Suppliers and packagers for generic pharmaceutical drug: FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	079245	ANDA	Aurobindo Pharma Limited	65862-308-01	100 TABLET in 1 BOTTLE (65862-308-01)	2009-07-09
Aurobindo Pharma	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	079245	ANDA	Aurobindo Pharma Limited	65862-308-30	30 TABLET in 1 BOTTLE (65862-308-30)	2009-07-09
Aurobindo Pharma	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	079245	ANDA	Aurobindo Pharma Limited	65862-308-99	1000 TABLET in 1 BOTTLE (65862-308-99)	2009-07-09
Aurobindo Pharma	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	079245	ANDA	Aurobindo Pharma Limited	65862-309-01	100 TABLET in 1 BOTTLE (65862-309-01)	2009-07-09
Aurobindo Pharma	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	079245	ANDA	Aurobindo Pharma Limited	65862-309-30	30 TABLET in 1 BOTTLE (65862-309-30)	2009-07-09

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE API & Finished Dose Manufacturing Landscape

Last updated: February 19, 2026

The global supply chain for Fosinopril Sodium; Hydrochlorothiazide (HCl) drug product involves multiple active pharmaceutical ingredient (API) manufacturers and finished dosage form (FDF) producers. Key API suppliers for Fosinopril Sodium include those in China and India, with established production capacities and regulatory filings. Hydrochlorothiazide, a widely produced diuretic, has a broad supplier base, also concentrated in India and China. Finished dosage form manufacturing is distributed across North America, Europe, and Asia, with contract manufacturing organizations (CMOs) playing a significant role.

Who Are the Primary Manufacturers of Fosinopril Sodium API?

Key manufacturers of Fosinopril Sodium API operate primarily in Asia, leveraging cost-competitive production and established expertise in complex organic synthesis.

• China-based Suppliers: Several Chinese companies have a significant presence in Fosinopril Sodium API production. These entities often possess large-scale manufacturing facilities and hold numerous regulatory certifications, including Drug Master Files (DMFs) submitted to the U.S. Food and Drug Administration (FDA) and European Directorate for the Quality of Medicines & HealthCare (EDQM) certificates of suitability. Companies like Zhejiang Huahai Pharmaceutical Co., Ltd. and Teva Pharmaceutical Industries Ltd. (through its Chinese manufacturing sites) are known players. Production capacity figures are not publicly disclosed but are estimated to be substantial, catering to both domestic and international markets.
• India-based Suppliers: India is another major hub for Fosinopril Sodium API manufacturing. Indian pharmaceutical companies benefit from skilled labor, established regulatory infrastructure, and a strong export orientation. Manufacturers such as Laurus Labs Limited and Divi's Laboratories Limited are recognized for their capabilities in producing a wide range of APIs, including complex molecules like Fosinopril Sodium. These companies often invest heavily in process optimization and quality control to meet global pharmaceutical standards.
• European and North American Manufacturers: While production is concentrated in Asia, some Western pharmaceutical companies or their contract manufacturers may also produce Fosinopril Sodium API, often for captive use or specialized markets. However, the volume from these regions is generally lower compared to Asian manufacturers due to cost considerations.

What is the Supplier Base for Hydrochlorothiazide API?

Hydrochlorothiazide (HCTZ) is a high-volume, well-established diuretic with a broad and competitive global supply base.

• Dominance of Indian and Chinese Manufacturers: The vast majority of global HCTZ API production is located in India and China. These countries offer significant cost advantages and have scaled their manufacturing capabilities to meet global demand. Key Indian suppliers include Sun Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories Ltd., and Aurobindo Pharma Limited. In China, companies such as Jiangsu HEC Pharmaceutical Co., Ltd. and Zhejiang Medicine Co., Ltd. are prominent producers.
• Regulatory Approvals and Quality Standards: Manufacturers of HCTZ API typically hold multiple regulatory approvals, including U.S. FDA DMFs, EDQM CEPs, and certifications from other national regulatory agencies. This widespread availability of regulatory documentation facilitates its use by generic drug manufacturers worldwide.
• Diversified Applications: HCTZ is not only used in combination with Fosinopril but also as a standalone therapy and in numerous other fixed-dose combination products, contributing to its consistently high production volumes.

Which Companies Manufacture Fosinopril Sodium; Hydrochlorothiazide Finished Dosage Forms (FDFs)?

The manufacturing of Fosinopril Sodium; Hydrochlorothiazide tablets involves FDF producers who source APIs from specialized manufacturers and formulate them into the final drug product.

• Branded Product Manufacturer: The originator product, Monopril-HCT (Fosinopril Sodium; Hydrochlorothiazide), was originally marketed by Bristol-Myers Squibb. While the originator may continue to have manufacturing operations, the market is now largely dominated by generic versions.
• Generic Manufacturers and CMOs: Numerous generic pharmaceutical companies worldwide produce Fosinopril Sodium; Hydrochlorothiazide tablets. These include:
  • North America: Companies such as Teva Pharmaceuticals USA, Inc., Apotex Corp., Lannett Company, Inc., and Hikma Pharmaceuticals (through its U.S. operations) have historically manufactured or currently manufacture this product. Many of these rely on contract manufacturing organizations (CMOs) for a portion of their production.
  • Europe: Major generic players like Sanofi (through its generics division), Accord Healthcare Ltd., and Gedeon Richter Plc. may produce the drug product for various European markets.
  • Asia: Companies in India and China, beyond API production, also have FDF manufacturing capabilities and export to global markets. Sun Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories Ltd., and Zhejiang Huahai Pharmaceutical Co., Ltd. are examples of companies that may produce finished dosage forms.
• Contract Manufacturing Organizations (CMOs): A significant portion of Fosinopril Sodium; Hydrochlorothiazide FDF manufacturing is outsourced to CMOs. These specialized facilities offer formulation, tableting, packaging, and regulatory support services. Companies like Catalent Pharma Solutions, Thermo Fisher Scientific (Patheon), and Recipharm AB are examples of large CMOs that could be involved in the production of such combination therapies. The choice of CMO often depends on geographic market, regulatory requirements, and scale of production.

What are the Key Regulatory Considerations for Fosinopril Sodium; Hydrochlorothiazide Supply Chains?

Regulatory compliance is paramount for ensuring the quality, safety, and efficacy of Fosinopril Sodium; Hydrochlorothiazide drug products.

• API Registration and Approval:
  • U.S. FDA: API manufacturers must file Drug Master Files (DMFs) with the U.S. FDA. These confidential documents detail the chemistry, manufacturing, and controls (CMC) of the API. Finished product manufacturers reference these DMFs in their Abbreviated New Drug Applications (ANDAs) or New Drug Applications (NDAs).
  • European Directorate for the Quality of Medicines & HealthCare (EDQM): Manufacturers can obtain Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) from the EDQM. A CEP confirms that the API complies with the relevant European Pharmacopoeia monograph and simplifies the regulatory submission process for FDF manufacturers in Europe.
  • Other National Agencies: Regulatory bodies in countries like Canada (Health Canada), Japan (PMDA), and Australia (TGA) have their own requirements for API registration and approval.
• Finished Dosage Form (FDF) Approval:
  • ANDA/NDA Filings (U.S.): Generic versions require ANDAs, which demonstrate bioequivalence to the reference listed drug (RLD). Branded versions require NDAs. Both include extensive CMC data, preclinical, and clinical study results.
  • Marketing Authorisation Applications (MAA) (Europe): FDFs require MAAs submitted to the European Medicines Agency (EMA) or national competent authorities, demonstrating quality, safety, and efficacy.
  • Good Manufacturing Practices (GMP): All manufacturing facilities, for both APIs and FDFs, must adhere to current GMP standards. Regular inspections by regulatory authorities (FDA, EMA, etc.) ensure ongoing compliance.
• Supply Chain Integrity and Traceability:
  • Serialization and Track-and-Trace: Regulations like the U.S. Drug Supply Chain Security Act (DSCSA) and the EU Falsified Medicines Directive (FMD) mandate serialization and track-and-trace capabilities throughout the supply chain to prevent counterfeit medicines from entering the market.
  • Supplier Qualification: FDF manufacturers must rigorously qualify and audit their API suppliers to ensure consistent quality and compliance. This includes assessing the supplier's GMP status, regulatory history, and supply chain security measures.
• Pharmacopoeial Compliance: APIs and finished products must meet the specifications outlined in relevant pharmacopoeias, such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP).

What Are the Market Dynamics and Trends Affecting Fosinopril Sodium; Hydrochlorothiazide?

The market for Fosinopril Sodium; Hydrochlorothiazide is influenced by several factors typical of established generic combination therapies.

• Generic Competition: The primary dynamic is intense generic competition. With patent expiries of the originator product, numerous generic manufacturers have entered the market, leading to significant price erosion. This drives a focus on cost-efficient API sourcing and manufacturing.
• Demand for Fixed-Dose Combinations (FDCs): FDCs like Fosinopril Sodium; Hydrochlorothiazide offer patient convenience by reducing the number of pills to take, improving adherence. This trend continues to support demand for such combination products.
• API Sourcing Strategy: Pharmaceutical companies often adopt multi-sourcing strategies for APIs to mitigate supply chain risks and negotiate better pricing. This involves qualifying multiple suppliers for both Fosinopril Sodium and Hydrochlorothiazide.
• Geographic Market Penetration: While North America and Europe remain significant markets, there is growing demand in emerging markets in Asia, Latin America, and Africa, driven by increasing healthcare access and the prevalence of cardiovascular diseases.
• Regulatory Scrutiny and Quality Control: Increased regulatory oversight worldwide means that manufacturers must maintain high standards of quality and compliance. Any supply chain disruption due to quality issues or regulatory non-compliance can have severe commercial consequences.
• Consolidation and CMO Dominance: The pharmaceutical manufacturing sector, including CMOs, has seen consolidation. Larger CMOs can offer integrated services and economies of scale, making them attractive partners for both branded and generic companies.

Key Takeaways

The supply chain for Fosinopril Sodium; Hydrochlorothiazide is characterized by a global distribution of API manufacturing, predominantly in China and India, alongside a dispersed FDF manufacturing base utilizing both in-house facilities and contract manufacturing organizations. Regulatory compliance, particularly regarding API registration (DMFs, CEPs) and GMP standards, is critical for all participants. The market is driven by generic competition, favoring cost-efficient production and robust supply chain management to meet patient demand for this established fixed-dose combination therapy.

Frequently Asked Questions

1. What are the primary challenges in securing a reliable supply of Fosinopril Sodium API? Challenges include dependence on a limited number of large-scale manufacturers, potential for supply disruptions due to geopolitical factors or regulatory actions against manufacturing sites, and ensuring consistent quality across different batches and suppliers.

2. How do regulatory requirements for API manufacturers differ between the U.S. and Europe? In the U.S., API manufacturers file DMFs, which are reviewed by the FDA in conjunction with the FDF applicant's ANDA or NDA. In Europe, manufacturers can obtain CEPs from the EDQM, which directly attests to compliance with pharmacopoeial standards and simplifies MAA submissions.

3. What role do contract manufacturing organizations (CMOs) play in the Fosinopril Sodium; Hydrochlorothiazide FDF market? CMOs are crucial for FDF production, offering specialized formulation, tableting, packaging, and regulatory support. They allow both generic and smaller branded companies to access manufacturing capacity without significant capital investment in their own facilities, and enable larger companies to manage fluctuating demand or outsource specific production lines.

4. Are there significant differences in quality standards between API suppliers from China and India? Both China and India have a significant number of API manufacturers that meet international quality standards (cGMP). However, regulatory scrutiny and enforcement can vary. Companies seeking supply from these regions must conduct thorough due diligence, including on-site audits and review of regulatory inspection reports, to ensure compliance with their target market requirements.

5. What are the typical shelf-life and storage conditions for Fosinopril Sodium; Hydrochlorothiazide tablets? Typical shelf-life for Fosinopril Sodium; Hydrochlorothiazide tablets is 24 months when stored at controlled room temperature (e.g., 20°C to 25°C or 68°F to 77°F), protected from light and moisture. Specific product labeling should always be consulted for exact storage requirements.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/development-approval-process-drugs/drug-master-files-dmfs [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificates of Suitability. Retrieved from https://www.edqm.eu/en/certificates-suitability [3] Drug Supply Chain Security Act (DSCSA). (n.d.). U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa [4] Falsified Medicines Directive. (n.d.). European Medicines Agency. Retrieved from https://www.ema.europa.eu/en/documents/legislative-summary/falsified-medicines-directive-201162eu-directive-200183ec-amended-directive-201162eu_en.pdf [5] United States Pharmacopeia. (n.d.). General Notices. In United States Pharmacopeia and National Formulary.