Bulk Pharmaceutical API Sources for ETHMOZINE

Bulk Pharmaceutical API Sources for ETHMOZINE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemBridge		5229972
Molport		MolPort-000-917-706
Finetech Industry Limited		FT-0630550
Alfa Chemistry		29560-58-5

Bulk Active Pharmaceutical Ingredient (API) Sources for Ethmozine

Last updated: July 29, 2025

Introduction

Ethmozine, known chemically as promethazine, is a phenothiazine derivative widely used in medical settings for its antiemetic, antihistamine, sedative, and anti-allergic properties. Its applications span the treatment of nausea, allergies, motion sickness, and sedation. The global pharmaceutical industry relies on a robust supply chain of high-quality Active Pharmaceutical Ingredients (APIs) like Ethmozine to meet pharmaceutical manufacturing demands. Ensuring reliable API sourcing from reputable providers is critical for maintaining product integrity, regulatory compliance, and supply chain resilience.

This article examines key global API suppliers for Ethmozine, exploring their manufacturing capabilities, quality standards, geographical distribution, and implications for pharmaceutical companies seeking sustainable sourcing solutions.

Understanding Ethmozine (Promethazine) API

Promethazine's chemical name is N,N-dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine. Its synthesis involves multi-step chemical processes requiring specialized manufacturing facilities adhering to Good Manufacturing Practices (GMP). APIs for Ethmozine must meet stringent purity, stability, and bioavailability criteria prescribed by regulatory agencies such as the FDA, EMA, and other global bodies.

The API's critical quality attributes include high chemical purity (typically >99%), low residual solvents, and minimal impurities and by-products. Compatibility with pharmaceutical formulations also demands consistent particle size and bioequivalence.

Leading Global API Suppliers for Ethmozine

1. Zhejiang Kangle Pharmaceutical Co., Ltd. (China)

Zhejiang Kangle Pharmaceutical is among China’s prominent API manufacturers specializing in phenothiazine derivatives, including promethazine. The company's manufacturing facilities are GMP-certified, offering high-quality APIs tailored for the global market.

• Strengths:

  • Extensive experience with phenothiazine synthesis.
  • Cost-competitive production scale.
  • Compliance with international quality standards.

• Challenges:

  • Variability in regulatory recognition outside China necessitates comprehensive validation and qualification processes.

• Supply Capabilities:
  Kangle produces bulk quantities with consistent quality, serving both domestic and export markets, including the US, Europe, and emerging markets.

2. Zhejiang Topfond Pharmaceutical Co., Ltd. (China)

Topfond Pharmaceutical has emerged as a key player in phenothiazine APIs, including promethazine, leveraging advanced synthesis technology and robust quality management.

• Strengths:

  • Strong R&D infrastructure enabling process optimization.
  • GMP certification conforming to international standards.
  • Ability to supply customized formulations for specific client needs.

• Quality Assurance:
  Adheres to ISO certifications and implements rigorous quality control measures, with APIs passing comprehensive testing for pharmaceutical grade specifications.

3. M/s. Synthesis Technologies Pvt. Ltd. (India)

This Indian-based API manufacturer has established a reputation for producing high-purity APIs, including promethazine, complying with stringent quality regimes and offering competitive pricing.

• Strengths:

  • Well-versed in complex chemical synthesis.
  • Extensive regulatory approvals.
  • Strong export presence to North America and Europe.

• Validation & Compliance:
  Maintains cGMP-certified facilities aligned with USFDA and EMA guidelines, reducing regulatory hurdles for importing companies.

4. Merck KGaA (Germany)

While Merck primarily focuses on pharmaceutical development and specialty chemicals, it supplies high-quality APIs to select partners through its established division for active ingredients.

• Strengths:

  • Known for pharmaceutical-grade purity and rigorous quality standards.
  • Robust supply chain infrastructure.
  • Extensive R&D capabilities for process improvement.

• Market Position:
  Although not a mass API manufacturer for promethazine, Merck offers bespoke synthesis services or strategic partnerships, especially for high-volume, regulated markets.

5. Faran Farma (Turkey)

Faran Farma has expanded its portfolio to include phenothiazine derivatives, including promethazine, serving Middle Eastern, European, and North African markets.

• Strengths:

  • Cost-effective manufacturing with GMP standards.
  • Competitive lead times.
  • Focused on compliance with European regulatory frameworks.

• Supply Chain Reliability:
  Offers scalable bulk production with documented quality assurance, facilitating seamless integration into client supply chains.

Factors Influencing API Sourcing Decisions

Regulatory Compliance
Manufacturers must comply with cGMP and API-specific standards to ensure regulatory acceptance across markets.

Quality and Purity
API purity levels directly impact drug safety and efficacy. Suppliers with validated analytical methods and documentation are preferred.

Production Capacity
The capacity to meet demand fluctuations and scale production quickly helps mitigate supply disruptions.

Cost and Pricing
While ideally low-cost, API sourcing must balance affordability with quality and regulatory compliance.

Geopolitical and Logistical Considerations
Manufacturing location impacts regulatory pathways, import tariffs, and logistics. Diversified sourcing reduces supply chain risks.

Emerging Trends in API Supply for Ethmozine

• Sustainable Manufacturing Practices: Manufacturers adopting environmentally friendly processes appeal to companies emphasizing green supply chains.

• Regulatory Harmonization: Increasing global regulatory convergence facilitates easier acceptance of APIs from emerging markets.

• Advanced Analytical Techniques: Enhanced quality control using spectrometry, chromatography, and stability testing ensures API consistency.

• Strategic Partnerships: Pharmaceutical firms are increasingly co-developing API manufacturing with suppliers to secure long-term supply agreements.

Ensuring Quality and Supply Security

Pharma companies should conduct comprehensive supplier audits, validate manufacturing processes, and establish qualification protocols for chosen API suppliers. Collaborations with reputable, ISO-certified, and GMP-compliant manufacturers mitigate regulatory risks and safeguard drug quality.

Conclusion

The global supply landscape of Ethmozine (promethazine) APIs is characterized by established manufacturers primarily based in China, India, Turkey, and Europe. On the supply side, China’s phenothiazine API manufacturers dominate due to cost advantages and scaling capacity, while European and Indian manufacturers offer strong compliance credentials and diversified sourcing options.

Ensuring continuity in Ethmozine API supply demands strategic partner selection based on quality, regulatory adherence, capacity, and stability. Emerging trends favor sustainable manufacturing, technological innovation, and diversified supply chains, which collectively support pharmaceutical companies in achieving compliance and operational resilience.

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Key Takeaways

• Diverse Supply Options: Key API suppliers for Ethmozine are located in China, India, Turkey, and Europe, each offering unique advantages in cost, quality, and regulatory compliance.

• Focus on Quality: Maintaining high API purity and adherence to GMP standards is critical for regulatory approval and therapeutic efficacy.

• Supply Chain Resilience: Diversification of suppliers and geographic locations reduces risks associated with geopolitical, logistical, and regulatory disruptions.

• Regulatory Vigilance: Validating supplier compliance with international standards expedites approvals and ensures market access.

• Emerging Opportunities: Sustainable manufacturing and technological advances are shaping the future of Phenothiazine API sourcing.

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FAQs

Q1: Is China the predominant source for Ethmozine APIs?
A1: Yes, Chinese manufacturers dominate the phenothiazine API market, offering cost-effective production capacity. However, pharma companies should verify GMP compliance and regulatory acceptance.

Q2: What quality standards do reputable Ethmozine API suppliers typically meet?
A2: Leading suppliers adhere to cGMP, ISO certifications, and pharmacopeial standards, ensuring API purity, consistency, and safety.

Q3: How can pharmaceutical companies mitigate supply risks associated with Ethmozine API sourcing?
A3: Companies should diversify suppliers across regions, conduct thorough audits, and establish long-term partnerships with validated, compliant manufacturers.

Q4: Are there regulatory challenges when sourcing Ethmozine APIs from emerging markets?
A4: Potential challenges include differing regulatory frameworks; thorough validation, documentation, and supplier audits help mitigate these issues.

Q5: What emerging trends influence Ethmozine API supply chains?
A5: Trends include environmentally sustainable manufacturing, regulatory harmonization, technological advancements in quality control, and strategic supplier collaborations.

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References

1. U.S. Food and Drug Administration (FDA). Active Pharmaceutical Ingredient (API) Verification Program. https://www.fda.gov
2. European Medicines Agency (EMA). Guidelines on Good Manufacturing Practices. https://www.ema.europa.eu
3. "Global API Market Outlook," Pharmaceuticals Technology. (2022).
4. Zhejiang Kangle Pharmaceutical Co., Ltd. Product Catalog.
5. Merck KGaA Official Website. API Manufacturing Capabilities.

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