Bulk Pharmaceutical API Sources for PHENERGAN VC

Bulk Pharmaceutical API Sources for PHENERGAN VC

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-7C03311
RR Scientific		R6440204

Bulk Active Pharmaceutical Ingredient (API) Sources for PHENERGAN VC

Last updated: December 9, 2025

Summary

Phenergan VC, a combination medication containing promethazine and phenylephrine, is widely used to treat allergy symptoms, cold, and flu. The drug’s efficacy depends on the consistency and purity of its active pharmaceutical ingredients (APIs). This comprehensive overview examines the global API sources for promethazine and phenylephrine—highlighting key manufacturers, sourcing strategies, regulatory considerations, and supply chain risks—necessary for pharmaceutical companies, formulators, and supply chain managers to optimize procurement and ensure regulatory compliance.

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What Are the Key APIs in PHENERGAN VC?

API	Function	Purity Standards	Typical Dosage Forms
Promethazine	Antiemetic, antihistamine	≥ 98% purity, WHO grade, USP/NF	Syrup, tablets, injections
Phenylephrine	Decongestant, vasoconstrictor	≥ 99% purity, USP/NF	Syrup, tablets, drops

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Which Global API Manufacturers Supply Promethazine?

Promethazine APIs are produced primarily in regions with established pharmaceutical manufacturing expertise, notably:

Manufacturer	Country	Certifications	Production Capacity	Notes
Sanofi Aventis	France, China	cGMP, ISO 9001, WHO-GMP	High	Original patent holder; significant market share
Hikma Pharmaceuticals	UK, Jordan	cGMP, ISO 9001	Moderate	Focuses on generic APIs
Zhejiang Huahai	China	cGMP, ISO 9001	Large	Major supplier for generics
Jiangsu Hengrui	China	cGMP, ISO 9001, WHO-GMP	Large	Emerging supplier for global markets

Notes:

• Promethazine API is often sourced from Chinese and Indian suppliers owing to cost advantages.
• Approval status varies; some APIs are labeled as “generic” with corresponding active development data.

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Which Global API Manufacturers Supply Phenylephrine?

Phenylephrine APIs are produced mainly by:

Manufacturer	Country	Certifications	Production Capacity	Notes
Hangzhou Meibao	China	cGMP, ISO 9001	Large	Leading Chinese producer; supplies global markets
Kanion Pharmaceutical	China	cGMP, ISO 9001, WHO-GMP	Large	Focus on reliable decongestant API production
Sino Chemical	China	cGMP, ISO 9001	Moderate	Supplies to both branded and generic formulations
GSK (GlaxoSmithKline)	UK	cGMP	Limited	Some high-purity APIs used for proprietary formulations

Notes:

• Phenylephrine API manufacturing is heavily concentrated in China, with increasing entries from India.

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Sourcing Strategies for APIs: How Do Manufacturers Secure Supply?

Strategy	Benefits	Challenges
Establishing Long-term Supplier Contracts	Cost stability, reliable supply chain	Dependence on specific suppliers, geopolitical risks
Diversifying Supplier Base	Mitigates supply disruptions	Quality management complexity
In-house API Production	Guarantees supply, quality control	High capital investment, longer approval timelines
Partnership with Contract Manufacturing Organizations (CMOs)	Flexibility, scaling options	Regulatory compliance, oversight requirements

Key Insight: Most companies adopt a mixed strategy, balancing in-house production, long-term supplier agreements, and outsourcing to CMOs to ensure uninterrupted supply of promethazine and phenylephrine.

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Regulatory Landscape Impacting API Sourcing

Regulatory Authority	Relevant Policies	Impact on API Sourcing
FDA (U.S.)	cGMP requirements; Drug Master Files (DMFs)	Ensures API quality; influences supply chain decisions
EMA (Europe)	EudraLex guidelines, Qualified Person (QP) certification	Demands rigorous compliance, affecting API import/export processes
WHO	Good Manufacturing Practices (GMP) for APIs	Standardizes quality requirements globally
Chinese SFDA / CFDA	Manufacturing quality standards	Rapid API production growth, with increasing focus on quality oversight

Insight: Regulatory strictness directly influences supplier selection, quality assurance processes, and import strategies, especially within the U.S. and European markets.

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Key Supply Chain Risks and Mitigation Strategies

Risk Type	Description	Mitigation Approaches
Supplier Concentration	Heavy reliance on Chinese and Indian APIs	Diversify geographic sourcing, validate multiple suppliers
Regulatory Non-compliance	Quality discrepancies, regulatory violations	Implement rigorous audits, enforce comprehensive quality standards
Geopolitical Instability	Trade restrictions, tariffs, export bans	Monitor geopolitical developments, adjust sourcing accordingly
Supply Disruptions	Pandemics, natural disasters	Maintain safety stock, establish backup supply sources

Strategic Recommendation: Regularly assess supply chain resilience, involve early engagement with multiple high-quality API suppliers, and incorporate flexible procurement contracts.

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Comparison of Major API Suppliers: Promethazine vs. Phenylephrine

Criteria	Promethazine API	Phenylephrine API
Producer Countries	France, China, India	China, India
Typical Certification Status	cGMP, WHO-GMP (for major suppliers)	cGMP, WHO-GMP
Production Capacity	High capacity, especially in China	Large capacity, predominantly Chinese firms
Cost Considerations	Moderate to low, depending on region	Competitive pricing, mainly Chinese origin
Quality Standards	High, with GMP compliance	High, with GMP compliance
Regulatory Approval Complexity	Requires DMF submission, audit readiness	Similar, often under strict regulatory oversight

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Future Trends in API Sourcing for PHENERGAN VC

• Increased Chinese API manufacturing capacity driven by government subsidies and infrastructure investments.
• Global push for API quality standardization through the International Conference on Harmonisation (ICH) guidelines.
• Rise of API manufacturing in India with a focus on cost competitiveness and expanding capacity.
• Enhanced regulatory scrutiny leads to more rigorous supplier qualification and API validation processes.
• Supply chain digitization and blockchain-based traceability to ensure authenticity and prevent counterfeits.

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Comparison with Other Antihistamine and Decongestant APIs

API	Common Uses	Alternative APIs	Cost Range (USD/kg)	Regulatory Notes
Promethazine	Allergy, antiemetic	Diphenhydramine, chlorpheniramine	$20 - $35	Stringent quality control required
Phenylephrine	Nasal decongestant	Pseudoephedrine, oxymetazoline	$15 - $30	Restrictions apply due to pseudoephedrine regulation

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Key Considerations for Buyers of API for PHENERGAN VC

1. Quality Assurance: Verify certifications (cGMP, ISO, WHO-GMP).
2. Supply Chain Stability: Develop relationships with multiple suppliers.
3. Regulatory Compliance: Ensure API DMF and Certificates of Suitability.
4. Pricing Trends: Monitor raw material costs and currency fluctuations.
5. Lead Times: Establish clear procurement timelines aligned with manufacturing schedules.

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Key Takeaways

• Dominant suppliers for promethazine and phenylephrine APIs are primarily located in China and India, emphasizing the importance of diligent source verification.
• Regulatory landscapes with strict GMP and DMF requirements influence supplier qualification and supply chain robustness.
• Supply chain risks are mitigated through multi-sourcing, strategic alliances, and quality audits.
• Pricing and capacity trends indicate growing production capabilities in China, with India emerging as a cost-effective alternative.
• Future trajectories point to increased regulatory standardization, technological integration, and diversification to ensure API supply continuity.

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FAQs

Q1: What are the primary countries manufacturing promethazine and phenylephrine APIs?
A: China and India dominate API production for both promethazine and phenylephrine, supported by extensive manufacturing infrastructure and cost advantages. European and US manufacturers, like Sanofi and GSK, produce high-purity APIs primarily for their own formulations.

Q2: How do regulatory policies impact API sourcing for PHENERGAN VC?
A: Regulatory authorities enforce GMP standards, which require comprehensive documentation, facility audits, and certifications. Non-compliance can lead to supply delays or bans, emphasizing the importance of partnering with certified suppliers.

Q3: What risks are associated with heavy reliance on Chinese API suppliers?
A: Risks include geopolitical tensions, trade restrictions, quality variability, and supply disruptions. Diversification and rigorous supplier qualification mitigate these risks.

Q4: Are there alternatives to Chinese API sources for promethazine and phenylephrine?
A: Yes. Indian suppliers are a growing alternative, with increasing capacity and quality standards. European and US manufacturers offer high-end APIs but at higher costs and with limited capacity.

Q5: What are the future outlooks for API procurement in this space?
A: Expect expanded manufacturing capacity in China and India, increased regulatory oversight, and technological advancements like blockchain for traceability—driving a more resilient and compliant supply chain landscape.

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References

1. U.S. Food and Drug Administration (FDA): https://www.fda.gov
2. European Medicines Agency (EMA): https://www.ema.europa.eu
3. World Health Organization (WHO): https://www.who.int
4. Pharmaceuticals Business Intelligence Reports, 2022
5. GlobalAPI Market Analysis, IQVIA, 2022

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This detailed review provides a strategic foundation for pharmaceutical stakeholders aiming to optimize API sourcing for PHENERGAN VC, balancing cost, quality, and regulatory compliance.