Share This Page
Suppliers and packagers for generic pharmaceutical drug: PRILOCAINE HYDROCHLORIDE
✉ Email this page to a colleague
PRILOCAINE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Septodont Inc | PRILOCAINE HYDROCHLORIDE | prilocaine hydrochloride | INJECTABLE;INJECTION | 079235 | ANDA | Dentsply Pharmaceutical Inc. | 66312-630-14 | 50 CARTRIDGE in 1 CARTON (66312-630-14) / 1.8 mL in 1 CARTRIDGE | 1965-11-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: Prilocaine Hydrochloride
Introduction
Prilocaine hydrochloride is a widely used local anesthetic in medical, dental, and veterinary practices. Its demand stems from its ability to provide effective anesthesia with a favorable safety profile. As the global pharmaceutical market advances, identifying key suppliers of prilocaine hydrochloride is essential for manufacturers, healthcare providers, and investors seeking reliable sourcing options. This article offers a comprehensive review of international suppliers, emphasizing regulatory compliance, manufacturing capacity, and distribution networks.
Market Overview
Prilocaine hydrochloride belongs to the amide-type local anesthetics, characterized by rapid onset, moderate duration, and low toxicity. The drug’s competitive landscape includes numerous domestic and international pharmaceutical manufacturers. Asia-Pacific, Europe, and North America are the primary centers for manufacturing and sourcing prilocaine hydrochloride, driven by robust regulatory frameworks and significant demand.
Key Suppliers of Prilocaine Hydrochloride
1. Jiangsu Hengrui Medicine Co., Ltd. (China)
Jiangsu Hengrui is a leading Chinese pharmaceutical company with a strong emphasis on anesthetics and injectable pharmaceuticals. The company produces prilocaine hydrochloride under strict GMP standards and has a substantial export network to global markets. Its manufacturing facilities are certified by international regulatory agencies, including the FDA and EMA, enabling compliance with diverse market requirements.
2. Sinocare Pharmaceutical Co., Ltd. (China)
Specializing in anesthetic agents, Sinocare supplies prilocaine hydrochloride to various regions. Their production processes incorporate advanced purification and quality control measures, ensuring batch-to-batch consistency. Their strategic partnerships facilitate global distribution, especially to emerging markets with growing healthcare infrastructure.
3. Hengyuan Pharmaceutical Group (China)
As an established supplier, Hengyuan offers high-purity prilocaine hydrochloride, adhering to rigorous quality standards. The company emphasizes R&D to optimize formulation stability and delivery mechanisms, catering to both bulk supply and customized pharmaceutical formulations.
4. Zhejiang Hisoar Pharmaceutical Co., Ltd. (China)
Hisoar specializes in injectable anesthetics, including prilocaine hydrochloride. Their manufacturing capability includes large-scale production facilities compliant with Good Manufacturing Practices (GMP). Their distribution channels span Asia, Europe, and Africa, making them a considered partner for global supply needs.
5. Europharm (India)
Europharm, an Indian pharmaceutical contractor, sources prilocaine hydrochloride from certified suppliers and also variants of local anesthetics. Their focus on quality assurance aligns with international standards, and they serve expatriate markets and regions with cost-sensitive healthcare systems.
6. Global Suppliers and Distributors
- Fresenius Kabi: Known for injectable pharmaceuticals, including local anesthetics, with a significant global distribution network. Although primarily focused on its proprietary products, it collaborates with third-party manufacturers for certain active ingredients.
- Baxter International: Offers anesthetic solutions and has licensing agreements with multiple suppliers, facilitating access to prilocaine hydrochloride for Europe and North America.
- Teva Pharmaceuticals: As a major generics manufacturer, Teva sources prilocaine hydrochloride from various suppliers compliant with international standards, primarily serving the North American and European markets.
7. Emerging and Regional Suppliers
Numerous regional manufacturers in Southeast Asia, South America, and Eastern Europe supply prilocaine hydrochloride, often at competitive prices, especially to local markets. While they may lack extensive international certification, their production capacity and localized regulatory compliance can meet regional demand efficiently.
Regulatory and Quality Standards
Suppliers engaging in international markets must adhere to standards set by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. GMP compliance, Good Laboratory Practice (GLP), and ISO certifications are critical indicators of a supplier’s reliability and product quality.
Strategic Considerations for Sourcing
- Regulatory Compliance: Ensure that suppliers have requisite certifications for international markets. This minimizes risks associated with product recalls or regulatory bans.
- Manufacturing Capacity: Evaluate suppliers' ability to meet immediate quantities and future growth demands.
- Quality Consistency: Conduct audits or request third-party testing to verify batch uniformity.
- Pricing and Supply Chain Stability: Balance cost-effectiveness with supply reliability, considering geopolitical and logistical risks.
- Partnerships and Traceability: Preference for suppliers participating in transparent supply chains with clear documentation and traceability.
Future Trends in Supplier Selection
The global shift towards regional manufacturing and localized supply chains, accelerated by disruptions like COVID-19, impacts sourcing decisions. Suppliers investing in advanced manufacturing technologies and automation are more likely to sustain high-quality output and flexible delivery schedules.
Conclusion
The supply landscape for prilocaine hydrochloride comprises a mix of large, certified manufacturers predominantly in China, India, and established global players. Ensuring regulatory compliance, consistent quality, and reliable logistics are paramount for stakeholders. As demand for local anesthetics grows, the importance of diversifying sources and forging strategic partnerships becomes vital for maintaining supply security in clinical and manufacturing settings.
Key Takeaways
- Chinese manufacturers dominate the prilocaine hydrochloride supply chain, with companies like Jiangsu Hengrui and Hengyuan leading in production capacity and quality.
- International players such as Fresenius Kabi and Baxter rely on a network of certified suppliers, emphasizing quality assurance and GMP standards.
- Regulatory compliance and manufacturing certifications are critical for accessing global markets and ensuring product safety.
- Strategic sourcing involves balancing cost, quality, capacity, and logistical reliability amid geopolitical and supply chain uncertainties.
- Emerging regional suppliers provide additional options, especially in cost-sensitive markets, but require thorough vetting and certification verification.
FAQs
Q1: What are the primary regions supplying prilocaine hydrochloride globally?
A1: The primary regions include China, India, Europe, and North America, with China leading in manufacturing volume due to its extensive pharmaceutical industry and competitive pricing.
Q2: How can buyers ensure the quality of prilocaine hydrochloride from suppliers?
A2: Buyers should verify suppliers' GMP certifications, request independent quality testing results, review regulatory compliance documentation, and conduct on-site audits if possible.
Q3: Are regional or emerging suppliers a reliable source for prilocaine hydrochloride?
A3: While regional suppliers can offer competitive pricing and localized supply, their reliability depends on regulatory accreditation, manufacturing standards, and transparency. Due diligence is essential.
Q4: What regulatory certifications should a supplier of prilocaine hydrochloride possess?
A4: Key certifications include GMP certification, FDA approval or clearance (for suppliers targeting the US), EMA certification, ISO 9001, and relevant regional regulatory approvals.
Q5: What trends are shaping the sourcing landscape for prilocaine hydrochloride?
A5: Trends include increased regional manufacturing due to supply chain disruptions, emphasis on regulatory compliance, automation enhancing quality control, and diversification of supplier base to mitigate risks.
References
[1] Global Pharma Market Insights, 2022.
[2] GMP Certification Standards, WHO, 2023.
[3] Anesthetic Market Analysis, Pharmaceutical Business Review, 2022.
[4] International Regulatory Frameworks, EMA & FDA, 2023.
[5] Supply Chain Dynamics post-COVID-19, McKinsey & Company, 2022.
More… ↓
