Bulk Pharmaceutical API Sources for dichlorphenamide

Bulk Pharmaceutical API Sources for dichlorphenamide

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-004-285-635
Amadis Chemical		A21072
TimTec		SBB058142
TimTec		ST51014977

Bulk Active Pharmaceutical Ingredient (API) Sources for Dichlorphenamide

Last updated: July 27, 2025

Introduction

Dichlorphenamide, a carbonic anhydrase inhibitor primarily used in the treatment of periodic paralysis and glaucoma, demands high-quality bulk Active Pharmaceutical Ingredient (API). Sourcing reliable suppliers for dichlorphenamide is crucial for pharmaceutical companies to ensure the drug’s safety, efficacy, and regulatory compliance. This compilation provides an in-depth overview of prominent suppliers, manufacturing regions, regulatory considerations, and evaluation criteria for sourcing dichlorphenamide bulk API.

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Overview of Dichlorphenamide

Dichlorphenamide is a synthetic organic compound with the chemical formula C_4H_2Cl_2KNO_3. It is marketed under brand names such as Keveyis and has historically been available through specialized chemical suppliers and contract manufacturing organizations (CMOs). The API is synthesized via complex chemical processes involving chlorination of phenamide derivatives, requiring stringent quality controls to meet pharmaceutical standards like USP, EP, or JP.

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Major API Manufacturing Regions

1. China

Chinese pharmaceutical and chemical manufacturers dominate the global API supply chain, including for dichlorphenamide. The country offers competitive pricing, large-scale manufacturing capabilities, and extensive experience with chemical syntheses. Notably, several Chinese firms have achieved GMP certification and ISO compliance, allowing export to regulated markets.

2. India

Indian API producers also supply dichlorphenamide, often emphasizing high-quality standards aligned with WHO-GMP and EMA regulations. India’s pharmaceutical industry benefits from cost advantages, regulatory expertise, and established export channels.

3. Europe and North America

While fewer European and North American manufacturers produce dichlorphenamide at scale, some CMOs and specialty chemical firms offer custom synthesis and high-purity APIs for clinical trials and limited commercial manufacturing. These suppliers usually have rigorous quality assurance protocols complying with ICH guidelines and are preferred for regulated markets.

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Key Suppliers of Dichlorphenamide API

1. Benchmark Chemical Suppliers

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Known for bulk pharmaceutical chemicals, including chlorinated amides; they might offer custom synthesis services for dichlorphenamide with GMP compliance.
• Hikal Ltd. (India): A significant player in custom synthesis, offering APIs for niche indications, including derivatives related to carbonic anhydrase inhibitors.
• Shenzhen Chengzhi Pharmaceutical Co., Ltd. (China): Specializes in organic chemicals explicitly for pharmaceutical use, with strict adherence to quality standards.

2. Contract Manufacturing Organizations (CMOs)

• PAT Chemicals (India): Provides custom API synthesis, including chlorinated derivatives, with a focus on high-purity requirements.
• Hovione (Portugal): Offers development and manufacturing services, including APIs with strict regulatory standards—potentially capable of large-scale synthesis of dichlorphenamide.
• Vetter Pharma International (Germany): Known for contract manufacturing of complex APIs under GMP conditions, preferred for highly regulated markets.

3. Specialized Chemical Brokers and Traders

• Alibaba Chemistry Suppliers: While common for research-grade chemicals, some verified suppliers can provide bulk API grades suitable for preclinical and early-phase trials.
• Pharmaceutical raw material suppliers: These often serve as middlemen sourcing from primary manufacturers, providing procurement flexibility.

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Regulatory Considerations

When sourcing dichlorphenamide API, compliance with pharmacopoeial standards (USP, EP, JP) is imperative. Suppliers with current Good Manufacturing Practice (GMP) certification ensure the API meets strict quality, potency, and purity specifications. Importantly, buyers must verify analytical data, Certificate of Analysis (CoA), stability testing, endotoxin, and residual solvent levels.

Furthermore, the API's compatibility with existing formulations and compliance documentation is necessary for regulatory approvals in the target markets, especially in the US (FDA), Europe (EMA), and Japan (PMDA).

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Evaluation Criteria for API Suppliers

• Regulatory Certification: GMP, ISO, and IP certifications.
• Quality Control: Validation of analytical methods, impurity profiles, and batch consistency.
• Manufacturing Capacity: Ability to supply sufficient quantities on time.
• Cost Structure: Competitive pricing aligned with quality standards.
• Supply Chain Transparency: Traceability, documentation, and export history.
• Technical Support: Availability of documentation, samples, and process development.

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Supply Chain Challenges & Solutions

• Limited Availability: Due to the niche nature of dichlorphenamide, few suppliers produce it at scale. Establishing direct relationships or engaging CMOs can mitigate supply shortages.
• Regulatory Variability: Ensuring supplier compliance with regulatory standards minimizes approval delays.
• Quality Assurance: Ongoing audits and independent testing are essential to maintaining API integrity.

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Emerging Trends in API Sourcing

• Increased reliance on China and India due to cost advantages.
• Growth in custom synthesis services for rare or complex APIs.
• Shift towards vertically integrated CMOs offering both synthesis and formulation support for seamless supply.

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Conclusion

The sourcing landscape for dichlorphenamide API centers around China and India, with select European and North American CMOs offering high-quality options for regulated markets. Ensuring supplier compliance with GMP standards, maintaining rigorous quality assessments, and establishing transparent supply chains are pivotal to successful procurement. As demand for niche therapeutics like dichlorphenamide grows, strategic partnerships with experienced, compliant manufacturers will be vital for sustained supply.

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Key Takeaways

• Identify certified suppliers with GMP/ISO accreditation in China, India, and Europe for reliable, compliant API procurement.
• Prioritize quality control by reviewing analytical data, impurity profiles, and stability reports.
• Evaluate suppliers’ capacity for bulk production, delivery timelines, and regulatory support.
• Leverage custom synthesis services for niche APIs like dichlorphenamide, especially when standard suppliers cannot meet demand.
• Establish long-term partnerships with trusted API manufacturers to ensure consistent supply and regulatory compliance.

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FAQs

1. Is dichlorphenamide readily available from global suppliers?
Due to its niche application and complex synthesis, dichlorphenamide is not abundantly available from global suppliers. Most sourcing occurs through specialized chemical manufacturers in China and India, with limited availability in Europe and North America.

2. What quality standards should I verify when sourcing dichlorphenamide API?
Ensure the supplier provides GMP-compliant production, Certificates of Analysis (CoA), and assures meets pharmacopoeial specifications (USP, EP, JP). Confirm impurity profiles, residual solvent levels, and endotoxin testing.

3. Are there regulatory hurdles associated with importing dichlorphenamide API?
Yes. Import regulations vary by jurisdiction. Suppliers with GMP certification and comprehensive documentation facilitate smoother regulatory approval processes.

4. Can I co-develop custom synthesis routes for dichlorphenamide?
Yes. Many CMOs offer contract development and manufacturing services, enabling tailored synthesis pathways to optimize yield, quality, and cost.

5. What cost considerations should influence API sourcing decisions?
While cost is a significant factor, it should not compromise quality or regulatory compliance. Balancing affordability with supplier reliability and quality assurance is critical to avoid costly delays or product recalls.

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Sources:

1. [1] U.S. Pharmacopeia (USP) Monograph Database
2. [2] European Pharmacopoeia (EP) Documents
3. [3] Chinese Pharmacopoeia (ChP) Listings
4. [4] Indian Pharmacopoeia (IP) Standards
5. [5] Industry Reports on API Market Trends (e.g., IQVIA, EvaluatePharma)