identifiers. This due diligence is crucial for any company considering new product development or market entry to avoid infringement.

What are the regulatory requirements for Clomipramine Hydrochloride API manufacturing and supply?

Manufacturing and supplying Clomipramine Hydrochloride API are subject to stringent regulatory oversight to ensure product quality, safety, and efficacy. Key regulatory bodies include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national health authorities in other countries.

Core Regulatory Requirements:

• Good Manufacturing Practices (GMP): Manufacturers must adhere to current GMP guidelines established by regulatory agencies. This encompasses all aspects of production, including personnel training, facility design and maintenance, equipment qualification and calibration, material control, process validation, laboratory controls, documentation, and quality management systems. For example, the FDA's 21 CFR Part 210/211 and EMA's EudraLex Volume 4 provide detailed GMP frameworks.
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. A DMF is a submission to regulatory authorities containing detailed information about the facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows regulatory bodies to review API information confidentially when evaluating a drug product application.
• Pharmacopoeial Compliance: The API must meet the specifications outlined in relevant pharmacopoeias, such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or Japanese Pharmacopoeia (JP). These monographs define identity, purity, strength, and quality test methods.
• Impurity Profiling and Control: Manufacturers must identify, quantify, and control impurities, including residual solvents, heavy metals, and process-related byproducts. Regulatory guidelines, such as ICH Q3A (R2) for impurities in new drug substances, set thresholds for reporting, identification, and qualification of impurities.
• Stability Studies: Manufacturers must conduct stability studies to determine the shelf-life and recommended storage conditions for the API. These studies, guided by ICH Q1A (R2), assess how the API's quality varies over time under different environmental conditions (temperature, humidity, light).
• Site Inspections and Audits: Manufacturing facilities are subject to periodic inspections by regulatory authorities and audits by their customers. Successful inspections and audits are essential for maintaining regulatory compliance and market access.
• Change Control: Any changes to the manufacturing process, equipment, or materials must be managed through a formal change control system, documented, and evaluated for their impact on API quality. Significant changes may require notification or prior approval from regulatory agencies.

Compliance with these regulations is non-negotiable for API suppliers seeking to serve regulated pharmaceutical markets.

How does the market for Clomipramine Hydrochloride API compare to other TCAs?

The market for Clomipramine Hydrochloride API is a segment within the broader antidepressant market, specifically for tricyclic antidepressants (TCAs). Compared to other TCAs, Clomipramine Hydrochloride occupies a niche but critical position due to its unique efficacy in OCD.

Comparative Market Position:

• Market Size: The global market for Clomipramine Hydrochloride API is smaller than that for broader-spectrum antidepressants like Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs). However, within the TCAs class, it is a significant product.
• Therapeutic Niche: Clomipramine Hydrochloride's primary strength is its robust efficacy in treating OCD, a condition for which it remains a first-line or key second-line option in many treatment guidelines. This specific indication differentiates it from TCAs primarily used for depression, such as Amitriptyline or Nortriptyline.
• Competition: Within the TCA class, Clomipramine Hydrochloride faces competition from other TCAs for depression and from the widely prescribed SSRIs and SNRIs for both depression and anxiety disorders. The rise of newer antidepressant classes has generally reduced the overall market share of TCAs for depression. However, for OCD, Clomipramine Hydrochloride maintains a strong competitive position.
• Generic Penetration: Like most older TCAs, Clomipramine Hydrochloride is predominantly a generic drug. The market is characterized by price competition among API suppliers and finished dosage form manufacturers. This contrasts with newer, patented antidepressants that command higher prices.
• API Supplier Landscape: The API supplier landscape for Clomipramine Hydrochloride is relatively consolidated, with a few key Indian and Chinese manufacturers dominating global supply. This is similar to many other established generic APIs. The complexity of synthesis and regulatory hurdles can limit new entrants.
• Growth Drivers: Demand for Clomipramine Hydrochloride API is driven by the prevalence of OCD and, to a lesser extent, treatment-resistant depression. Factors influencing growth include diagnostic rates, physician prescribing patterns, and the availability and affordability of generic treatments.

Overall, the Clomipramine Hydrochloride API market is stable, driven by its established therapeutic role in OCD. While not as large as the market for broader antidepressants, its specialized efficacy ensures continued demand.

What are the key considerations for sourcing Clomipramine Hydrochloride API?

Sourcing Clomipramine Hydrochloride API involves a multi-faceted assessment of suppliers to ensure consistent quality, regulatory compliance, supply chain reliability, and cost-effectiveness.

Key Sourcing Considerations:

• Regulatory Compliance and Quality Assurance:

  • GMP Certification: Verify current GMP certification from major regulatory bodies (FDA, EMA, etc.) and review recent inspection reports.
  • DMF Status: Ensure a comprehensive and up-to-date Drug Master File is available and accessible.
  • Pharmacopoeial Compliance: Confirm that the API meets USP, EP, or other relevant pharmacopoeial standards, evidenced by Certificates of Analysis (CoAs).
  • Impurity Profile: Obtain detailed impurity profiles and confirm the supplier's control strategy aligns with ICH guidelines.
  • Quality Management System: Assess the robustness of the supplier's QMS, including their change control, deviation, and CAPA (Corrective and Preventive Actions) procedures.

• Supply Chain Reliability and Capacity:

  • Production Capacity: Evaluate the supplier's manufacturing capacity to meet projected demand and assess their ability to scale up if necessary.
  • Lead Times: Understand standard production lead times and inquire about expedited order processing capabilities.
  • Supply Chain Risk: Assess risks associated with the supplier's geographic location (geopolitical stability, natural disaster potential), reliance on single raw material sources, and financial health.
  • Business Continuity Plan: Inquire about the supplier's BCP to ensure uninterrupted supply in case of unforeseen events.

• Technical Capabilities and Support:

  • Process Understanding: Engage with the supplier's technical team to understand their synthesis route, purification methods, and analytical capabilities.
  • Technical Support: Evaluate the supplier's responsiveness and expertise in providing technical support for formulation development, troubleshooting, and regulatory queries.
  • Analytical Methods: Review the validated analytical methods used by the supplier for API testing.

• Cost and Commercial Terms:

  • Pricing: Negotiate competitive pricing based on volume, contract duration, and market benchmarks.
  • Payment Terms: Agree on clear and mutually acceptable payment terms.
  • Contractual Agreements: Establish robust supply agreements covering quality, delivery, pricing, intellectual property (if applicable), and dispute resolution.

• Auditing and Relationship Management:

  • Supplier Audits: Conduct thorough on-site audits of potential suppliers to verify compliance and assess operational capabilities.
  • Ongoing Monitoring: Implement a system for ongoing performance monitoring, including regular review of CoAs, audit outcomes, and supplier responsiveness.
  • Partnership Approach: Foster a collaborative relationship with key suppliers to enhance transparency and problem-solving.

A meticulous due diligence process, encompassing all these aspects, is essential for securing a reliable and compliant source of Clomipramine Hydrochloride API.

Key Takeaways

The global supply of Clomipramine Hydrochloride API is primarily driven by manufacturers in India and China, including Laurus Labs, Divi's Laboratories, and Sun Pharma. Original composition of matter patents have expired, allowing for generic market entry. However, potential patent protection may exist for novel formulations, specific polymorphic forms, or improved synthesis processes. Regulatory compliance, including adherence to GMP, submission of DMFs, and meeting pharmacopoeial standards, is critical for all API suppliers. The Clomipramine Hydrochloride API market is a stable segment within the broader antidepressant landscape, characterized by its distinct therapeutic niche in treating Obsessive-Compulsive Disorder. Sourcing decisions must prioritize regulatory compliance, supply chain reliability, technical support, and competitive pricing, often involving thorough supplier audits and robust contractual agreements.

Frequently Asked Questions

1. Are there any active patents that could prevent the generic sale of Clomipramine Hydrochloride? While the original composition of matter patent has expired, patents could exist for specific advantageous polymorphic forms, novel drug delivery systems, or significantly improved manufacturing processes. A comprehensive patent landscape analysis is required to confirm freedom to operate.

2. What is the typical shelf-life for Clomipramine Hydrochloride API, and how is it determined? The typical shelf-life for Clomipramine Hydrochloride API is generally between 2 to 5 years, contingent on packaging and storage conditions. Shelf-life is determined through comprehensive stability studies conducted according to ICH guidelines (e.g., ICH Q1A(R2)), which involve storing the API under various temperature, humidity, and light conditions and testing its quality attributes at predetermined intervals.

3. How do impurity profiles for Clomipramine Hydrochloride API differ between suppliers? Impurity profiles can vary between suppliers due to differences in their synthesis routes, raw material quality, and purification techniques. Regulatory agencies require detailed impurity profiling, and suppliers must control impurities within acceptable limits defined by ICH guidelines (e.g., ICH Q3A(R2)). Customers should obtain and review these profiles for any potential impact on their finished product.

4. What are the primary regulatory hurdles for a new supplier entering the Clomipramine Hydrochloride API market? A new supplier must establish GMP-compliant manufacturing facilities, validate their synthesis and purification processes, develop robust analytical methods, and prepare and submit a comprehensive Drug Master File (DMF) to relevant regulatory authorities (e.g., FDA, EMA). Successful facility inspections are also a mandatory step.

5. How does the cost of Clomipramine Hydrochloride API compare to newer antidepressants? As an established, generic medication, Clomipramine Hydrochloride API is significantly less expensive than patented, newer classes of antidepressants such as SSRIs, SNRIs, or novel agents. The cost is primarily driven by manufacturing efficiency, raw material costs, and market competition among API suppliers, rather than R&D investment for patent exclusivity.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Code of Federal Regulations, Title 21, Part 210/211. Retrieved from https://www.accessdata.fda.gov/ [2] European Medicines Agency. (n.d.). EudraLex - The Rules Governing Medicinal Products in the European Union, Volume 4. Retrieved from https://www.ema.europa.eu/ [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). ICH Harmonised Tripartite Guideline: Impurities in New Drug Substances Q3A(R2). [4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2003). ICH Harmonised Tripartite Guideline: Stability Testing of New Drug Substances and Products Q1A(R2). [5] United States Pharmacopeia. (n.d.). The United States Pharmacopeia. Retrieved from https://www.usp.org/ [6] European Pharmacopoeia. (n.d.). European Pharmacopoeia. Retrieved from https://www.edqm.eu/