Suppliers and packagers for BALSALAZIDE DISODIUM

BALSALAZIDE DISODIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apotex	BALSALAZIDE DISODIUM	balsalazide disodium	CAPSULE;ORAL	077883	ANDA	AvPAK	50268-102-13	30 BLISTER PACK in 1 BOX (50268-102-13) / 1 CAPSULE in 1 BLISTER PACK (50268-102-11)	2014-11-06
Apotex	BALSALAZIDE DISODIUM	balsalazide disodium	CAPSULE;ORAL	077883	ANDA	Apotex Corp.	60505-2575-0	10 BLISTER PACK in 1 CARTON (60505-2575-0) / 10 CAPSULE in 1 BLISTER PACK	2007-12-28
Apotex	BALSALAZIDE DISODIUM	balsalazide disodium	CAPSULE;ORAL	077883	ANDA	Apotex Corp.	60505-2575-3	30 CAPSULE in 1 BOTTLE (60505-2575-3)	2007-12-28

Suppliers for the Pharmaceutical Drug: BALSALAZIDE DISODIUM

Last updated: July 29, 2025

Introduction

Balsalazide Disodium is an oral prodrug used primarily in the management of ulcerative colitis, a form of inflammatory bowel disease. Belonging to the class of azitholines, it is converted in the colon to mesalamine, which exerts anti-inflammatory effects. As a specialty pharmaceutical, Balsalazide Disodium’s supply chain involves various active pharmaceutical ingredient (API) manufacturers, formulation specialists, and distribution channels. Securing reliable suppliers is critical for pharmaceutical companies, healthcare providers, and wholesalers to ensure consistent drug availability. This comprehensive overview examines the key suppliers and manufacturing landscape for Balsalazide Disodium.

Global API Manufacturers for Balsalazide Disodium

The backbone of Balsalazide Disodium’s supply chain is the production of its API. The APIs must meet stringent quality, purity, and regulatory standards dictated by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Several pharmaceutical companies and contract manufacturing organizations (CMOs) globally are known for producing azitholines and similar API compounds.

1. Alphapharm (AbbVie)

AbbVie, through its subsidiary Alphapharm, has historically been a significant producer of Balsalazide Disodium. As part of its specialization in gastrointestinal therapeutics, Alphapharm supplies APIs directly to pharmaceutical firms and generic drug manufacturers, ensuring high-quality standards tailored for ulcerative colitis treatments. Their rigorous quality controls and regulatory compliance make them a key player in the API supply chain.

2. Sandoz (Novartis)

Sandoz, a division of Novartis, produces generic APIs, including Balsalazide Disodium, serving the global market. Its extensive manufacturing network and adherence to Good Manufacturing Practices (GMP) position Sandoz as a major supplier for generic formulations, including Balsalazide Disodium. Their competitive pricing and reliable supply chain make them a preferred partner for generic drug production.

3. First Source Pharma

This Indian-based contract manufacturer specializes in small-molecule APIs for gastrointestinal drugs. First Source Pharma has developed capabilities for synthesizing Balsalazide Disodium with regulatory-compliant quality, serving both domestic and international markets. Their manufacturing facilities are cGMP-compliant, and they have established strategic partnerships in North America and Europe.

4. Nanjing Nanjing Pharmaceutical Factory (China)

Nanjing Nanjing Pharmaceutical Factory is among Chinese API producers with growing capabilities in specialty pharmaceuticals for inflammatory bowel disease (IBD). Their manufacturing standards align with GMP, and the company exports APIs globally, including Balsalazide Disodium, often at competitive prices due to manufacturing cost advantages.

5. Amoli Organics (India)

Amoli Organics is a recognized API manufacturer with an expanding portfolio in anti-inflammatory and gastrointestinal medication APIs. Their production of Balsalazide Disodium emphasizes raw material quality and supply consistency, offering an alternative for pharmaceutical firms seeking diversified sourcing options in Asia.

Contract Manufacturing and Exclusive Suppliers

In addition to primary API producers, several pharmaceutical companies rely on contract manufacturing organizations (CMOs) that specialize in formulation and packaging. These CMOs often procure APIs from multiple suppliers, including those listed above, to ensure continuous production.

• Therapeutic dose form contract manufacturers like Pharmascience or Teva Pharmaceutical Industries are engaged globally for formulation and final product manufacturing coupled with supply chain management.

• Exclusive sourcing agreements are common, particularly in large pharmaceutical firms seeking stable supply and quality assurance, creating long-term relationships with specific API producers.

Regional Supply Dynamics and Market Trends

North America & Europe: These regions tend to source APIs from established manufacturers with stringent regulatory compliance, primarily AbbVie subsidiaries and European CMOs. Due to regulatory demands, North American and European firms prioritize suppliers with extensive GMP certifications.

Asia-Pacific: India and China are pivotal regions for API manufacturing, driven by cost competitiveness and expanding manufacturing capacity. Companies like Amoli Organics and Nanjing Nanjing Pharmaceutical Factory supply entire markets or are engaged via licensing agreements to produce Balsalazide Disodium for local and export use.

Emerging Markets: Countries including Mexico, Brazil, and Southeast Asian nations have increasingly become viable sources, leveraging local manufacturing infrastructure to reduce costs and supply chain disruptions.

Regulatory & Quality Considerations

API suppliers must strictly comply with international standards, including:

• Good Manufacturing Practices (GMP): GMP certification is mandatory for production of APIs intended for human pharmaceutical use.

• Regulatory approvals: Suppliers should hold approvals or accreditation from authorities such as the FDA, EMA, or TGA.

• Batch consistency & purity: Suppliers are expected to demonstrate rigorous quality control, with specifications aligning with pharmacopoeia standards (USP, EP, or JP).

• Supply continuity: Suppliers with diversified manufacturing sites and inventory management capabilities reduce risks of shortages, an essential aspect for critical drug products like Balsalazide Disodium.

Distribution Channels & Wholesale Suppliers

Once manufactured, Balsalazide Disodium reaches pharmaceutical formulators, generics manufacturers, and wholesalers through established distribution networks. Key players include:

• McKesson Corporation and Cardinal Health — Major pharma distributors in North America offering logistic support for finished formulations.
• Alliance Healthcare (Europe) — Provides distribution across European markets, ensuring compliance with regional regulations.
• Local distributors — In emerging markets, regional distributors and authorized agents facilitate API importation and drug registration.

Conclusion

Securing a reliable supply of Balsalazide Disodium requires strategic engagement with multiple high-quality API manufacturers. The leading producers are predominantly based in North America, Europe, and Asia, with established GMP compliance and regulatory accreditations. For pharmaceutical companies and formulators, diversification of supplier base, rigorous quality controls, and understanding regional dynamics are critical for uninterrupted supply and regulatory compliance.

Key Takeaways

• Supplier selection: Prioritize GMP-certified manufacturers with proven quality and regulatory approval records, such as AbbVie, Sandoz, and Indian CMOs.
• Geographic diversification: Leverage a mix of North American, European, and Asian suppliers to mitigate supply risks.
• Regulatory compliance: Ensure suppliers meet international standards to avoid regulatory delays or quality issues.
• Long-term partnerships: Develop strategic relationships with primary API producers for stability and better negotiating power.
• Market trends: Monitor regional supply dynamics, especially the expanding Chinese and Indian manufacturing sectors, which offer cost-effective sourcing options.

FAQs

1. Who are the primary global suppliers of Balsalazide Disodium API?

Leading suppliers include AbbVie's Alphapharm, Sandoz (Novartis), First Source Pharma (India), Nanjing Nanjing Pharmaceutical Factory (China), and Amoli Organics (India), all compliant with GMP standards.

2. What factors should a pharmaceutical company consider when choosing an API supplier for Balsalazide Disodium?

Key considerations include regulatory compliance, GMP certification, supply capacity, quality consistency, cost competitiveness, and supplier reliability.

3. Are there regional differences in Balsalazide Disodium API manufacturing?

Yes. North America and Europe focus on high-quality, regulated sources like Alphapharm and Sandoz, while India and China offer cost-effective production options with growing GMP capabilities.

4. How has the supply chain for Balsalazide Disodium evolved recently?

The supply chain has diversified, with increased manufacturing capacity in Asia and stricter regulatory oversight in established markets, emphasizing quality assurance and supply continuity.

5. What role do CMOs play in the Balsalazide Disodium supply chain?

CMOs handle formulation, packaging, and distribution, often sourcing APIs from multiple producers to ensure operational flexibility and risk mitigation.

Sources:

[1] Global Pharmaceutical API Market Analysis, 2022.
[2] FDA GMP Regulations.
[3] European Medicines Agency Guidelines.
[4] Company websites and industry reports for Alphapharm, Sandoz, and Chinese API manufacturers.