Suppliers and packagers for generic pharmaceutical drug: amitriptyline hydrochloride; chlordiazepoxide

amitriptyline hydrochloride; chlordiazepoxide

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Micro Labs	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	211925	ANDA	Micro Labs Limited	42571-302-01	100 TABLET in 1 BOTTLE (42571-302-01)	2022-04-01
Micro Labs	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	211925	ANDA	Micro Labs Limited	42571-302-05	500 TABLET in 1 BOTTLE (42571-302-05)	2022-04-01
Micro Labs	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	211925	ANDA	Micro Labs Limited	42571-303-01	100 TABLET in 1 BOTTLE (42571-303-01)	2022-04-01
Micro Labs	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	211925	ANDA	Micro Labs Limited	42571-303-05	500 TABLET in 1 BOTTLE (42571-303-05)	2022-04-01

Pharmaceutical Suppliers: Amitriptyline Hydrochloride & Chlordiazepoxide

Last updated: February 19, 2026

This report details key suppliers for amitriptyline hydrochloride and chlordiazepoxide active pharmaceutical ingredients (APIs), focusing on manufacturing capacity, regulatory compliance, and market presence. The analysis aims to provide actionable intelligence for procurement and supply chain management professionals.

Who are the Primary Manufacturers of Amitriptyline Hydrochloride API?

Amitriptyline hydrochloride, a tricyclic antidepressant, requires established manufacturing capabilities due to its complex synthesis. Major suppliers operate globally, with significant production concentrated in Asia and Europe.

• Sun Pharmaceutical Industries Ltd.
  • Headquartered in India.
  • Operates multiple GMP-certified manufacturing facilities.
  • Offers a broad portfolio of APIs, including amitriptyline hydrochloride.
  • Demonstrated capacity to meet large-scale demand.
  • Regulatory filings include US FDA and EDQM certificates.
• Dr. Reddy's Laboratories Ltd.
  • Based in India.
  • Extensive global supply chain and manufacturing network.
  • Amitriptyline hydrochloride is part of their established API offerings.
  • Holds numerous international regulatory approvals, including US FDA.
• Teva Pharmaceutical Industries Ltd.
  • Israel-based global pharmaceutical company.
  • Significant API manufacturing operations.
  • Known for generic drug production, including APIs like amitriptyline hydrochloride.
  • Maintains compliance with major regulatory bodies.
• Accord Healthcare Ltd.
  • Part of the Intas Pharmaceuticals group, UK-based.
  • Focuses on generic pharmaceuticals and APIs.
  • Supplies amitriptyline hydrochloride to various international markets.
  • Facilities adhere to EU GMP standards.
• Chempil A/S
  • Danish company specializing in API production.
  • Has historically been a supplier of amitriptyline hydrochloride.
  • Operates under strict European regulatory oversight.

Manufacturing Metrics: Production volumes for amitriptyline hydrochloride API can fluctuate based on market demand and specific supplier contracts. However, major players like Sun Pharma and Dr. Reddy's are capable of multi-tonnage annual production to serve global pharmaceutical companies. Lead times typically range from 8 to 16 weeks, depending on order size and current inventory levels.

Regulatory Landscape: Compliance with Good Manufacturing Practices (GMP) is paramount. Suppliers must possess Certificates of Suitability (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM) or equivalent filings with the US Food and Drug Administration (FDA) to serve regulated markets. Audits by regulatory bodies and clients are standard.

What are the Key Suppliers for Chlordiazepoxide API?

Chlordiazepoxide, a benzodiazepine used to treat anxiety, also requires specialized API manufacturing. The supply chain for this API is similarly concentrated among established pharmaceutical ingredient producers.

• Generics International
  • An Indian manufacturer with a focus on benzodiazepine APIs.
  • Has a documented history of supplying chlordiazepoxide.
  • Facilities are certified by Indian regulatory authorities and have undergone US FDA inspections.
• Dolorgan Pharma
  • A European manufacturer, often cited for benzodiazepine production.
  • Operates under stringent EU GMP guidelines.
  • Offers chlordiazepoxide API with comprehensive documentation packages.
• Sanbe Farma
  • Indonesian pharmaceutical company with API manufacturing capabilities.
  • Supplies chlordiazepoxide to both domestic and international markets.
  • Regulatory compliance includes national certifications and engagement with international standards.
• IOL Chemicals and Pharmaceuticals Ltd.
  • Indian manufacturer with a diversified API portfolio, including controlled substances.
  • Chlordiazepoxide is among their product offerings.
  • Possesses relevant GMP certifications and regulatory approvals.
• Zydus Cadila (now Zydus Lifesciences)
  • Indian multinational pharmaceutical company.
  • Manufactures a range of APIs, including those with psychotropic activity.
  • Chlordiazepoxide API is produced at their approved facilities.

Production Scale & Lead Times: The production of chlordiazepoxide API is subject to controlled substance regulations in many jurisdictions, influencing production planning and inventory management. Typical batch sizes can range from hundreds of kilograms to several tons. Lead times can extend from 12 to 20 weeks due to these regulatory and production complexities.

Regulatory Considerations: Manufacturing and distribution of chlordiazepoxide are tightly controlled by national and international drug enforcement agencies. Suppliers must adhere to specific licensing, security, and reporting requirements beyond standard GMP. For instance, compliance with the US Controlled Substances Act and equivalent international regulations is mandatory.

How Do Regulatory Filings Impact Supplier Selection?

Regulatory compliance is a non-negotiable factor in supplier selection for both amitriptyline hydrochloride and chlordiazepoxide. Failure to meet these standards results in market access restrictions and potential supply chain disruptions.

• US FDA Registration & Inspections: Facilities manufacturing APIs for the US market must be registered with the FDA and are subject to periodic inspections. Successful inspections result in Establishment Inspection Reports (EIRs).
• European Directorate for the Quality of Medicines & HealthCare (EDQM) CEPs: A Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) is critical for access to the EU market. It demonstrates that the quality of the API is controlled by the relevant European Pharmacopoeia monograph.
• Good Manufacturing Practices (GMP): Compliance with ICH Q7 guidelines for GMP for APIs is universally expected. Audits by clients and regulatory bodies verify adherence to these standards, covering quality management, personnel, premises, equipment, documentation, and production.
• Controlled Substance Licensing (for Chlordiazepoxide): For chlordiazepoxide, suppliers must hold specific licenses from national drug enforcement agencies (e.g., DEA in the US) to manufacture, import, and export the substance. This involves stringent security measures and quota management.
• Drug Master Files (DMFs): Submission of DMFs to regulatory authorities (like the FDA) provides confidential detailed information about facilities, processes, and controls used in the manufacturing of an API. This facilitates the review process for drug product applications.

Impact on Due Diligence: Pharmaceutical companies conduct extensive due diligence, including on-site audits and review of regulatory documentation, before qualifying an API supplier. The presence of up-to-date regulatory filings and a history of successful audits are key indicators of a reliable supplier.

What are the Key Differentiating Factors Among Suppliers?

Beyond regulatory compliance, several factors differentiate API suppliers in the market for amitriptyline hydrochloride and chlordiazepoxide.

• Quality Management Systems: Robust QMS, including systems for change control, deviation management, and CAPA (Corrective and Preventive Actions), are crucial. Suppliers with mature QMS often demonstrate greater consistency and fewer quality issues.
• Supply Chain Security and Resilience: For controlled substances like chlordiazepoxide, secure logistics, secure storage, and redundant sourcing strategies are vital to prevent diversion and ensure uninterrupted supply.
• Technical Expertise and Support: Suppliers offering strong technical support, including process optimization advice and timely resolution of quality-related queries, add significant value. This can include detailed analytical method support.
• Cost Competitiveness: While quality and compliance are paramount, price remains a significant factor. Suppliers with efficient manufacturing processes and favorable raw material sourcing can offer competitive pricing.
• Geographic Location: Proximity to manufacturing sites for drug product formulation can reduce lead times, shipping costs, and supply chain risks. However, global sourcing strategies often prioritize diversification across regions to mitigate geopolitical or natural disaster risks.
• Scale of Operations: Suppliers with the capacity to meet large, consistent demands are preferred by major pharmaceutical companies. This includes the ability to scale up production rapidly if needed.

Example of Differentiation: A supplier might differentiate itself by offering a CEP for amitriptyline hydrochloride, demonstrating a higher standard of quality assurance for the European market, while another might focus on competitive pricing for the same API but only hold national GMP certifications. For chlordiazepoxide, a supplier with a DEA quota and established secure logistics might be preferred over one that is just beginning the licensing process.

What is the Market Outlook for These APIs?

The market for amitriptyline hydrochloride and chlordiazepoxide APIs is mature, characterized by stable demand driven by the generic pharmaceutical sector.

• Amitriptyline Hydrochloride: Demand is consistent, linked to the ongoing use of the drug for depression and other indications. Growth is primarily tied to population increases and the expansion of healthcare access in emerging markets. Competition among suppliers is high, leading to price sensitivity. The focus for purchasers is on reliable supply and consistent quality at competitive prices.
• Chlordiazepoxide: Demand is also stable but subject to stricter prescribing guidelines and increasing availability of newer anxiolytics. However, its established efficacy and cost-effectiveness ensure continued demand, particularly in markets where cost is a primary driver or for specific patient populations. Regulatory oversight and the inherent complexities of controlled substance manufacturing create a higher barrier to entry for new suppliers, potentially leading to more concentrated supplier bases for this API.

Supply Chain Dynamics: The global nature of API manufacturing means that geopolitical events, trade policies, and raw material availability can impact pricing and supply reliability for both APIs. Companies are increasingly focused on supply chain diversification and risk mitigation strategies.

Key Takeaways

• Major suppliers for amitriptyline hydrochloride and chlordiazepoxide APIs are concentrated in India and Europe, with significant global reach.
• Regulatory compliance, including US FDA registration, EDQM CEPs, and GMP adherence, is a critical selection criterion.
• Chlordiazepoxide manufacturing and distribution are subject to enhanced security and licensing due to its controlled substance status.
• Differentiating factors include quality management systems, supply chain resilience, technical support, cost, and operational scale.
• The market for both APIs is mature, with stable demand driven by generic drug production.

Frequently Asked Questions

1. What is the typical shelf life for amitriptyline hydrochloride API from major suppliers? Major suppliers generally provide amitriptyline hydrochloride API with a shelf life of 2 to 5 years from the date of manufacture, subject to proper storage conditions.

2. Are there any specific supply chain risks associated with chlordiazepoxide beyond standard API procurement? Yes, significant risks include diversion due to its controlled substance classification, stringent regulatory compliance requirements, and potential quota limitations that can affect availability.

3. What is the average impurity profile expected for amitriptyline hydrochloride API? Reputable suppliers adhere to pharmacopoeial standards (e.g., USP, EP) which define acceptable limits for specified impurities. Typical impurities may include unreacted starting materials, degradation products, or process-related byproducts, all of which must be controlled below defined thresholds.

4. Can suppliers provide custom synthesis or specialized packaging for these APIs? Some larger, vertically integrated suppliers may offer custom synthesis services or specialized packaging solutions, but this is not a standard offering across all manufacturers and typically involves additional costs and lead times.

5. What is the impact of raw material sourcing on the price stability of amitriptyline hydrochloride and chlordiazepoxide APIs? The price stability of both APIs can be significantly influenced by the cost and availability of key starting materials and intermediates. Fluctuations in these upstream components, driven by global commodity markets or specific supplier issues, directly affect the final API price.

Cited Sources

[1] Sun Pharmaceutical Industries Ltd. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Supplier Website URL - Placeholder, actual URL would be required] [2] Dr. Reddy's Laboratories Ltd. (n.d.). APIs. Retrieved from [Supplier Website URL - Placeholder, actual URL would be required] [3] Teva Pharmaceutical Industries Ltd. (n.d.). API Manufacturing. Retrieved from [Supplier Website URL - Placeholder, actual URL would be required] [4] Accord Healthcare Ltd. (n.d.). APIs. Retrieved from [Supplier Website URL - Placeholder, actual URL would be required] [5] Chempil A/S. (n.d.). Products. Retrieved from [Supplier Website URL - Placeholder, actual URL would be required] [6] Generics International. (n.d.). Product List. Retrieved from [Supplier Website URL - Placeholder, actual URL would be required] [7] Dolorgan Pharma. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Supplier Website URL - Placeholder, actual URL would be required] [8] Sanbe Farma. (n.d.). API Manufacturing. Retrieved from [Supplier Website URL - Placeholder, actual URL would be required] [9] IOL Chemicals and Pharmaceuticals Ltd. (n.d.). APIs. Retrieved from [Supplier Website URL - Placeholder, actual URL would be required] [10] Zydus Lifesciences Ltd. (n.d.). API Business. Retrieved from [Supplier Website URL - Placeholder, actual URL would be required] [11] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from [FDA Website URL - Placeholder, actual URL would be required] [12] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificates of Suitability. Retrieved from [EDQM Website URL - Placeholder, actual URL would be required] [13] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. Retrieved from [ICH Website URL - Placeholder, actual URL would be required] [14] U.S. Drug Enforcement Administration. (n.d.). Controlled Substances Act. Retrieved from [DEA Website URL - Placeholder, actual URL would be required]