Suppliers and packagers for ALDACTAZIDE

ALDACTAZIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	ALDACTAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	012616	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-188-02	100 TABLET, FILM COATED in 1 BOTTLE (66993-188-02)	2021-11-29

Aldactazide Drug Suppliers and Manufacturing Landscape

Last updated: February 19, 2026

This analysis details the current landscape of Aldactazide suppliers, focusing on key active pharmaceutical ingredient (API) manufacturers and contract manufacturing organizations (CMOs) involved in its production. The data presented informs strategic decisions regarding supply chain stability, cost optimization, and potential partnership opportunities.

Who are the Primary API Suppliers for Aldactazide?

The active pharmaceutical ingredients for Aldactazide are spironolactone and hydrochlorothiazide. Global API manufacturers specializing in these compounds are critical to the Aldactazide supply chain.

• Spironolactone API Manufacturers:

  • China: Several Chinese manufacturers are significant suppliers of spironolactone API. These include companies like Hubei Xinqiao Pharmaceutical Co., Ltd., Jiangsu Yangzijiang Pharmaceutical Group Ltd., and Zhejiang NHU Co., Ltd. These entities often compete on price and volume.
  • India: Indian API producers, such as Sun Pharmaceutical Industries Ltd. and Dr. Reddy's Laboratories Ltd., are also prominent suppliers, known for their regulatory compliance and established global distribution networks.
  • Europe: While less dominant in volume compared to Asia, some European manufacturers, like Sanofi S.A. (historically, though their API production footprint has shifted), have produced spironolactone.

• Hydrochlorothiazide API Manufacturers:

  • India: India is a major hub for hydrochlorothiazide API production. Companies like Laurus Labs Limited, Divi's Laboratories Limited, and Aarti Industries Limited are key players.
  • China: Similar to spironolactone, Chinese manufacturers such as Anhui Jiujiang Pharmaceutical Co., Ltd. and Shaanxi Huisui Bio-Technology Co., Ltd. contribute significantly to the global supply.
  • Europe: Some European chemical companies may also supply hydrochlorothiazide, often for highly regulated markets.

Table 1: Key Spironolactone API Suppliers (Representative List)

Company Name	Country of Origin	Primary Region of Supply	Regulatory Approvals (Examples)
Hubei Xinqiao Pharmaceutical Co., Ltd.	China	Asia, Global	CFDA, potentially others
Jiangsu Yangzijiang Pharma. Group Ltd.	China	Asia, Global	CFDA, potentially others
Zhejiang NHU Co., Ltd.	China	Asia, Global	CFDA, potentially others
Sun Pharmaceutical Industries Ltd.	India	Global	US FDA, EMA, WHO
Dr. Reddy's Laboratories Ltd.	India	Global	US FDA, EMA, WHO

Table 2: Key Hydrochlorothiazide API Suppliers (Representative List)

Company Name	Country of Origin	Primary Region of Supply	Regulatory Approvals (Examples)
Laurus Labs Limited	India	Global	US FDA, EMA, WHO
Divi's Laboratories Limited	India	Global	US FDA, EMA, WHO
Aarti Industries Limited	India	Global	US FDA, EMA, WHO
Anhui Jiujiang Pharma. Co., Ltd.	China	Asia, Global	CFDA, potentially others
Shaanxi Huisui Bio-Tech. Co., Ltd.	China	Asia, Global	CFDA, potentially others

Note: Availability and specific regulatory filings can change. Companies listed are examples of established API producers in these categories.

Which Contract Manufacturing Organizations (CMOs) Produce Aldactazide Formulations?

Aldactazide is a finished dosage form (FDF) drug, typically in tablet form. CMOs play a vital role in its manufacturing, taking API and formulating, tableting, packaging, and distributing the final product.

• Global CMO Landscape: The production of Aldactazide formulations is distributed globally, with significant manufacturing capacity in North America, Europe, India, and China.
• Key Players and Capabilities:
  • North America: Many generic drug manufacturers in the United States and Canada have in-house manufacturing capabilities or utilize CMOs. Companies like Catalent Pharma Solutions and Thermo Fisher Scientific (Patheon) offer broad formulation and manufacturing services that could encompass Aldactazide.
  • Europe: European CMOs, often with strong GMP compliance and access to EU markets, are also significant. Recipharm AB (Sweden) and Ipsen S.A. (France) have extensive formulation and packaging capabilities.
  • India: Indian CMOs are increasingly important, offering cost-effective manufacturing solutions. Companies such as Divi's Laboratories Limited (which also produces APIs) and Hetero Drugs Limited are major contract manufacturers for various dosage forms.
  • China: Chinese CMOs are also expanding their global reach, providing competitive manufacturing services.

Table 3: Representative CMOs with Relevant Formulation Capabilities

Company Name	Country of Origin	Services Offered (Relevant to Aldactazide)
Catalent Pharma Solutions	USA	Formulation, Tableting, Packaging, Analytical Services
Thermo Fisher Scientific (Patheon)	USA/Canada	Formulation, Tableting, Packaging, Blistering, Bulk Manufacturing
Recipharm AB	Sweden	Tableting, Coating, Blister Packaging, Bottle Filling
Ipsen S.A.	France	Contract Manufacturing (various dosage forms)
Divi's Laboratories Limited	India	Formulation, Tableting, Packaging (also API)
Hetero Drugs Limited	India	Formulation, Tableting, Packaging (large scale)

Note: Specific Aldactazide manufacturing contracts are often proprietary. Companies listed have the stated capabilities to undertake such projects.

What are the Key Regulatory Considerations for Aldactazide Suppliers?

Suppliers of both APIs and finished drug products for Aldactazide must adhere to stringent regulatory requirements to ensure product quality, safety, and efficacy.

• Good Manufacturing Practices (GMP): All manufacturing facilities must comply with current GMP standards mandated by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national authorities.
  • FDA GMP: 21 CFR Part 210 and 211.
  • EMA GMP: EudraLex Volume 4.
• Drug Master Files (DMFs): API manufacturers typically maintain DMFs (or equivalent dossiers like ASMF in Europe) with regulatory agencies. These contain detailed information about the manufacturing process, quality control, and stability of the API. Pharmaceutical companies manufacturing the finished product reference these DMFs in their drug applications.
• Abbreviated New Drug Applications (ANDAs) and Marketing Authorisation Applications (MAAs): CMOs and finished drug product manufacturers submit these applications to gain approval to market Aldactazide. These applications require data demonstrating bioequivalence to the reference product and comprehensive manufacturing information.
• Country-Specific Registrations: Suppliers must ensure compliance with the specific registration and importation requirements of each target market. This can include inspections, site audits, and specific documentation for each region.
• Impurity Profiling: Rigorous testing for impurities, including related substances and residual solvents, is critical. Regulatory agencies set strict limits for known and unknown impurities.
• Stability Testing: Comprehensive stability studies under various conditions (ICH guidelines) are required to establish the shelf-life and storage conditions for both API and the finished product.

What are the Trends and Challenges in the Aldactazide Supply Chain?

The supply chain for established drugs like Aldactazide faces evolving trends and persistent challenges.

• Consolidation in API Manufacturing: A significant portion of API production for spironolactone and hydrochlorothiazide is concentrated in India and China due to cost advantages and large-scale capabilities. This concentration can pose supply chain risks if not managed proactively.
• Increasing Regulatory Scrutiny: Global regulatory agencies are continuously enhancing their oversight, leading to more frequent inspections and stricter enforcement of GMP compliance. Suppliers must maintain robust quality management systems.
• Cost Pressures: The market for generic drugs is highly competitive, creating constant pressure on suppliers to reduce manufacturing costs while maintaining quality.
• Geopolitical and Supply Chain Disruptions: Events such as trade disputes, natural disasters, or global health crises (e.g., COVID-19 pandemic) can significantly disrupt the availability of raw materials and finished products. Diversification of supply sources is a key mitigation strategy.
• Intellectual Property (IP) Landscape: While Aldactazide is an older drug with expired primary patents, secondary patents related to specific formulations, processes, or impurity profiles can still influence market entry for new manufacturers.
• Demand Fluctuations: Changes in prescribing patterns, competitor product introductions, or public health initiatives can lead to unpredictable demand, requiring agile manufacturing and inventory management.
• Sustainability Initiatives: Increasing focus on environmental sustainability is leading to greater demand for greener manufacturing processes and responsible sourcing of raw materials.

What are the Key Takeaways for Business Professionals?

• Diversify API Sources: Relying on a single supplier or region for spironolactone or hydrochlorothiazide API presents significant risk. Engage with multiple qualified manufacturers in different geographic locations.
• Vet CMO Partners Thoroughly: Contract manufacturers for Aldactazide formulations must demonstrate consistent GMP compliance, reliable capacity, and a strong regulatory track record. Conduct site audits and review regulatory filings.
• Monitor Regulatory Changes: Stay abreast of evolving GMP requirements, impurity limits, and registration processes in key markets to ensure ongoing compliance.
• Strategic Sourcing for Cost and Resilience: Balance cost-effectiveness with supply chain resilience. Consider suppliers with strong quality systems and proven ability to manage disruptions.
• Proactive Quality Management: Implement robust quality agreements with suppliers and CMOs, including clear specifications, change control procedures, and dispute resolution mechanisms.

Frequently Asked Questions

1. What is the typical shelf life for Aldactazide API and finished product? The shelf life for both spironolactone and hydrochlorothiazide APIs, when stored under recommended conditions, typically ranges from 3 to 5 years. For finished Aldactazide tablets, the shelf life is usually between 2 to 4 years, dependent on packaging and specific formulation stability data approved by regulatory agencies.
2. Are there any significant single-source APIs critical for Aldactazide manufacturing? Both spironolactone and hydrochlorothiazide are widely manufactured by multiple companies. While specific supply chain vulnerabilities can arise for individual brands or products due to contract manufacturing arrangements, there are generally multiple global sources for these APIs, mitigating the risk of a single-source dependency for the drug substance itself.
3. What are the main quality risks associated with Aldactazide API sourcing? Key quality risks include the presence of related substance impurities (e.g., other steroid impurities for spironolactone), residual solvents from synthesis, and potential polymorphic variations affecting bioavailability. Ensuring suppliers have robust analytical testing and process control is paramount.
4. How does the origin of Aldactazide API (e.g., China vs. India) impact its regulatory acceptance in major markets like the US or EU? The origin of the API does not inherently determine regulatory acceptance; rather, the supplier's adherence to GMP standards and the quality of data submitted in their Drug Master File (DMF) are critical. Both Indian and Chinese API manufacturers supplying to the US and EU must have facilities inspected by the FDA and EMA, respectively, and their DMFs must meet the stringent requirements of these agencies.
5. What is the typical lead time for procuring large quantities of Aldactazide API from manufacturers? Lead times for large-volume API orders can range from 3 to 9 months. This duration accounts for manufacturing scheduling, quality control testing, batch release, and logistical arrangements. Factors like current market demand, supplier capacity, and the complexity of the manufacturing process can influence this timeframe.

---

Citations

[1] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 210 – Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general. Retrieved from [Federal Register Website] [2] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 211 – Current good manufacturing practice for finished pharmaceuticals. Retrieved from [Federal Register Website] [3] European Medicines Agency. (n.d.). EudraLex Volume 4 – Good manufacturing practice. Retrieved from [EMA Website] [4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from [ICH Website]