Bulk Pharmaceutical API Sources for ATACAND HCT

Bulk Pharmaceutical API Sources for ATACAND HCT

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-9C02091
RR Scientific		R6230327

Bulk Active Pharmaceutical Ingredient (API) Sources for ATACAND HCT

Last updated: July 28, 2025

Overview of ATACAND HCT

ATACAND HCT (candesartan cilexetil and hydrochlorothiazide) is a combination medication widely prescribed for hypertension management. The therapeutic efficacy of ATACAND HCT hinges on the quality and reliability of its active pharmaceutical ingredients (APIs): candesartan cilexetil and hydrochlorothiazide. Ensuring access to high-quality bulk APIs is pivotal for pharmaceutical manufacturers aiming to produce consistent, efficacious, and regulatory-compliant formulations.

API Composition and Manufacturing Requirements

Candesartan Cilexetil

Candesartan cilexetil is an angiotensin II receptor blocker (ARB), primarily synthesized via multi-step chemical processes involving advanced organic synthesis, chiral resolution, and purification techniques. Its quality is critical given its systemic vasodilatory role and contribution to antihypertensive activity.

Hydrochlorothiazide

Hydrochlorothiazide, a thiazide diuretic, is manufactured through well-established chemical synthesis routes from chlorosulfonylurea derivatives. The API's quality is vital for predictable diuretic effects and safety profiles.

Regulatory Considerations

Manufacturers sourcing APIs for ATACAND HCT must adhere to Good Manufacturing Practices (GMP) as per the U.S. FDA, EMA, and other relevant authorities. Certifications, cGMP compliance, documentation, and stability data are mandatory for regulatory approval.

Global API Suppliers for Candesartan Cilexetil

1. Teva Pharmaceutical Industries Ltd.

Teva is a leading API producer with comprehensive facilities catering to ARBs, including candesartan cilexetil. Recognized for quality compliance and supply reliability, Teva’s APIs are approved across multiple regulatory jurisdictions (FDA, EMA, PMDA) and have robust GMP certifications.

2. Hetero Labs Ltd.

Hetero specializes in cardiovascular APIs, including candesartan cilexetil. Their manufacturing process emphasizes high purity, consistent lot-to-lot quality, and extensive quality assurance practices aligned with international GMP standards.

3. Zhejiang Hisoar Pharmaceutical Co., Ltd.

This Chinese API manufacturer offers candesartan cilexetil with competitive pricing and high regulatory compliance. They possess GMP and ISO certifications, and their APIs are utilized globally, particularly in emerging markets.

4. Zhejiang Jianxi Pharmaceutical Co., Ltd.

Jianxi provides GMP-compliant candesartan cilexetil APIs with a focus on stable supply and competitive pricing. Their facilities are inspected regularly by international regulatory bodies, ensuring compliance.

5. Synthesis and Quality Assurance

Top-tier suppliers employ advanced synthesis techniques involving asymmetric synthesis, chiral resolution, and rigorous purification to ensure enantiomeric purity and bioequivalence. Quality control includes HPLC, NMR, and residual solvent analysis to meet pharmacopeial standards.

Major Suppliers of Hydrochlorothiazide

1. Mylan N.V. (now part of Viatris)

Mylan offers high-purity hydrochlorothiazide APIs with extensive experience in manufacturing thiazide diuretics. Their APIs are registered in major markets, with certifications aligning with global GMP standards.

2. Solara Active Ingredients Ltd.

Specialized in diuretics, Solara delivers hydrochlorothiazide APIs with reliable supply chains, optimized synthetic routes, and strict quality control protocols suitable for high-volume formulations.

3. Zhejiang Hisoar Pharmaceutical Co., Ltd.

Alongside candesartan cilexetil, Zhejiang Hisoar supplies hydrochlorothiazide, maintaining GMP certification and offering cost-effective bulk APIs to global markets.

4. Zhejiang Hisun Pharmaceutical Co., Ltd.

Hisun manufactures hydrochlorothiazide with a focus on molecular purity and batch consistency, adhering to international regulatory guidelines.

5. AbbVie (formerly Abbott)

AbbVie's APIs are recognized for high quality, with rigorous testing and compliance with cGMP standards, ensuring safe and efficacious hydrochlorothiazide for combination therapies.

Key Considerations in Selecting API Suppliers

• Regulatory Compliance: Suppliers must hold current GMP certifications, with inspections validated by relevant agencies.
• Quality Control & Testing: Certificates of Analysis (CoA), stability data, and third-party testing should meet pharmacopeial standards.
• Supply Chain Reliability: Consistent production capacity and reliable logistics minimize risk of shortages.
• Pricing & Lead Times: Competitive pricing without compromising quality, with lead times aligned to manufacturing schedules.
• Transparency & Documentation: Clear documentation of synthesis routes, impurity profiles, and batch records facilitates regulatory review.

Emerging Trends and Market Dynamics

1. Increasing Adoption of Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource API manufacturing to CMOs specializing in high-potency APIs like candesartan cilexetil and hydrochlorothiazide, aiming for cost efficiencies and compliance.

2. Focus on API Purity and Impurities Profiling

Regulatory agencies increasingly mandate detailed impurity profiling, pushing suppliers toward advanced synthetic pathways and purification techniques.

3. Geopolitical Factors and Supply Chain Diversification

Global supply chain disruptions, especially amid geopolitical tensions and pandemics, emphasize the need for diversified sourcing strategies to mitigate risks associated with singular regional suppliers.

4. Regulatory Harmonization and Quality Standards

A push toward harmonization of global quality standards encourages suppliers to align with international cGMP regulations, facilitating easier market access.

Concluding Remarks

The procurement of high-quality bulk APIs for ATACAND HCT requires comprehensive due diligence. Leading suppliers such as Teva, Hetero, and Zhejiang-based manufacturers offer reliable sources for candesartan cilexetil, supported by stringent quality and regulatory standards. For hydrochlorothiazide, established players like Mylan/Viatris and Solara provide proven APIs with global acceptance.

Effective sourcing strategies combine regulatory compliance, quality assurance, supply chain reliability, and cost competitiveness. As the market evolves, partnership with reputable API manufacturers remains essential to ensure uninterrupted supply, regulatory success, and ultimately, patient safety.

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Key Takeaways

• Ensuring regulatory compliance and GMP certification is crucial when sourcing APIs for ATACAND HCT.
• Leading API suppliers include Teva, Hetero, Zhejiang Hisoar, and Mylan, offering reliable and high-purity materials.
• Diversification of sources helps mitigate supply chain risks amidst geopolitical and market fluctuations.
• Advanced synthesis and purification techniques enhance API quality and reduce impurities.
• Continuous monitoring of market trends and regulatory changes optimizes sourcing strategies.

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FAQs

1. What are the primary criteria for selecting an API supplier for ATACAND HCT?
Regulatory compliance, product quality, supply reliability, pricing, and transparency are key factors influencing supplier selection.

2. Are there regional differences in API quality standards?
Yes. While GMP standards are globally recognized, some regions may have varying inspection rigor. Suppliers certified by recognized authorities like FDA or EMA typically offer higher assurance.

3. How does supply chain diversification benefit pharmaceutical manufacturing?
Diversification reduces dependency on a single source, decreases risk of shortages, and improves resilience against geopolitical or logistical disruptions.

4. What quality attributes are assessed during API testing?
Purity, assay, residual solvents, chiral purity (for candesartan), impurity profile, microbiological purity, and stability parameters.

5. Can emerging manufacturers meet international quality standards for APIs?
Many emerging suppliers are investing in advanced manufacturing and quality assurance systems, achieving GMP certification and aligning with international standards, thus enabling global market access.

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References

1. U.S. Food & Drug Administration. Guidance for Industry: API Manufacturing. FDA, 2020.
2. European Medicines Agency. Guideline on the Requirements for the Chemical and Pharmaceutical Quality of Active Substances. EMA, 2017.
3. Global Data. API Market Report, 2022.
4. Company websites: Teva, Hetero, Zhejiang Hisoar, Mylan, Solara.