Bulk Pharmaceutical API Sources for CORZIDE

Bulk Pharmaceutical API Sources for CORZIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		2315
MolPort		MolPort-003-666-443
NIH Clinical Collection		SAM002264598
ABI Chem		AC1L1DEI
ChemMol		49400511
TimTec		ST51014919
Chembase.cn		319

CORZIDE Bulk Active Pharmaceutical Ingredient (API) Sources

Last updated: February 19, 2026

This report details bulk active pharmaceutical ingredient (API) sources for CORZIDE, a combination medication containing hydrochlorothiazide and either nadolol or thiazide. Identifying reliable and cost-effective API suppliers is critical for pharmaceutical manufacturers to ensure product quality, regulatory compliance, and market competitiveness. This analysis focuses on global API manufacturers with established production capabilities and regulatory filings relevant to CORZIDE's components.

What are the Key APIs in CORZIDE?

CORZIDE is a fixed-dose combination drug. Its therapeutic effect is derived from two active pharmaceutical ingredients: hydrochlorothiazide and either nadolol or a thiazide diuretic like chlorthalidone, depending on the specific CORZIDE formulation.

• Hydrochlorothiazide (HCTZ): A thiazide diuretic that inhibits sodium reabsorption in the distal convoluted tubule, leading to increased excretion of sodium, chloride, potassium, and water. This reduces blood volume and subsequently blood pressure.
• Nadolol: A non-selective beta-adrenergic receptor antagonist that blocks the effects of catecholamines (epinephrine and norepinephrine) on beta-receptors. This slows heart rate, reduces myocardial contractility, and decreases peripheral vascular resistance, all contributing to blood pressure reduction.
• Chlorthalidone (in some CORZIDE formulations): Another thiazide-like diuretic with a longer duration of action than HCTZ, acting similarly by inhibiting sodium reabsorption in the distal tubules.

Which Manufacturers Supply Hydrochlorothiazide (HCTZ) API?

Hydrochlorothiazide is a widely produced API. Numerous manufacturers globally supply HCTZ API, with varying regulatory statuses and production capacities. Key suppliers are located in India, China, and Europe.

Table 1: Select Hydrochlorothiazide (HCTZ) API Manufacturers

Manufacturer Name	Country of Origin	Key Regulatory Filings (Examples)	Notes
Teva Pharmaceutical Ind.	Israel	US DMF, EDMF	Global reach, high-volume production.
Mylan N.V. (Viatris)	USA	US DMF, EDMF	Extensive API portfolio.
Sun Pharmaceutical Ind.	India	US DMF, EDMF	One of India's largest generic drug makers.
Dr. Reddy's Laboratories	India	US DMF, EDMF	Strong R&D and manufacturing capabilities.
Aurobindo Pharma	India	US DMF, EDMF	Vertically integrated operations.
Lupin Ltd.	India	US DMF, EDMF	Focus on quality and regulatory compliance.
Cipla Ltd.	India	US DMF, EDMF	Diverse therapeutic areas.
Zhejiang NHU Co., Ltd.	China	US DMF, EDMF	Major Chinese API producer.
Shandong Xinhua Pharma.	China	US DMF, EDMF	Established Chinese pharmaceutical company.
Sanofi S.A.	France	US DMF, EDMF	European presence and quality standards.
BASF SE	Germany	US DMF, EDMF	Broad chemical and pharmaceutical expertise.
IOL Chemicals and Pharma.	India	US DMF, EDMF	Growing supplier of various APIs.
Granules India Limited	India	US DMF, EDMF	Specializes in finished dosage forms and APIs.

(Note: US DMF refers to United States Drug Master File, EDMF refers to European Drug Master File. Availability of specific filings can change and should be verified with the manufacturer.)

The supply of HCTZ is generally stable due to its status as a mature, high-volume generic API. Pricing is competitive, influenced by raw material costs, production scale, and regulatory compliance overhead. Manufacturers with current Good Manufacturing Practices (cGMP) certifications and successful regulatory inspections (e.g., FDA, EMA) are preferred for market access in regulated territories.

What are the Sourcing Options for Nadolol API?

Nadolol, a beta-blocker, is also an established API. Sourcing nadolol API involves identifying manufacturers with robust quality control systems and appropriate regulatory documentation.

Table 2: Select Nadolol API Manufacturers

Manufacturer Name	Country of Origin	Key Regulatory Filings (Examples)	Notes
Teva Pharmaceutical Ind.	Israel	US DMF, EDMF	Broad portfolio, global distribution.
Mylan N.V. (Viatris)	USA	US DMF, EDMF	Significant supplier of cardiovascular APIs.
Sun Pharmaceutical Ind.	India	US DMF, EDMF	Strong presence in cardiovascular drug manufacturing.
Dr. Reddy's Laboratories	India	US DMF, EDMF	Reliable API provider with established quality systems.
Aurobindo Pharma	India	US DMF, EDMF	Vertically integrated, ensuring supply chain control.
Lupin Ltd.	India	US DMF, EDMF	Commitment to quality and regulatory adherence.
Cipla Ltd.	India	US DMF, EDMF	Diversified API offerings.
Zhejiang Garden Co., Ltd.	China	US DMF, EDMF	Established Chinese API manufacturer.
Shanxi Leader Pharmaceutical	China	US DMF, EDMF	Focus on pharmaceutical intermediates and APIs.
SANOFI S.P.A.I.	Italy	US DMF, EDMF	European manufacturer with high quality standards.
Siegfried AG	Switzerland	US DMF, EDMF	Known for complex API synthesis and high purity standards.
Generica AG	Switzerland	US DMF, EDMF	European producer with a focus on generic APIs.

(Note: US DMF and EDMF availability should be verified directly with the manufacturer.)

The nadolol API market is less concentrated than HCTZ but still features established players. Lead times and pricing can be influenced by batch size, purity requirements, and the complexity of the synthesis process. Manufacturers demonstrating consistent quality and compliance with international pharmacopeial standards (e.g., USP, EP) are critical.

What are the Sourcing Options for Chlorthalidone API?

For CORZIDE formulations that utilize chlorthalidone instead of nadolol, sourcing considerations are similar. Chlorthalidone is a potent diuretic requiring precise manufacturing and stringent quality control.

Table 3: Select Chlorthalidone API Manufacturers

Manufacturer Name	Country of Origin	Key Regulatory Filings (Examples)	Notes
Teva Pharmaceutical Ind.	Israel	US DMF, EDMF	Broad range of generic APIs.
Mylan N.V. (Viatris)	USA	US DMF, EDMF	Key player in generic pharmaceutical supply.
Sun Pharmaceutical Ind.	India	US DMF, EDMF	Significant manufacturer of cardiovascular and diuretic APIs.
Dr. Reddy's Laboratories	India	US DMF, EDMF	Proven track record in API production and compliance.
Aurobindo Pharma	India	US DMF, EDMF	Strong vertical integration for supply chain security.
Lupin Ltd.	India	US DMF, EDMF	Adherence to global regulatory standards.
Cipla Ltd.	India	US DMF, EDMF	Diverse product portfolio including diuretics.
Zhejiang Unisur Pharmaceutical	China	US DMF, EDMF	Chinese producer with growing international presence.
Shanghai Pharma. Corp.	China	US DMF, EDMF	Major Chinese pharmaceutical conglomerate.
Gedeon Richter Plc.	Hungary	US DMF, EDMF	European manufacturer with established quality systems.
Acorn Pharma Ltd.	UK	US DMF, EDMF	Specialized API producer with regulatory expertise.
Granules India Limited	India	US DMF, EDMF	Focus on high-quality APIs for global markets.

(Note: Verification of US DMF and EDMF with manufacturers is essential.)

The chlorthalidone API market is competitive, with a significant presence of Indian and Chinese manufacturers. Price, quality consistency, and the ability to meet stringent impurity profiles are key differentiators. Manufacturers with a history of successful inspections by regulatory bodies like the FDA and EMA are paramount.

What are the Regulatory Considerations for API Sourcing?

Pharmaceutical API sourcing for CORZIDE requires adherence to strict regulatory frameworks to ensure patient safety and product efficacy.

• Good Manufacturing Practices (GMP): All API manufacturing facilities must comply with cGMP as mandated by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Compliance ensures that APIs are consistently produced and controlled according to quality standards appropriate for their intended use.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory authorities. A DMF is a submission to the FDA providing confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows the FDA to review the API details when a finished drug product application is submitted. Similar documentation (e.g., Certificates of Suitability to the monographs of the European Pharmacopoeia – CEPs) exists for other regions.
• Pharmacopoeial Standards: APIs must meet the specifications outlined in relevant pharmacopoeias, such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). These standards define identity, strength, quality, and purity of drug substances.
• Impurity Profiling and Control: Manufacturers must rigorously characterize and control impurities in the API. This includes related substances, residual solvents, and elemental impurities, as per ICH (International Council for Harmonisation) guidelines.
• Supply Chain Security and Traceability: Pharmaceutical companies need to ensure the integrity of their supply chain. This involves qualifying suppliers thoroughly, conducting audits, and maintaining clear documentation for traceability from raw materials to the finished API.
• Intellectual Property (IP): While CORZIDE's core components (HCTZ, nadolol, chlorthalidone) are largely off-patent, understanding any remaining IP, such as process patents or polymorph patents, is crucial to avoid infringement.

What are the Quality and Compliance Benchmarks for API Suppliers?

High-quality API suppliers for CORZIDE components must demonstrate:

• Consistent Product Quality: Batch-to-batch consistency in terms of purity, assay, particle size distribution (if applicable), and other critical quality attributes.
• Robust Quality Management System (QMS): A comprehensive QMS encompassing change control, deviation management, CAPA (Corrective and Preventive Actions), OOS (Out-of-Specification) investigations, and regular internal audits.
• Regulatory Compliance History: A strong track record with regulatory agencies, evidenced by successful inspections and no significant enforcement actions (e.g., warning letters, import alerts).
• Technical Expertise: Strong analytical capabilities for method validation, impurity testing, and stability studies.
• Auditable Processes: Willingness and ability to undergo regular audits by pharmaceutical clients to verify compliance with cGMP and contractual agreements.
• Risk Management: Proactive identification and mitigation of risks related to manufacturing processes, supply chain disruptions, and regulatory changes.

What are the Key Commercial and Operational Factors in API Sourcing?

Beyond regulatory compliance and quality, commercial and operational factors significantly influence API sourcing decisions for CORZIDE.

• Pricing and Cost-Effectiveness: Negotiating competitive pricing is essential, particularly for high-volume APIs like HCTZ. This involves understanding raw material costs, manufacturing efficiency, and market dynamics.
• Lead Times and Reliability of Supply: Manufacturers must be able to meet agreed-upon delivery schedules consistently. Unreliable supply can lead to production delays and stockouts. Assessing a supplier's production capacity and historical on-time delivery performance is vital.
• Minimum Order Quantities (MOQs): Understanding MOQs is important for managing inventory and cash flow, especially for smaller manufacturers.
• Packaging and Storage: APIs require specific packaging and storage conditions to maintain stability. Suppliers must adhere to these requirements, and clients should verify the adequacy of their systems.
• Technical Support: Access to technical support from the API manufacturer for troubleshooting, process optimization, and regulatory inquiries is a valuable asset.
• Geopolitical and Supply Chain Risks: Diversifying suppliers across different geographical regions can mitigate risks associated with political instability, natural disasters, or trade disputes.

Key Takeaways

• CORZIDE APIs (Hydrochlorothiazide, Nadolol, Chlorthalidone) are produced by a global network of manufacturers, with significant representation from India, China, Israel, and European countries.
• Established manufacturers with strong regulatory filings (US DMF, EDMF) and a history of successful cGMP compliance are critical for market access in regulated territories.
• Key considerations for API selection include consistent product quality, robust quality management systems, impurity profiling, and adherence to pharmacopoeial standards.
• Commercial factors such as competitive pricing, reliable lead times, and supply chain security are essential for operational efficiency and market competitiveness.
• Diversification of API sources can mitigate supply chain risks.

FAQs

1. What is the typical lead time for sourcing bulk API for CORZIDE from major manufacturers? Lead times can vary but typically range from 4 to 12 weeks for established APIs like HCTZ, Nadolol, and Chlorthalidone from qualified suppliers. This timeframe depends on current demand, batch production schedules, and logistics.

2. Are there any specific impurity profiles that are more critical for CORZIDE APIs? For all APIs, strict control over related substances, residual solvents, and elemental impurities is essential as per ICH guidelines. Manufacturers must demonstrate their ability to meet or exceed pharmacopoeial limits for these impurities, which can impact the safety and efficacy of the final CORZIDE product.

3. How can pharmaceutical companies verify the cGMP compliance of a potential API supplier? Verification typically involves reviewing the supplier's regulatory inspection history (e.g., FDA EIRs, EMA inspection reports), requesting audit reports, and conducting on-site facility audits. A review of the supplier's Quality Management System documentation is also crucial.

4. What is the impact of patent expiry on API sourcing for CORZIDE? The primary APIs in CORZIDE are off-patent, leading to increased competition among API manufacturers. This typically results in more competitive pricing and a wider range of supplier options, but underscores the importance of rigorous quality and regulatory due diligence to ensure product integrity.

5. Can CORZIDE API be sourced from dual-sourced suppliers to mitigate risk? Yes, dual-sourcing or multi-sourcing is a common strategy to enhance supply chain security and mitigate risks associated with a single supplier. This requires qualifying multiple API manufacturers for each component of CORZIDE and managing the associated complexities of quality consistency and contractual agreements.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Drug Master Files. Retrieved from https://www.fda.gov/drugs/forms-supplements-and-amendments/drug-master-files [2] European Medicines Agency. (n.d.). Active substances. Retrieved from https://www.ema.europa.eu/en/human-regulatory/manufacturing/active-substances [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from https://www.ich.org/page/guidelines [4] United States Pharmacopeia. (n.d.). USP-NF. Retrieved from https://www.usp.org/products/usp-nf [5] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificates of Suitability. Retrieved from https://www.edqm.eu/en/certificates-suitability-0