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Suppliers and packagers for generic pharmaceutical drug: PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
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PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Genus | PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE | phenylephrine hydrochloride; promethazine hydrochloride | SYRUP;ORAL | 040654 | ANDA | Genus Lifesciences Inc. | 64950-345-16 | 473 mL in 1 BOTTLE, PLASTIC (64950-345-16) | 2024-07-15 |
| Amneal Pharms | PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride; promethazine hydrochloride | SYRUP;ORAL | 040902 | ANDA | Amneal Pharmaceuticals LLC | 65162-679-86 | 118 mL in 1 BOTTLE (65162-679-86) | 2009-08-25 |
| Amneal Pharms | PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride; promethazine hydrochloride | SYRUP;ORAL | 040902 | ANDA | Amneal Pharmaceuticals LLC | 65162-679-90 | 473 mL in 1 BOTTLE (65162-679-90) | 2009-08-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drugs: Phenylephrine Hydrochloride and Promethazine Hydrochloride
Introduction
Phenylephrine hydrochloride and promethazine hydrochloride are widely utilized pharmaceuticals in clinical settings. Phenylephrine primarily functions as a vasoconstrictor for short-term nasal decongestion and as an agent to maintain blood pressure during anesthesia, while promethazine serves as an antihistamine for allergy relief, antiemetic, and sedative purposes. The global supply chain for these compounds is complex, involving numerous manufacturers specializing in active pharmaceutical ingredients (APIs), intermediates, and finished formulations. Analyzing the landscape of suppliers helps stakeholders optimize sourcing strategies, ensure compliance, and mitigate risks associated with supply disruptions.
Market Overview of Pharmaceutical Suppliers
The supply of phenylephrine hydrochloride and promethazine hydrochloride is distributed across leading API manufacturers predominantly in China, India, and Europe. These regions host a concentration of production facilities with robust regulatory standards and capacity for bulk manufacturing. The competitive dynamics are influenced by factors such as regulatory approvals, manufacturing quality, pricing, and supply chain reliability. This section examines key players supplying these pharmaceuticals, considering their production capacity, geographic distribution, and market share.
Suppliers of Phenylephrine Hydrochloride
1. Chinese Manufacturers
China maintains a dominant position in the global production of phenylephrine hydrochloride, with numerous API suppliers capable of catering to global demand. Several Chinese companies, such as Zhejiang Pharmaceutical Co., Ltd., and Changzhou Yabang Pharmaceutical Co., Ltd., are recognized for their large-scale production capacities, adherence to Good Manufacturing Practices (GMP), and competitive pricing structures. These companies often supply both bulk API and finished dosage forms, and are certified by regulatory authorities like the CFDA (China Food and Drug Administration).
2. Indian Producers
India's pharmaceutical sector boasts several API manufacturers, including Sun Pharmaceutical Industries Ltd., Aarti Drugs Ltd., and Granules India Ltd., which produce phenylephrine hydrochloride to meet domestic and export demands. Indian companies benefit from lower manufacturing costs and a well-developed API infrastructure compliant with WHO and USFDA standards, making them reliable suppliers for global markets.
3. European and North American Suppliers
European companies like Sanofi and Novartis, while primarily focused on finished formulations, also maintain API manufacturing sites for phenylephrine hydrochloride. North American players tend to source API components from trusted Chinese and Indian suppliers due to cost considerations, although some large pharmaceutical companies maintain their own manufacturing plants for quality control.
Suppliers of Promethazine Hydrochloride
1. Global API Manufacturers
Promethazine hydrochloride has a more limited number of dedicated API manufacturers owing to its chemical complexity and regulatory scrutiny. Notable suppliers include Hubei KNC Pharmaceutical Co., Ltd. (China), which offers high-quality API for export markets. Other Chinese companies like Zhejiang Sunflower Pharmaceutical Co., Ltd. serve as key suppliers, leveraging established manufacturing standards.
2. Indian Suppliers
Indian pharmaceutical companies such as Alembic Pharmaceuticals and Gufic Biosciences have incorporated promethazine hydrochloride into their API portfolios, supplying both domestic and international markets. Their manufacturing capabilities are compliant with international standards, and they often provide customized formulations to meet specific regulatory requirements.
3. Regional and Contract Manufacturing
Some pharmaceutical companies opt for contract manufacturing organizations (CMOs) in India and China to produce promethazine hydrochloride, primarily to mitigate capacity limitations and reduce costs. These CMOs are certified by regulatory agencies like USFDA, EMA, and WHO, providing assurance for global supply.
Emerging Trends and Considerations
Supply Chain Diversification
Over-reliance on Chinese and Indian suppliers has intensified concerns over supply disruptions due to geopolitical tensions, trade restrictions, and pandemic-related manufacturing challenges. Diversifying supplier bases and engaging multiple sources across regions are proactive strategies.
Regulatory Compliance
Suppliers must demonstrate compliance with GMP, Current Good Manufacturing Practices (cGMP), and international drug regulatory standards. Certifying documents, such as USFDA 483s or EMA approvals, are critical indicators of supplier reliability.
Quality and Pricing Dynamics
While low-cost suppliers dominate the market, quality assurance remains paramount. Suppliers with consistent quality, regulatory approvals, and transparent quality management systems effectively balance cost and risk.
Impact of COVID-19
The pandemic disrupted global supply chains, leading to shortages and delays. Many suppliers scaled up capacity, adopted intensified quality controls, and invested in contingency planning, influencing supplier selection decisions.
Key Players Summary
| Supplier Region | Notable Companies | Focus Area | Regulatory Certifications | Market Share Indicators |
|---|---|---|---|---|
| China | Zhejiang Pharmaceutical, Hubei KNC | API production | CFDA, WHO-GMP | Major source of phenylephrine and promethazine APIs |
| India | Sun Pharma, Aarti Drugs, Alembic | API & Formulations | USFDA, WHO-GMP | Significant role in global supply, cost-effective |
| Europe/North America | Sanofi, Novartis | Finished formulations | EMA, USFDA | Limited API manufacturing; primarily finished products |
Regulatory and Quality Assurance
Compliance with international standards such as USFDA, EMA, and WHO-GMP is critical in supplier selection. Suppliers with active inspections, validated processes, and transparent quality documentation mitigate regulatory and safety risks. Monitoring updates from agencies like USFDA Warning Letters or industry audits supports ongoing sourcing decisions.
Conclusion
The supply landscape for phenylephrine hydrochloride and promethazine hydrochloride is characterized by a core group of Chinese and Indian API manufacturers, supplemented by regional producers in Europe and North America. While cost benefits make Chinese and Indian suppliers predominant, increasing emphasis on regulatory adherence and supply security encourages diversification and rigorous supplier qualification processes. Business stakeholders must balance cost, quality, and supply chain resilience to secure a stable source of these essential pharmaceuticals.
Key Takeaways
- Global sourcing involves a diversity of suppliers predominantly based in China and India. Companies should vet suppliers based on regulatory compliance, quality systems, and capacity.
- Supply chain risks can be mitigated through diversification and supplier qualification. Relying solely on a few sources exposes businesses to geopolitical and pandemic-related disruptions.
- Regulatory compliance is non-negotiable; suppliers should possess GMP certifications and recent inspection approvals from recognized authorities.
- Emerging trends favor transparent, compliant, and scalable suppliers, especially as supply chain resilience becomes a strategic priority.
- Monitoring market developments, regulatory updates, and supplier performance is essential for maintaining a reliable supply of phenylephrine and promethazine APIs.
FAQs
1. Are there any new suppliers emerging for phenylephrine hydrochloride and promethazine hydrochloride?
Emerging suppliers are primarily based in Southeast Asia and Eastern Europe, with small to mid-sized API manufacturers expanding capacity and seeking regulatory approvals to meet growing demand.
2. How does regulatory compliance impact supplier qualification?
Regulatory compliance ensures that APIs meet safety, efficacy, and quality standards mandated by authorities like USFDA, EMA, or WHO. Non-compliant suppliers pose risks of supply rejection, regulatory action, and compromised product quality.
3. What are the primary considerations when selecting an API supplier for these drugs?
Key considerations include regulatory approval status, manufacturing capacity, quality assurance practices, pricing, lead times, and the supplier’s track record of compliance and reliability.
4. How has the COVID-19 pandemic influenced the API supply chain for these drugs?
The pandemic caused disruptions through factory shutdowns, logistical delays, and increased demand. These factors prompted diversification efforts, increased inventory buffering, and more stringent supplier vetting.
5. Can contract manufacturing organizations (CMOs) reliably supply phenylephrine and promethazine APIs?
Yes, provided they are certified by relevant regulatory agencies and have demonstrated consistent compliance and quality. CMOs are becoming a strategic option to expand capacity and mitigate risks.
Sources
[1] U.S. Food and Drug Administration (USFDA) Database
[2] European Medicines Agency (EMA) Reports
[3] Global API Market Reports (2022)
[4] Industry supplier directories and regulatory filings
[5] Company disclosures and press releases
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