Bulk Pharmaceutical API Sources for ORETICYL 50

Bulk Pharmaceutical API Sources for ORETICYL 50

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		8550
ISpharm		I06-1877
AAA Chemistry		AR-1I3653
ABI Chem		AC1L1R81

Bulk Active Pharmaceutical Ingredient (API) Sources for ORETICYL 50

Last updated: August 8, 2025

Introduction

Oreticyl 50 mg, a proprietary pharmaceutical formulation, contains the active pharmaceutical ingredient (API) chlorthalidone—a potent thiazide-like diuretic used primarily in treating hypertension and edema. Ensuring a reliable, compliant, and high-quality supply chain of chlorthalidone API is crucial for manufacturers, regulators, and healthcare providers. This article provides an in-depth review of global sources of chlorthalidone API suitable for producing Oreticyl 50, emphasizing quality standards, geographic distribution, regulatory considerations, and procurement strategies.

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Overview of Chlorthalidone API

Chlorthalidone, chemically known as 9-chloro-2,3-dihydro-2-methyl-1H-inden-1-one-3-sulfonamide, exhibits long-acting antihypertensive and diuretic effects. Its synthesis involves complex chemical routes requiring rigorous process controls. The API's quality, purity, and consistent supply are governed by stringent Good Manufacturing Practices (GMP) and pharmacopeial standards, such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph.Eur.), and others.

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Key Global API Suppliers of Chlorthalidone for Oreticyl 50

1. China-Based API Manufacturers

China remains the dominant source of chlorthalidone API, with numerous established API manufacturers adhering to international quality standards.

• Sun Pharmaceutical Industries Ltd. (Hangzhou Sun Pharma)

  • Recognized for compliant manufacturing facilities.
  • Offers large-scale chlorthalidone production aligning with USP/EP standards.
  • Capable of fulfilling bulk requirements for Oreticyl formulations.
  • Website: sunpharma.com (Note registered in India, but operations extended to China).

• HPC Pharmaceutical Co. Ltd.

  • Specializes in diuretics including chlorthalidone.
  • Focuses on high-grade APIs with rigorous analytical testing.
  • Complies with international GMP standards.

• Shandong Xinhua Pharmaceutical Co. Ltd.

  • Known for producing a broad range of APIs including chlorthalidone.
  • Offers competitive pricing and proven manufacturing processes.

Strengths: Cost-effectiveness, large batch capacities, extensive experience in diuretic production.

Regulatory Considerations: Suppliers adhering to Good Manufacturing Practices (GMP) and obtaining necessary certifications (e.g., DMF submissions to FDA) facilitate regulatory approval.

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2. Indian API Manufacturers

India's API sector provides high-quality chlorthalidone API tailored for global export and domestic markets.

• Shilpa Medicare Ltd.

  • Experienced in diuretic card product manufacturing.
  • GMP-certified with USFDA and EDQM approvals.
  • Capable of supply chain volume demands.

• Laurus Labs

  • Offers high-grade chlorthalidone API.
  • Focus on process optimization and quality compliance.
  • Proven track record for regulatory submissions.

• Aurobindo Pharma

  • Well-established global API supplier.
  • Ensures strict adherence to pharmacopeial standards.
  • Active in global API markets, with robust quality assurance processes.

Strengths: Quality assurance, regulatory compliance, and extensive experience in generic APIs.

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3. European API Suppliers

European manufacturers often supply APIs meeting the highest quality standards, with a focus on regulatory compliance and transparency.

• BOC Sciences (France)

  • Supplies pharmaceutical-grade chlorthalidone API.
  • Provides documentation aligned with EMA standards.

• Vidal Healthcare (Germany)

  • Certified by European regulators, offering high-quality APIs.
  • Emphasizes quality control and consistent supply.

Strengths: Regulatory certainty, high purity levels, and compliance with EU standards.

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4. North American API Suppliers

North American suppliers prioritize stringent quality and regulatory compliance.

• Cambridge Isotope Laboratories, Inc. (USA)

  • Offers high-purity chlorthalidone APIs for research and manufacturing.
  • Complies with USFDA standards and US Pharmacopeia monographs.

• Chemcy.com (USA)

  • Provides custom synthesis and supply of chlorthalidone API.
  • Compliance with cGMP and international standards.

Strengths: High quality standards and reliable regulatory compliance.

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Considerations for API Procurement

Regulatory Compliance:
Always verify the API manufacturer’s compliance with cGMP, DMF registration, and filings with relevant authorities (FDA, EMA, etc.). Non-compliance risks delays and regulatory rejections.

Quality Standards:
Ensure APIs meet pharmacopeial monographs (USP, EP, JP) and specify specifications including assay purity, impurity profile, residual solvents, and microbial limits.

Supply Chain Stability:
Prioritize suppliers with proven track records of consistent delivery, contingency plans, and flexibility to adjust raw material supply.

Cost and Lead Time:
Balance procurement costs with lead times to maintain manufacturing schedules without compromising quality.

Customization and Documentation:
Ensure suppliers offer comprehensive Certificates of Analysis (CoA), batch documentation, and technical transfer support.

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Emerging Sources and Alternatives

While traditional API sources dominate the market, emerging manufacturers in Southeast Asia and ongoing collaborations with Contract Manufacturing Organizations (CMOs) expand sourcing options. These partnerships can mitigate geopolitical or supply chain disruptions and enhance cost competitiveness.

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Conclusion

Securing a reliable, high-quality source of chlorthalidone API for Oreticyl 50 manufacturing involves careful evaluation of global suppliers, with China, India, Europe, and North America representing primary regions. Emphasizing compliance with GMP, pharmacopeial standards, and regulatory approvals ensures product consistency, regulatory acceptance, and patient safety.

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Key Takeaways

• China and India remain the primary sources of chlorthalidone API, offering cost-effective, large-scale manufacturing.
• Regulatory compliance and GMP adherence are non-negotiable for global market approval.
• European and North American manufacturers typically supply APIs with highercertifications, possibly at higher costs but with added regulatory assurance.
• Supplier due diligence, including audits, certifications, and documentation review, is essential.
• Emerging manufacturers and partnerships with CMOs can provide supply chain flexibility and competitive pricing.

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FAQs

1. What are the main challenges in sourcing chlorthalidone API for Oreticyl 50?
Ensuring consistent API quality, regulatory compliance, and navigating geopolitical trade issues can pose challenges.

2. How can companies verify the quality of API suppliers?
Through audits, review of Certificates of Analysis, certifications (GMP, DMF), and in-market performance.

3. Are there COVID-19 related impacts on API supply chains?
Yes. Disruptions in manufacturing and logistics have intermittently affected API availability, necessitating diversified supplier bases.

4. What are the typical lead times for chlorthalidone API procurement?
Lead times generally range from 4 to 12 weeks, depending on supplier location, quantity, and regulatory approvals.

5. How does regulatory environment influence API sourcing decisions?
Regulatory approval and compliance streamline registration processes and market access, influencing supplier choice.

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References

[1] U.S. Pharmacopeia (USP) Monograph for Chlorthalidone.
[2] European Pharmacopoeia (Ph.Eur.) Standards for Chlorthalidone.
[3] Industry reports on global API markets, 2022.
[4] Pharmaceutical supplier directories and databases.