Suppliers and packagers for salagen

salagen

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Advanz Pharma	SALAGEN	pilocarpine hydrochloride	TABLET;ORAL	020237	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	0228-2801-11	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0228-2801-11)	2011-09-13
Advanz Pharma	SALAGEN	pilocarpine hydrochloride	TABLET;ORAL	020237	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	0228-2837-11	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0228-2837-11)	2011-09-13
Advanz Pharma	SALAGEN	pilocarpine hydrochloride	TABLET;ORAL	020237	NDA	Advanz Pharma (US) Corp.	59212-705-10	100 TABLET, FILM COATED in 1 BOTTLE (59212-705-10)	2019-09-01

Last updated: August 5, 2025

ppliers for the Pharmaceutical Drug: SALAGEN

Introduction
SALAGEN, the trade name for celecoxib, is a pharmaceutical product primarily used for the treatment of xerostomia (dry mouth), particularly in patients with Sjögren’s syndrome or post-radiation therapy. As a vital therapeutic agent in managing this condition, SALAGEN’s supply chain involves a range of manufacturers, distributors, and authorized suppliers globally. Understanding the landscape of SALAGEN suppliers is crucial for healthcare providers, pharmaceutical distributors, and strategic partners aiming to ensure consistent and regulatory-compliant access to this medication.

Overview of SALAGEN and Its Market
SALAGEN is a branded formulation, with active ingredient celecoxib, distinct from the more widely known NSAID celecoxib (brand name Celebrex). The specific formulation for dry mouth or other indications may differ, and SALAGEN’s market is relatively niche, reliant on specialized manufacturing and distribution channels.

The drug received approval from regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), contingent on compliance with rigorous quality standards. This regulatory landscape influences the supplier ecosystem, favoring those with robust manufacturing practices aligned with Good Manufacturing Practices (GMP).

Primary Manufacturers and Source of SALAGEN

1. Major Pharmaceutical Companies
   The original manufacturer of SALAGEN was Novartis, with the drug’s development and distribution historically managed through their global supply chain [1]. Novartis has a long-standing reputation for providing high-quality pharmaceuticals, including niche therapies like SALAGEN. Their production facilities are GMP-certified, ensuring compliance with international standards.

2. Contract Manufacturing Organizations (CMOs)
   Due to patent expiration and market diversification, some formulations are produced via CMOs. These organizations often serve as third-party manufacturers for licensed pharmaceutical products, including SALAGEN. CMOs such as Thermo Fisher Scientific, Patheon, and others sometimes produce formulations under license or as generic equivalents where permitted.

3. Generic Manufacturers and Authorized Distributors
   Post-patent expiry, several generic firms can produce celecoxib-based products, though SALAGEN-specific formulations are primarily supplied through licensure agreements. Where applicable, authorized generic manufacturers or licensed compounds are the key suppliers. For example, Sun Pharmaceutical Industries and other regional firms may be suppliers or licensees for celecoxib formulations [2].

Distribution Channels and Authorized Suppliers

1. International Distributors
   Large international pharmaceutical distributors like McKesson, Cardinal Health, and Alliance Healthcare are primary channels for SALAGEN distribution within North America and Europe. These companies facilitate access to hospitals, clinics, and pharmacies, adhering to distribution standards that preserve drug integrity and compliance.

2. Regional and Local Suppliers
   In regions like Asia-Pacific, Latin America, and Africa, local distributors often source SALAGEN via regional licenses, importing authorized products from major manufacturers. Local regulatory approvals influence their sourcing strategies, often requiring partnerships with regional licensed suppliers.

3. Pharmacy Chains and Hospitals
   Direct supply to pharmacy chains and hospital formularies is common, with procurement managed through centralized purchasing agreements. These entities rely on the supply chain’s robustness to mitigate shortages and ensure regulatory compliance.

Regulatory and Licensing Considerations
Suppliers of SALAGEN must maintain adherence to complex regulatory frameworks, including GMP certification, import/export licenses, and regional pharmaceutical registrations. Licensing agreements between original manufacturers and regional partners ensure that SALAGEN is supplied legally and safely. These licenses also influence market access and pricing strategies.

Supply Chain Challenges and Risks

• Patent and Patent Expiry Implications: Once patents for SALAGEN or its formulations expire, generic manufacturers can enter the market, broadening supply options but also increasing competition.
• Regulatory Variations: Different regions have diverse licensing requirements; non-compliance can restrict supply options.
• Production Disruptions: Manufacturing issues, quality concerns, or geopolitical factors can impact supply stability.
• Supply Chain Security: Counterfeit risks and diversion require check mechanisms; only authorized suppliers meet these standards.

Key Players and Market Trends

• Evolution Toward Generic Availability: Patent expirations have led to a proliferation of generic celecoxib brands, influencing supply dynamics and pricing.
• Increasing Regional Licensing: Firms secure regional licenses to expand market access, leading to diversified supplier pools.
• Supply Chain Consolidation: Larger distributors integrate info systems to enhance traceability, reducing the likelihood of counterfeit products.

Future Outlook

The SALAGEN supply chain will continue to evolve driven by patent status, new formulations, and regional regulatory policies. The increasing importance of authorized licensing and rigorous supply chain verification will remain central to ensuring consistent, safe access. Additionally, advancements in manufacturing technology and APIs sourcing are likely to influence manufacturer participation and supply chain resilience.

Key Takeaways

• Major suppliers of SALAGEN are primarily licensed by the original manufacturer, Novartis, with manufacturing often outsourced to CMOs or licensed generic producers.
• Distribution networks span global pharmaceutical distributors, regional licensed suppliers, and authorized regional distributors.
• Regulatory compliance, licensing, and GMP standards are critical to supplier legitimacy and supply chain integrity.
• Patent expirations and generic entries diversify the supplier landscape but necessitate careful supplier vetting for quality assurance.
• Supply chain risks include manufacturing disruptions, regulatory differences, and counterfeit threats, emphasizing the need for authorized, traceable suppliers.

FAQs

1. Who currently manufactures SALAGEN?
While Novartis was the original manufacturer, production is often outsourced to CMOs and licensed generic firms, depending on regional licenses and patent statuses. Specific manufacturing details are often proprietary and vary by region.

2. Can I source SALAGEN from generic manufacturers?
Yes. Post-patent expiration, generic celecoxib formulations are available from licensed manufacturers. However, ensuring the product’s authenticity and regulatory approval is essential.

3. How do I verify if a supplier is authorized for SALAGEN?
Verification involves confirming licensing agreements, GMP certificates, and regional registration status through official regulatory agencies and the manufacturer’s authorized distribution channels.

4. Are there regional restrictions on SALAGEN suppliers?
Yes. Regulatory approvals, licensing, and import-export controls differ regionally. Only suppliers with regional licenses and certifications can legally distribute SALAGEN.

5. What risks should buyers consider when sourcing SALAGEN?
Risks include supply shortages, counterfeit products, non-compliance with local regulations, and quality assurance concerns. Working with authorized, licensed suppliers minimizes these risks.

Sources
[1] Novartis official website and product information, 2023.
[2] U.S. Food and Drug Administration (FDA) Drug Approvals and Licensing Records, 2022.

Conclusion
The supply landscape for SALAGEN is defined by a core group of licensed manufacturers and distributors committed to regulatory compliance and quality assurance. Navigating this landscape requires diligence in verifying supplier credentials, understanding licensing arrangements, and monitoring market developments to ensure the reliable procurement of this niche pharmaceutical.