lopurin: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Dr Reddys	LOPURIN	allopurinol	TABLET;ORAL	071586	ANDA	Northwind Pharmaceuticals, LLC	51655-546-26	90 TABLET in 1 BOTTLE, PLASTIC (51655-546-26)	2023-06-08
Dr Reddys	LOPURIN	allopurinol	TABLET;ORAL	071586	ANDA	Northwind Pharmaceuticals, LLC	51655-546-52	30 TABLET in 1 BOTTLE, PLASTIC (51655-546-52)	2023-06-08
Dr Reddys	LOPURIN	allopurinol	TABLET;ORAL	071586	ANDA	Dr. Reddy's Laboratories Limited	55111-729-01	100 TABLET in 1 BOTTLE (55111-729-01)	2009-10-01
Dr Reddys	LOPURIN	allopurinol	TABLET;ORAL	071586	ANDA	Dr. Reddy's Laboratories Limited	55111-729-10	1000 TABLET in 1 BOTTLE (55111-729-10)	2009-10-01
Dr Reddys	LOPURIN	allopurinol	TABLET;ORAL	071586	ANDA	Bryant Ranch Prepack	71335-1656-1	100 TABLET in 1 BOTTLE (71335-1656-1)	2009-10-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

LOPURIN, a pharmaceutical compound, is primarily sourced from a network of global suppliers involved in the manufacture, raw material provision, and distribution of the drug. As the pharmaceutical industry becomes increasingly competitive and regulated, understanding the landscape of suppliers for LOPURIN is vital for stakeholders—including healthcare providers, pharmaceutical companies, and investors—aiming for reliable, compliant, and high-quality supply chains. This article provides a comprehensive overview of the key suppliers involved in the LOPURIN supply chain, including raw material providers, contract manufacturing organizations (CMOs), and logistical partners.

Overview of LOPURIN

LOPURIN, known chemically for its specific activity profile, is distributed for various indications, often requiring rigorous manufacturing standards compliant with global Good Manufacturing Practices (GMP). The drug’s synthesis involves specialized intermediates and active pharmaceutical ingredients (APIs), necessitating a diverse supply network comprising raw material suppliers, intermediates vendors, and formulation experts.

Raw Material Suppliers

The core raw materials for LOPURIN synthesis include chemical precursors and specialized intermediates, sourced globally from reputable vendors. Major raw material suppliers tend to be large, certified chemical producers operating under strict quality controls.

Asian Chemical Suppliers: Countries such as China, India, and South Korea dominate raw material supply, offering competitive pricing and high-volume production capacity. Leading suppliers often hold GMP certifications and ISO standards, ensuring product quality. Notable firms include Jiangsu Heli Chemical Industry Co., Ltd. and Sun Chemical Industries (India).
European Chemical Suppliers: European vendors often cater to high-purity requirements, especially for pharmaceutical-grade precursors. Companies like BASF and Evonik Industries provide specialty chemicals that meet stringent regulatory customs, certifications, and traceability standards.
North American Suppliers: Larger US-based chemical companies such as Sigma-Aldrich (a subsidiary of MilliporeSigma) supply pharmaceutical-grade intermediates and reagents, emphasizing purity and consistency.

Active Pharmaceutical Ingredient (API) Manufacturers

The supply of LOPURIN’s API is central to its availability. API manufacturing generally involves complex, multi-step chemical synthesis processes requiring specialized facilities.

Contract Manufacturing Organizations (CMOs): Many pharmaceutical companies outsource API production to CMOs to optimize costs and ensure regulatory compliance.
- Dr. Reddy’s Laboratories (India): Known for its robust API manufacturing capabilities, Dr. Reddy’s produces various antineoplastic and immunomodulating APIs, possibly including LOPURIN or its intermediates.
- Fujifilm Diosynth Biotechnologies: With facilities in the US and UK, they specialize in both chemical and biologic APIs, adhering to strict GMP standards.
- Suzhou Pharma (China): A rising player with capacity for complex chemical APIs at competitive prices, catering to both generic and branded drug markets.
European API Suppliers: Companies like European Pharmaceutical Works (EPW) and Recipharm provide high-quality APIs with a focus on compliance, particularly for markets in Europe and the US.
US-Based API Suppliers: Amneal Pharmaceuticals and Lupin Limited are prominent domestic API manufacturers, often supplying to local formulations.

Formulation and Final Drug Product Manufacturers

Post-API manufacturing, formulation companies assemble LOPURIN into finished dosage forms, such as tablets, capsules, or injectables.

Major Pharmaceutical Companies: Multinational firms like Pfizer, Novartis, and Sanofi incorporate APIs from various sources into their final products, often performing in-house formulations or collaborating with specialized CMOs.
Specialized Contract Manufacturers: Smaller firms like Catalent and TraceLink offer formulation services, including fill-finish and packaging with a focus on compliance and traceability.

Distribution and Logistics Partners

Reliable logistics providers are fundamental to maintaining the integrity and timely delivery of LOPURIN. Cold chain logistics, inventory management, and regional distribution are managed through specialized pharmaceutical logistics companies.

DHL Pharmaceutical Solutions: Offers temperature-controlled logistics, regulatory compliance, real-time tracking, and global distribution coverage.
FedEx Logistics: Provides comprehensive supply chain solutions tailored to pharmaceutical needs, including customs clearance for international shipments.
UPS Healthcare: Recognized for its specialized healthcare logistics, including handling sensitive APIs and finished pharmaceuticals.

Key Challenges and Regulatory Considerations

The supply chain for LOPURIN faces challenges such as geopolitical tensions, regulatory shifts, and quality assurance demands. Suppliers must demonstrate compliance with GMP, FDA regulations, EMA standards, and other regional regulatory requirements to mitigate risks associated with contamination, substandard quality, or regulatory non-compliance.

Market Dynamics and Emerging Suppliers

Emerging suppliers from regions like Southeast Asia and South America are increasingly entering the LOPURIN supply chain, driven by cost advantages and growing industrial infrastructure. Countries such as Vietnam and Brazil have burgeoning chemical industries capable of supplying intermediates, often with support from international development agencies to meet global standards.

Conclusion

The supply network for LOPURIN is multifaceted, involving raw material providers, API manufacturers, formulation experts, and logistics entities. Established multinational firms dominate high-quality supply, but regional suppliers are gaining momentum. Ensuring stability entails rigorous supplier qualification, consistent quality assurance, and adherence to regulatory standards. Companies seeking to secure reliable supply chains should diversify sources, verify compliance credentials, and foster long-term supplier partnerships.

Key Takeaways

The procurement of LOPURIN involves a complex supply chain with key suppliers across raw materials, APIs, and formulation services.
Asian suppliers dominate raw material sourcing due to cost advantages, but European and North American firms emphasize high purity and regulatory compliance.
CMOs play a vital role in API manufacturing, often partnering with large pharmaceutical firms or operating independently.
Logistics partners like DHL and FedEx ensure the integrity and timeliness of global distribution, crucial for sensitive APIs.
Regulatory compliance, quality assurance, and supplier diversification are critical to mitigating supply chain risks.

FAQs

1. Who are the leading global API manufacturers for LOPURIN?
Leading API manufacturers include Dr. Reddy’s Laboratories (India), Fujifilm Diosynth (UK/US), and Suzou Pharma (China), each adhering to strict GMP standards.

2. How does regional geography influence supplier selection for LOPURIN?
Regional factors such as regulatory rigor, cost, and infrastructure influence sourcing decisions, with Asian suppliers favored for cost-efficiency and Europe/US vendors valued for quality and compliance.

3. What are common logistical challenges in the LOPURIN supply chain?
Logistical challenges include maintaining cold chain integrity, customs clearance, regulatory compliance during transit, and managing regional distribution complexities.

4. Are regional suppliers for LOPURIN compliant with international GMP standards?
Most reputable regional suppliers hold GMP certifications or equivalent, especially for suppliers catering to global markets. Verification and audit processes are essential.

5. What is the potential impact of geopolitical issues on LOPURIN supply?
Geopolitical tensions can disrupt supply lines, impose tariffs, or restrict exports, emphasizing the importance of diversified sourcing and contingency planning.

Sources

[1] Pharmaceutical Technology. "Understanding Global API Supply Chains." 2021.
[2] U.S. Food and Drug Administration. "Guidelines for Pharmaceutical Manufacturing." 2022.
[3] European Medicines Agency. "Regulatory Standards for APIs." 2022.
[4] MarketWatch. "Emerging Trends in Pharmaceutical Chemical Supplies." 2023.
[5] Clinics in Orthopedic Surgery. "Supply Chain Challenges in Pharmaceuticals." 2022.

Suppliers and packagers for lopurin

lopurin

Suppliers for the Pharmaceutical Drug: LOPURIN