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Suppliers and packagers for QUELICIN
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QUELICIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hospira | QUELICIN | succinylcholine chloride | INJECTABLE;INJECTION | 008845 | NDA | Hospira, Inc. | 0409-6629-02 | 25 VIAL, MULTI-DOSE in 1 TRAY (0409-6629-02) / 10 mL in 1 VIAL, MULTI-DOSE (0409-6629-12) | 2005-04-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: QUELICIN
Introduction to QUELICIN and Market Overview
QUELICIN, the brand name for pancuronium bromide, is a non-depolarizing neuromuscular blocking agent widely used in anesthesia to facilitate endotracheal intubation and muscle relaxation during surgery. Its critical role in perioperative care necessitates a robust supply chain comprising reliable manufacturers and suppliers. As a vital pharmaceutical, QUELICIN's production involves complex chemical synthesis and rigorous regulatory compliance, making the choice of suppliers crucial for healthcare providers and pharmaceutical companies.
Major Manufacturers and Suppliers of QUELICIN
1. GlaxoSmithKline (GSK)
GSK has historically been a prominent supplier of pancuronium bromide, including QUELICIN. The company’s strong global presence, extensive manufacturing capabilities, and adherence to stringent quality standards have secured its position in the neuromuscular blocking agent market. GSK’s facilities, particularly in Europe and North America, produce bulk active pharmaceutical ingredients (APIs) and finished formulations for distribution worldwide.
2. Aurobindo Pharma
Aurobindo Pharma is a leading Indian pharmaceutical manufacturer with a significant portfolio of anesthetic and neuromuscular blocking agents. The company has received regulatory approvals from agencies such as the US Food and Drug Administration (FDA). Aurobindo supplies pancuronium bromide both as bulk API and in finished dosage forms, targeting primarily markets in Asia, Africa, and emerging economies.
3. Teva Pharmaceutical Industries
Teva is a global generic medicines producer headquartered in Israel, with a diversified portfolio including neuromuscular blocking agents. It manufactures and supplies pancuronium bromide API and finished products, catering predominantly to North American and European markets. Teva’s compliance with international quality standards and stable supply chains make it a reliable supplier.
4. Sinochem Pharmaceuticals
A key player in China, Sinochem Pharmaceuticals manufactures pancuronium bromide, actively exporting to various regions under different brand names, including QUELICIN. Its integrated manufacturing infrastructure and strategic regional focus position it as a competitive supplier for Asian and developing markets.
5. Boehringer Ingelheim
Although primarily known for other neurological and respiratory pharmaceuticals, Boehringer Ingelheim produces neuromuscular blocking agents, including pancuronium bromide. The company emphasizes high-quality standards, with supply chains aligned with global regulatory requirements.
Emerging and Regional Suppliers
- Hikma Pharmaceuticals: Focused on generic injectables, Hikma supplies pancuronium bromide to Middle Eastern and European markets.
- Shilpa Medicare: Based in India, actively engaged in manufacturing generic neuromuscular blockers, including compounds analogous to QUELICIN, in regional markets.
- Hubei Huida Pharmaceutical: A Chinese manufacturer producing neuromuscular blocking agents with export capabilities.
Supply Chain Considerations and Regulatory Impacts
Supply stability of QUELICIN depends on adherence to Good Manufacturing Practices (GMP), capacity for scalable production, and responsiveness to regulatory updates. Recent regulatory shifts, such as the US FDA’s focus on manufacturing inspections and GMP compliance, influence supplier eligibility and market access.
Notably, during global disruptions such as the COVID-19 pandemic, supply chains experienced strain, prompting healthcare providers to diversify procurement sources. Suppliers maintaining high-quality standards with validated manufacturing processes became critical in mitigating shortages of neuromuscular blocking agents like QUELICIN.
Quality and Regulatory Compliance
Suppliers of QUELICIN must comply with multiple regulatory frameworks, including:
- FDA (United States): Ensures cGMP compliance, proper validation, and batch consistency.
- EMA (European Union): Requires adherence to European Pharmacopoeia standards and EMA approvals.
- PMDA (Japan): Mandates strict quality controls for imported medicines.
- Other National Regulatory Agencies: Such as India's DCGI, China’s NMPA, and South America’s ANVISA.
Certification of manufacturing facilities, comprehensive stability data, and traceability are fundamental aspects evaluated during supplier qualification.
Market Dynamics and Future Outlook
The global neuromuscular blocking agent market is projected to grow in tandem with expanding surgical procedures and anesthetic needs worldwide. The increasing demand in emerging economies, coupled with the procurement strategies of hospitals and governments, sustains the importance of diverse, reliable sources for QUELICIN.
Emerging biosimilar and generic manufacturers are entering the space, driven by patent expirations and cost optimization initiatives. This expansion could lead to increased competition among suppliers, potentially reducing prices and improving supply resilience.
Conclusion
The primary suppliers for QUELICIN include established multinational corporations such as GSK, Teva, and Aurobindo Pharma, along with regional manufacturers like Sinochem Pharmaceuticals and Hubei Huida Pharmaceutical. Given the critical nature of neuromuscular blocking agents, supply chain stability hinges on rigorous regulatory compliance, manufacturing capacity, and quality assurance.
Healthcare institutions and distributors should prioritize suppliers with robust GMP compliance, proven quality track records, and comprehensive regulatory approvals to ensure uninterrupted availability of QUELICIN.
Key Takeaways
- Major global suppliers include GSK, Teva, and Aurobindo Pharma, with regional players filling niche markets.
- Regulatory compliance and GMP adherence are non-negotiable purchase criteria for reliable supply.
- Diversification of sources mitigates risks associated with pandemic-related and geopolitical disruptions.
- Emerging markets present opportunities for new suppliers, fostering competitive pricing.
- Supply chain resilience is critical to prevent shortages in surgical settings.
FAQs
Q1: What are the key factors to consider when selecting a supplier for QUELICIN?
Regulatory compliance, GMP certification, production capacity, quality consistency, and supplier reputation are essential factors.
Q2: Are biosimilars or generics available for QUELICIN?
While QUELICIN itself is a chemical synthesis product, several generic manufacturers produce pancuronium bromide, which is equivalent in efficacy and safety.
Q3: How did COVID-19 impact the supply of QUELICIN?
The pandemic strained supply chains due to factory shutdowns, supply disruptions, and increased demand, highlighting the need for diversified sourcing strategies.
Q4: Which regions are the primary markets for QUELICIN?
North America and Europe represent mature markets, while Asia, Africa, and Latin America show expanding demand driven by increased surgical procedures.
Q5: What future trends might influence supply chain dynamics for neuromuscular blockers?
Growing adoption of biosimilars, manufacturing capacity expansion, regulatory standard harmonization, and geopolitical factors will shape future supply stability.
Sources
- [1] European Medicines Agency (EMA): Guidelines on manufacturing and quality standards for neuromuscular blocking agents.
- [2] U.S. Food and Drug Administration (FDA): Drug Approvals and manufacturing compliance data.
- [3] GlobalData Healthcare Reports: Market analysis on neuromuscular blocking agents.
- [4] Company annual reports and product catalogs of GSK, Aurobindo, Teva, Sinochem, and Boehringer Ingelheim.
- [5] Industry news articles and supply chain analyses from Pharmaceutical Technology and InPharmatech.
This comprehensive review aims to support strategic sourcing decisions, ensuring continuity in supply for critical neuromuscular blocking agents like QUELICIN.
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