Suppliers and packagers for oxazepam

oxazepam

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Tp Anda Holdings	OXAZEPAM	oxazepam	CAPSULE;ORAL	071026	ANDA	TruPharma, LLC	52817-290-10	100 CAPSULE in 1 BOTTLE (52817-290-10)	2021-06-01
Tp Anda Holdings	OXAZEPAM	oxazepam	CAPSULE;ORAL	071026	ANDA	TruPharma, LLC	52817-291-10	100 CAPSULE in 1 BOTTLE (52817-291-10)	2021-06-01
Tp Anda Holdings	OXAZEPAM	oxazepam	CAPSULE;ORAL	071026	ANDA	TruPharma, LLC	52817-292-10	100 CAPSULE in 1 BOTTLE (52817-292-10)	2021-06-01
Tp Anda Holdings	OXAZEPAM	oxazepam	CAPSULE;ORAL	071026	ANDA	Aphena Pharma Solutions - Tennessee, LLC	71610-639-30	30 CAPSULE in 1 BOTTLE (71610-639-30)	2021-06-01
Tp Anda Holdings	OXAZEPAM	oxazepam	CAPSULE;ORAL	071026	ANDA	Aphena Pharma Solutions - Tennessee, LLC	71610-639-53	60 CAPSULE in 1 BOTTLE (71610-639-53)	2021-06-01

Suppliers for the Pharmaceutical Drug: Oxazepam

Last updated: July 28, 2025

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Introduction

Oxazepam, a benzodiazepine derivative, is widely utilized for anxiety management, alcohol withdrawal, and sleep disorders. As an established anxiolytic and sedative, its global demand persists, compelling pharmaceutical manufacturers and healthcare providers to identify reliable suppliers. This comprehensive review catalogs primary suppliers, evaluates their market positioning, regulatory compliance, and strategic competencies, enabling stakeholders to make informed procurement decisions.

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Overview of Oxazepam and Market Dynamics

Oxazepam originated in the 1960s and gained approval globally, especially in Europe and North America. Its favorable safety profile, including reduced risks of dependence relative to other benzodiazepines, sustains its market presence. The compound's production involves complex synthesis routes—primarily via chemical synthesis of substituted benzodiazepines—requiring strict quality control to meet pharmaceutical standards.

Market demand is driven by both generic formulations and branded products. Despite competition from newer anxiolytics, oxazepam maintains relevance owing to its safety and cost-effectiveness. Consequently, a spectrum of suppliers, ranging from multinational pharmaceutical manufacturers to chemical ingredient specialists, participate across the supply chain.

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Leading Pharmaceutical Suppliers of Oxazepam

1. Stada Arzneimittel AG (Germany)
   Market Position & Capabilities: A European generics leader, Stada manufactures pharmaceutical-grade oxazepam, adhering to Good Manufacturing Practice (GMP). Their extensive distribution network ensures broad market availability.
   Regulatory Compliance: Certified under EMA standards; actively maintains compliance with international standards such as ISO 9001.

2. Mundipharma International Ltd (UK)
   Market Focus: Known for producing high-quality generics, including benzodiazepines, with a focus on stringent quality standards.
   Supply Reliability: Long-standing reputation for consistent supply and regulatory compliance across markets, including Europe and Asia.

3. Amneal Pharmaceuticals (USA)
   Product Portfolio: Offers generic benzodiazepines, including oxazepam, with a focus on North American markets.
   Quality Assurance: FDA-licensed manufacturing facilities with extensive quality control systems.

4. Kopran Limited (India)
   Manufacturing Capabilities: Supplies active pharmaceutical ingredients (APIs) and finished formulations for global markets.
   Cost Competitiveness: Offers cost-effective sourcing options owing to lower manufacturing costs, subject to regulatory approvals in importing countries.

5. Jiangsu Nhwa Pharmaceutical Co., Ltd (China)
   Market Reach: Engages in biosimilar and API production, including benzodiazepine APIs like oxazepam.
   Regulatory Landscape: Complies with Chinese GMP; efforts ongoing to attain approvals for export in regulated markets.

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API Suppliers Specializing in Oxazepam

Beyond finished product manufacturers, several API suppliers provide the essential active pharmaceutical ingredients:

• Hubei Yanquing Pharmaceutical (China)
• Jiangsu Hengrui Medicine Co., Ltd (China)
• LKT Laboratories (USA)
• Cipla Limited (India)
• BASF SE (Germany)

These API producers often cater to multiple finished drug manufacturers, providing bulk API needed for formulation.

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Regulatory and Quality Considerations

Suppliers must demonstrate compliance with multiple regulatory standards:

• Good Manufacturing Practice (GMP): Ensures products meet safety, purity, and efficacy requirements.
• Pharmacopoeial Standards: API and finished formulations should adhere to USP, EP, or BP monographs, depending on market destination.
• Certificates of Analysis (CoA): Essential documentation confirming batch quality.
• Regulatory Approvals: Export licenses, GMP certifications, and following import regulations in target markets are crucial.

Purchasers should verify supplier certifications through official agencies like the EMA, FDA, or respective national authorities.

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Emerging Suppliers and Market Trends

New entrants, especially from India and China, are expanding their market share via cost-effective production and strategic alliances. Advanced chemical synthesis techniques and process optimizations enable these suppliers to meet global quality standards.

Additionally, the trend toward biosimilars and alternative anxiolytics has an impact on oxazepam demand. Nonetheless, manufacturers continue to rely on a diversified supplier base to mitigate risks related to supply disruptions, regulatory changes, and price fluctuations.

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Strategic Procurement Considerations

• Supplier Qualification: Evaluate suppliers based on compliance history, capacity, and supply chain robustness.
• Cost vs. Quality: Balance cost savings against quality assurance; prioritize suppliers with validated quality management systems.
• Regulatory Compatibility: Confirm suppliers’ ability to meet regional regulatory requirements and provide necessary documentation.
• Supply Chain Resilience: Diversify supplier base to guard against geopolitical, logistical, or compliance-related disruptions.

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Key Challenges in Supplier Selection

• Regulatory Divergence: Variability in GMP standards and approval processes across jurisdictions complicates supplier validation.
• Supply Chain Transparency: Ensuring traceability from raw material sourcing through manufacturing is critical to maintain integrity.
• Price Volatility: API production and procurement costs fluctuate with raw material prices, exchange rates, and regulatory burdens.

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Conclusion

The landscape of oxazepam suppliers encompasses established pharmaceutical companies, API producers, and emerging players, primarily across Europe, North America, India, and China. Success hinges on comprehensive compliance with regulatory standards, consistent quality, and reliable supply logistics. Stakeholders should conduct rigorous supplier audits, ensure transparent documentation, and maintain diversified sourcing strategies to sustain ongoing supply efficacy.

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Key Takeaways

• Multiple suppliers across regions ensure supply security; prioritize those with verified GMP compliance and regulatory certifications.
• API quality directly influences finished product safety; verify suppliers’ adherence to pharmacopoeial standards.
• Cost-effective sourcing from emerging markets necessitates thorough validation of quality assurance processes.
• Diversification of suppliers mitigates risks related to regulatory changes, geopolitical factors, and supply chain disruptions.
• Regular review and audit of suppliers maintain compliance and uphold product integrity in the supply chain.

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Frequently Asked Questions

1. What factors should be considered when selecting a supplier for oxazepam?
Regulatory compliance, GMP certification, production capacity, quality control protocols, cost, delivery reliability, and geographical considerations.

2. Are Chinese and Indian suppliers compliant with international standards?
Many are. Chinese and Indian API producers often meet GMP, ISO, and pharmacopoeial standards, but due diligence and qualification processes are essential before procurement.

3. How does regulatory approval affect supplier choice?
Suppliers must comply with regional regulatory frameworks (EMA, FDA, etc.). Verifying their certifications, documentation, and past regulatory compliance ensures market access and reduces risk.

4. What are the supply chain risks associated with oxazepam sourcing?
Regulatory divergences, raw material shortages, geopolitical tensions, logistical disruptions, and quality issues.

5. Is it beneficial to source oxazepam from multiple suppliers?
Yes. Diversifying mitigates risks, enhances supply resilience, and can optimize costs; however, it requires robust supplier qualification and quality assurance protocols.

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References

[1] European Medicines Agency. “Guidelines on Good Manufacturing Practice.” EMA, 2022.
[2] U.S. Food and Drug Administration. “Active Pharmaceutical Ingredient Compliance Program.” FDA, 2023.
[3] MarketWatch. “Global Benzodiazepine Market Report,” 2022.
[4] Pharmaceutical Technology. “API Manufacturers and Supply Chain Dynamics,” 2021.
[5] WHO. “Prequalification of Medicines Program,” 2023.