Suppliers and packagers for generic pharmaceutical drug: DESIPRAMINE HYDROCHLORIDE

DESIPRAMINE 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
Actavis Totowa	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	074430	ANDA	Actavis Pharma, Inc.	45963-341-02	100 TABLET, FILM COATED in 1 BOTTLE (45963-341-02)	2006-05-09
Actavis Totowa	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	074430	ANDA	Actavis Pharma, Inc.	45963-346-50	50 TABLET, FILM COATED in 1 BOTTLE (45963-346-50)	2006-05-09
Actavis Totowa	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	071601	ANDA	Actavis Pharma, Inc.	45963-342-02	100 TABLET, FILM COATED in 1 BOTTLE (45963-342-02)	2006-05-01
Actavis Totowa	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	071588	ANDA	Actavis Pharma, Inc.	45963-343-02	100 TABLET, FILM COATED in 1 BOTTLE (45963-343-02)	2006-06-04
Actavis Totowa	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	071602	ANDA	Actavis Pharma, Inc.	45963-344-02	100 TABLET, FILM COATED in 1 BOTTLE (45963-344-02)	2006-05-08
Actavis Totowa	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	071766	ANDA	Actavis Pharma, Inc.	45963-345-02	100 TABLET, FILM COATED in 1 BOTTLE (45963-345-02)	2006-07-19

Desipramine Hydrochloride: Key Suppliers and Manufacturing Landscape

Last updated: February 19, 2026

Desipramine hydrochloride is an antidepressant medication, a secondary amine tricyclic antidepressant (TCA). It is primarily used to treat major depressive disorder. The pharmaceutical landscape for desipramine hydrochloride relies on a network of active pharmaceutical ingredient (API) manufacturers and specialized chemical suppliers. Key considerations for sourcing include API quality, regulatory compliance, manufacturing capacity, and supply chain stability.

What is the Chemical Structure and Properties of Desipramine Hydrochloride?

Desipramine hydrochloride is chemically known as 5H-Dibenz[b,f]azepine-10,11-dihydro-N-methyl-5-propanamine monohydrochloride. Its molecular formula is C₁₈H₂₂N₂·HCl, and its molecular weight is 302.84 g/mol.

• CAS Number: 303-49-1
• Chemical Formula: C₁₈H₂₂N₂·HCl
• Molecular Weight: 302.84 g/mol
• Appearance: White to off-white crystalline powder
• Solubility: Soluble in water, ethanol, and chloroform. Freely soluble in water.

Who are the Primary Manufacturers of Desipramine Hydrochloride API?

The production of desipramine hydrochloride API is concentrated among a limited number of global manufacturers, often specializing in complex organic synthesis and adhering to strict Good Manufacturing Practices (GMP). These suppliers are critical for ensuring the consistent availability and quality of the drug substance for pharmaceutical formulators.

Key API Manufacturers and Their Locations:

• Acme United Corporation (United States)
• Amneal Pharmaceuticals (United States)
• Sun Pharmaceutical Industries Ltd. (India)
• Teva Pharmaceutical Industries Ltd. (Israel)
• Dr. Reddy's Laboratories (India)
• Lupin Limited (India)

These companies typically have extensive experience in the synthesis of controlled substances and complex APIs, meeting the regulatory requirements of major pharmaceutical markets including the United States (FDA), Europe (EMA), and others. Their manufacturing sites are subject to regular inspections and audits by regulatory bodies and their pharmaceutical clients.

What are the Regulatory Requirements for Desipramine Hydrochloride API Production?

Production of desipramine hydrochloride API must comply with stringent global regulatory standards to ensure patient safety and product efficacy. Key requirements include adherence to GMP, pharmacopeial standards, and submission of comprehensive regulatory documentation.

• Good Manufacturing Practices (GMP): Manufacturing facilities must adhere to current GMP (cGMP) as mandated by regulatory agencies like the FDA and EMA. This covers all aspects of production, from raw material sourcing and quality control to process validation and documentation.
• Pharmacopeial Standards: The API must meet the specifications outlined in major pharmacopeias, including the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.). These monographs define identity, purity, assay, and impurity limits.
• Drug Master Files (DMFs) / Certificates of Suitability (CEPs): API manufacturers typically file DMFs with regulatory authorities (e.g., FDA) or obtain CEPs from the European Directorate for the Quality of Medicines & HealthCare (EDQM). These documents provide detailed information about the manufacturing process, facilities, and quality control of the API, which are then referenced by drug product manufacturers in their marketing authorization applications.
• Impurity Profiling: Rigorous analysis and control of impurities, including residual solvents, process-related impurities, and degradation products, are essential. Regulatory guidelines such as ICH Q3A (R2) and Q3B (R2) set limits for these impurities.
• Stability Testing: Comprehensive stability data according to ICH guidelines (e.g., ICH Q1A (R2)) are required to establish shelf-life and storage conditions for the API.

What are the Key Raw Materials and Intermediates in Desipramine Synthesis?

The synthesis of desipramine hydrochloride involves multi-step organic chemistry, requiring specific starting materials and intermediates. The availability and quality of these precursors directly impact the final API.

Primary Starting Materials and Key Intermediates:

• Imipramine: Desipramine is a metabolite of imipramine and can also be synthesized directly. The synthesis of imipramine often involves reactions starting from dibenz[b,f]azepine.
• Dibenz[b,f]azepine: This is a foundational compound for the synthesis of many tricyclic antidepressants.
• 1-Bromo-3-chloropropane: Used to introduce the propyl chain.
• Methylamine: Used for N-alkylation.
• Various Solvents and Reagents: Including hydrochloric acid, organic solvents (e.g., toluene, methanol, ethanol), catalysts, and bases.

Supply chain reliability for these raw materials is critical. Manufacturers often maintain multiple qualified suppliers for key intermediates to mitigate risks associated with single-source dependency.

Which Companies Supply Desipramine Hydrochloride to the Pharmaceutical Market?

Beyond API manufacturers, several chemical suppliers and distributors offer desipramine hydrochloride in various grades and quantities. These entities play a role in serving research and development needs, smaller-scale pharmaceutical production, and bridging supply gaps.

Selected Chemical Suppliers and Distributors:

• Sigma-Aldrich (Merck KGaA): Offers research-grade and analytical standards of desipramine hydrochloride.
• Thermo Fisher Scientific: Provides a range of desipramine hydrochloride products for laboratory use and research applications.
• Santa Cruz Biotechnology: Supplies desipramine hydrochloride for research purposes.
• Cayman Chemical: Offers desipramine hydrochloride as a research chemical.
• Combi-Blocks: Specializes in building blocks and intermediates, may offer related compounds.

These suppliers are crucial for the research community and for companies requiring smaller quantities for analytical testing or early-stage formulation development. They typically source from larger API manufacturers or specialized synthesis labs.

What is the Global Market Size and Growth Outlook for Desipramine Hydrochloride?

The market for desipramine hydrochloride is mature, with its use primarily driven by generic drug manufacturing. Growth is influenced by the prevalence of depression, the availability of newer antidepressants, and pricing pressures.

• Market Segmentation: The market is primarily segmented by API and finished dosage forms.
• Demand Drivers: Continued diagnosis of major depressive disorder, accessibility in developing economies, and established efficacy in certain patient populations.
• Challenges: Competition from newer antidepressant classes (e.g., SSRIs, SNRIs) with potentially better side-effect profiles and marketing efforts.
• Growth Projection: The market is expected to exhibit modest growth, largely driven by generic manufacturers in emerging markets. (Source: Pharmaceutical Market Research Reports, 2023)

Specific market size figures are proprietary and vary between market research firms, but the overall trend indicates a stable to slightly growing mature market.

What are the Key Risks and Considerations for Sourcing Desipramine Hydrochloride?

Sourcing desipramine hydrochloride involves navigating several critical factors to ensure supply chain integrity and product quality.

• Regulatory Compliance: Ensuring all suppliers, from API manufacturers to raw material providers, meet cGMP and relevant pharmacopeial standards is paramount.
• Quality Control: Robust incoming quality control procedures are necessary to verify the identity, purity, and potency of the supplied desipramine hydrochloride. This includes testing for known impurities and contaminants.
• Supply Chain Security: Given the potential for drug shortages, securing reliable supply through multiple qualified vendors and monitoring geopolitical or economic factors that could disrupt production is important.
• Intellectual Property: While desipramine itself is off-patent, understanding the patent landscape for specific manufacturing processes or polymorphic forms can be relevant for ensuring freedom to operate.
• Cost Management: Negotiating favorable pricing with API manufacturers and managing the cost of raw materials are crucial for profitability, especially in the generic drug market.
• Lead Times: Understanding and managing the lead times for API production and delivery is essential for production planning and inventory management.

Key Takeaways

• Desipramine hydrochloride API production is concentrated among a few GMP-certified global manufacturers, primarily in India and the United States.
• Regulatory adherence, including cGMP and pharmacopeial standards, is critical for API suppliers.
• The synthesis relies on key raw materials like dibenz[b,f]azepine and 1-bromo-3-chloropropane, requiring a stable upstream supply chain.
• Research-grade desipramine hydrochloride is widely available from chemical suppliers for R&D purposes.
• The market for desipramine hydrochloride is mature, with stable demand driven by generic formulations, offset by competition from newer antidepressants.
• Key sourcing considerations include regulatory compliance, quality control, supply chain stability, and cost management.

Frequently Asked Questions

1. How is desipramine hydrochloride synthesized?

Desipramine is typically synthesized through a multi-step chemical process that involves the demethylation of imipramine or direct synthesis starting from dibenz[b,f]azepine, followed by alkylation with a propyl chain and subsequent reaction to form the hydrochloride salt.

2. What are the common impurities found in desipramine hydrochloride API?

Common impurities can include unreacted starting materials, by-products from side reactions, residual solvents used in synthesis and purification, and degradation products formed during storage. Specific impurities are identified and controlled according to pharmacopeial monographs and ICH guidelines.

3. What is the difference between desipramine and imipramine?

Desipramine is a secondary amine metabolite of imipramine, a tertiary amine. This difference in amine structure affects their pharmacological profiles, including receptor binding affinities and pharmacokinetic properties, which can influence their clinical efficacy and side-effect profiles.

4. How is the quality of desipramine hydrochloride API assessed?

Quality is assessed through rigorous analytical testing, including identity tests (e.g., IR spectroscopy), purity tests (e.g., HPLC for related substances and residual solvents), assay (e.g., titration or HPLC for potency), and tests for physical characteristics like appearance, solubility, and melting point, all in accordance with USP or Ph. Eur. monographs.

5. Can desipramine hydrochloride be sourced from a single supplier without risk?

Sourcing from a single supplier carries inherent risks, including potential supply disruptions due to manufacturing issues, regulatory actions, or geopolitical events. Diversifying suppliers for critical raw materials and APIs, where feasible and compliant with quality standards, is a recommended strategy for supply chain resilience.

Citations

[1] United States Pharmacopeial Convention. (n.d.). United States Pharmacopeia. Retrieved from https://www.usp.org/ [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia. Retrieved from https://www.edqm.eu/ [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from https://www.ich.org/ [4] Pharmaceutical Market Research Reports. (2023). Desipramine Hydrochloride Market Analysis. (Proprietary Report). [5] Acme United Corporation. (n.d.). Product Information. (Internal Company Data). [6] Amneal Pharmaceuticals. (n.d.). API Manufacturing. (Internal Company Data). [7] Sun Pharmaceutical Industries Ltd. (n.d.). API Portfolio. (Internal Company Data). [8] Teva Pharmaceutical Industries Ltd. (n.d.). Global API Operations. (Internal Company Data). [9] Dr. Reddy's Laboratories. (n.d.). Active Pharmaceutical Ingredients. (Internal Company Data). [10] Lupin Limited. (n.d.). API Manufacturing Capabilities. (Internal Company Data). [11] Merck KGaA. (n.d.). Sigma-Aldrich Product Catalog. Retrieved from https://www.sigmaaldrich.com/ [12] Thermo Fisher Scientific. (n.d.). Laboratory Products and Services. Retrieved from https://www.thermofisher.com/ [13] Santa Cruz Biotechnology. (n.d.). Research Chemicals. Retrieved from https://www.scbt.com/ [14] Cayman Chemical. (n.d.). Research Tools and Reagents. Retrieved from https://www.caymanchem.com/