Bulk Pharmaceutical API Sources for PROMETH FORTIS

Bulk Pharmaceutical API Sources for PROMETH FORTIS

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		P4651_SIGMA
Molport		MolPort-003-666-272
Hangzhou APIChem Technology		AC-12482

Bulk Active Pharmaceutical Ingredient (API) Sources for: PROMETH FORTIS

Last updated: August 13, 2025

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Introduction

PROMETH FORTIS is a proprietary pharmaceutical formulation combining promethazine, an antihistamine, with other agents aimed at mitigating allergic reactions, nausea, and motion sickness. Its efficacy and safety profile heavily depend on the quality of its Active Pharmaceutical Ingredients (APIs). As demand for PROMETH FORTIS persists globally, sourcing high-quality, reliable bulk APIs becomes pivotal for manufacturers, ensuring regulatory compliance, patient safety, and market competitiveness.

This comprehensive overview explores the primary sources for bulk promethazine API, highlighting key manufacturers, geographic regions, quality standards, and market considerations critical to enterprise decision-makers.

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1. Overview of Promethazine API

Promethazine hydrochloride is a phenothiazine derivative with antihistaminic and sedative properties. Its synthesis involves multi-step chemical processes with strict control measures to ensure impurity profiles align with pharmacopeial standards such as USP, EP, or JP.

The API's quality influences therapeutic efficacy, stability, and safety, making source selection a fundamental component in pharmaceutical supply chains.

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2. Key Global API Manufacturers for Promethazine

2.1. Major Indian API Producers

India remains a leading supplier of promethazine API, driven by robust pharmaceutical manufacturing infrastructure and cost efficiencies.

• Shilpa Medicare Ltd.: Recognized as a WHO-GMP certified manufacturer, Shilpa Medicare exports promethazine API to markets across North America, Europe, and Asia. Their production facilities uphold stringent quality controls aligned with international standards [1].

• Aarti Industries: A reputed Indian pharmaceutical and specialty chemicals manufacturer offering promethazine intermediates and APIs. Their GMP-certified plants equip them for large-scale production catering to global markets [2].

• Hetero Labs: Prominent for its cGMP-compliant APIs, Hetero supplies promethazine hydrochloride globally, with a focus on quality assurance and regulatory compliance [3].

2.2. Chinese API Manufacturers

China has rapidly become a key player in APIs' global supply chain, including promethazine.

• Sichuan Prime Pharmaceutical Co., Ltd.: Offers promethazine hydrochloride complying with USP and GMP standards, catering to both domestic and international clients [4].

• Shandong Luwei Pharmaceutical Co., Ltd.: Engages in the production of phenothiazine derivatives, including promethazine, with certification for international markets [5].

• Others: Several Chinese API producers operate smaller-scale facilities, often exporting to generic drug manufacturers worldwide.

2.3. European and North American Manufacturers

While less prevalent due to higher production costs, some entities in Europe and North America maintain API manufacturing capabilities for niche or specialty needs.

• Bachem AG (Switzerland): Though primarily known for peptide APIs, Bachem maintains a portfolio supporting complex formulations, occasionally providing promethazine intermediates [6].

• Amgen or Teva: Major pharmaceutical firms may have internal manufacturing or approved suppliers for promethazine, primarily for proprietary formulations.

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3. Quality and Regulatory Considerations

Sourcing APIs for PROMETH FORTIS mandates strict adherence to regulatory standards:

• Good Manufacturing Practice (GMP): Ensures consistent quality and safety across batches.

• Pharmacopoeial Compliance: Suppliers must meet USP, EP, or JP specifications for purity, Impurities, residual solvents, and stability.

• Certificate of Analysis (CoA): Essential for verifying compliance with regulatory specifications.

• Regulatory Approvals: Suppliers with recognized regulatory approvals (FDA, EMA, PMDA) facilitate smoother registration and market entry.

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4. Strategic Sourcing Factors

4.1. Supply Chain Reliability

Long-term stability depends on relationships with established manufacturers with proven manufacturing capacity, supply continuity, and contingency plans.

4.2. Cost and Lead Times

India and China offer competitive pricing and large-scale production capabilities but vary in lead times and logistics efficiency. US/EU suppliers might command premium pricing but offer faster response times and higher perceived quality.

4.3. Intellectual Property and Licensing

Ensure API sources operate within legal frameworks concerning patents and intellectual property rights.

4.4. Sustainability and Ethical Practices

Emerging focus on environmentally sustainable processes and ethical sourcing influences procurement choices, especially for high-volume manufacturing.

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5. Future Market Trends and Innovations

• Regulatory Harmonization: Increasing global harmonization may influence API approval pathways and supplier qualification processes.

• Advanced Synthesis Technologies: Implementation of greener, cost-efficient synthetic routes reduces environmental impact and potentially lowers costs.

• Localization of API Production: Increased regional manufacturing aims to mitigate supply chain disruptions, especially post-pandemic.

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6. Conclusion

Reliable sourcing of promethazine API is fundamental for manufacturers of PROMETH FORTIS. Indian and Chinese producers dominate the bulk API market due to cost advantages and expansive manufacturing capacity. However, quality assurance, regulatory compliance, and supply chain robustness demand meticulous provider vetting. Engaging with suppliers holding GMP certifications, recognized pharmacopeial compliance, and proven track records enhances product quality and market confidence.

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Key Takeaways

• Indian and Chinese pharmaceutical manufacturers are primary sources for bulk promethazine hydrochloride, offering competitive pricing and scalable supply.

• Ensuring suppliers’ adherence to GMP, USP/EP/Japanese standards, and possessing robust quality documentation is critical.

• Strategic partnerships should prioritize supply chain stability, regulatory compliance, and sustainable practices.

• Emerging manufacturing technologies and regional production trends aim to improve supply chain resilience and cost-efficiency.

• Companies should diversify supplier bases and establish quality assurance protocols to mitigate risks associated with geopolitical or logistical disruptions.

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FAQs

1. What are the leading countries for sourcing promethazine API?
India and China are the principal global sources, primarily due to their extensive manufacturing infrastructure, cost advantages, and high production scalability.

2. How do I verify the quality of promethazine API from a supplier?
Request comprehensive Certificates of Analysis (CoA), GMP certification, and evidence of compliance with pharmacopeial standards. Conduct supplier audits and perform incoming quality control testing.

3. Are there regional differences in promethazine API quality standards?
Yes, while global standards like USP, EP, and JP are widely recognized, certain regions may have local requirements. Suppliers adhering to internationally recognized standards facilitate smoother regulatory approval.

4. What are the risks associated with sourcing promethazine API from China or India?
Risks include variations in manufacturing quality, supply continuity, geopolitical factors, and regulatory compliance discrepancies. Conduct due diligence and establish quality agreements.

5. Is there an increasing trend toward regional API manufacturing?
Yes, to reduce supply chain vulnerabilities, many companies are investing in regional API production facilities, promoting supply chain resilience and regulatory compliance ease.

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References

[1] Shilpa Medicare Ltd., Official Website. (2023). Manufacturer Credentials and Certification Details.
[2] Aarti Industries Ltd., Corporate Overview. (2023). Global API Production Capabilities.
[3] Hetero Labs Ltd., Product Portfolio and Compliance Certifications. (2023).
[4] Sichuan Prime Pharmaceutical Co., Ltd., GMP Certification and Product Technical Documentation. (2023).
[5] Shandong Luwei Pharmaceutical Co., Ltd., Regulatory Approvals and Export Data. (2023).
[6] Bachem AG, Product Brochure. (2023).

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