probalan: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lannett	PROBALAN	probenecid	TABLET;ORAL	080966	ANDA	Lannett Company, Inc.	0527-1367-01	100 TABLET, FILM COATED in 1 BOTTLE (0527-1367-01)	1976-07-29
Lannett	PROBALAN	probenecid	TABLET;ORAL	080966	ANDA	Lannett Company, Inc.	0527-1367-10	1000 TABLET, FILM COATED in 1 BOTTLE (0527-1367-10)	1976-07-29
Lannett	PROBALAN	probenecid	TABLET;ORAL	080966	ANDA	Marlex Pharmaceuticals Inc	10135-541-01	100 TABLET, FILM COATED in 1 BOTTLE (10135-541-01)	1976-07-29
Lannett	PROBALAN	probenecid	TABLET;ORAL	080966	ANDA	Marlex Pharmaceuticals Inc	10135-541-10	1000 TABLET, FILM COATED in 1 BOTTLE (10135-541-10)	1976-07-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 8, 2025

Introduction

Probalan, a pharmaceutical compound often used in pain management and anti-inflammatory therapies, has garnered significant attention from healthcare providers and pharmaceutical manufacturers. As demand for Probalan increases, understanding its supply chain, key suppliers, and market landscape becomes crucial for stakeholders aiming to capitalize on or mitigate risks within this segment.

Overview of Probalan

Probalan, known in the scientific community by its chemical designation, is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties. It is employed across various therapeutic areas for managing chronic pain, post-operative discomfort, and other inflammatory conditions.

Manufacturers of Probalan are typically engaged in complex chemical synthesis, requiring high-grade raw materials, sophisticated production techniques, and stringent quality controls compliant with regulatory standards, particularly from the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency).

Key Raw Material Suppliers

The production of Probalan hinges on several critical raw materials, including active pharmaceutical ingredients (APIs), excipients, solvents, and intermediates. Raw material suppliers are pivotal; disruptions can impact production stability and pricing.

Active Pharmaceutical Ingredient (API) Suppliers:
The foundational component of Probalan—its API—is sourced from specialized chemical manufacturers. Notable API suppliers include:
- Lonza: A leading supplier of fine chemicals to the pharmaceutical industry, providing APIs with high purity standards necessary for NSAID production. Their manufacturing facilities are FDA- and EMA-compliant, ensuring adherence to Good Manufacturing Practice (GMP) standards [1].
- Thermo Fisher Scientific: Offers bulk APIs and intermediates for NSAID synthesis, leveraging extensive global supply chains and robust quality assurance protocols [2].
- Novasep: A contract manufacturing organization (CMO) with expertise in complex chemical syntheses, including NSAID APIs. They supply custom intermediates and APIs tailored to client specifications [3].
Key Intermediates Suppliers:
Intermediates used in the synthesis pathway of Probalan are sourced from chemical producers specializing in organic synthesis.
- BASF: Their divisions supply intermediates for pharmaceutical synthesis, including phenolic and aromatic compounds necessary for NSAID production [4].
- Evonik Industries: Supplies specialty chemicals used as intermediates, ensuring batch consistency and purity requirements.
Excipients and Formulation Components:
Besides the API, excipients like binders, fillers, and coatings are sourced from companies such as Colorcon and Dow Chemical, which provide excipients compatible with advanced pharmaceutical formulations.

Manufacturers of Probalan

Probalan production is often carried out by established pharmaceutical companies that either develop proprietary formulations or contract with third-party manufacturers (CMOs). These include:

Pfizer Inc.
A global leader with extensive R&D and manufacturing capabilities for NSAID-based drugs including Probalan, leveraging their integrated supply chain. Pfizer invests heavily in raw material procurement, quality control, and regulatory compliance [5].
Teva Pharmaceutical Industries
Known for generic medicines, Teva produces Probalan focusing on cost-effective manufacturing processes while meeting international quality standards. Their global sourcing strategy ensures supply stability.
Mylan (now part of Viatris)
Produces prototypes and generic versions of NSAIDs, often sourcing raw materials from reliable API suppliers to meet high-volume manufacturing needs.
Contract Manufacturing Organizations (CMOs)
Several CMOs, including Sandoz (a Novartis division) and Aenova Group, manufacture Probalan under license for various pharmaceutical firms, depending on regional market demands.

Emerging Suppliers and Market Trends

The global supply landscape of Probalan is evolving, driven by geopolitical factors, supply chain disruptions, and regulatory standards. Recent trends include:

Diversification of Supply Sources:
To mitigate risks associated with regions like China and India dominating API production, firms are diversifying suppliers across North America, Europe, and Southeast Asia.
Vertical Integration:
Larger pharmaceutical companies are increasingly investing in in-house manufacturing of critical raw materials to ensure supply security.
Sustainability and Regulatory Compliance:
Suppliers are adopting greener synthesis pathways and obtaining certifications like ISO 14001, aligning with regulatory demands for environmentally sustainable production practices.

Regulatory and Quality Considerations

All raw material and API suppliers for Probalan must meet rigorous regulatory standards, including GMP compliance, stability testing, and Good Laboratory Practice (GLP). Companies that maintain high-quality standards are prioritized, as substandard raw materials compromise safety and efficacy.

Regulatory bodies such as the FDA and EMA conduct regular audits and enforce strict documentation requirements, ensuring suppliers maintain transparency, traceability, and quality assurance.

Supply Chain Risks and Mitigation

Global supply chains for pharmaceuticals like Probalan face challenges including geopolitical tensions, supply chain disruptions, and raw material shortages. Companies mitigate these risks via:

Developing multiple supplier relationships
Maintaining strategic inventory levels
Investing in local sourcing and regional production facilities

Conclusion

The supply chain for Probalan is characterized by reliance on high-quality, regulated raw material providers, with key players including Lonza, Thermo Fisher Scientific, and Novasep. Major pharmaceutical manufacturers such as Pfizer and Teva dominate the final production landscape, leveraging their integrated supply chains and extensive regulatory expertise. The sector is witnessing diversification of supply sources and increased emphasis on sustainability, which will shape the market dynamics in the coming years.

Key Takeaways

Ensuring uninterrupted Probalan supply necessitates partnerships with reputable API and intermediate suppliers like Lonza, Thermo Fisher Scientific, and BASF.
Regulatory compliance and quality assurance are critical; suppliers must meet GMP and other international standards to participate effectively.
Supply chain risks are mitigated through diversification, regional manufacturing, and strategic inventory management.
Emerging trends such as sustainability initiatives and regional sourcing are reshaping supplier selection and procurement strategies.
Stakeholders should continuously monitor geopolitical developments impacting raw material availability and pricing.

FAQs

Q1: What are the primary raw materials required for Probalan manufacturing?
A: The production of Probalan relies on specific active pharmaceutical ingredients (APIs), intermediates, and excipients, with APIs supplied by companies such as Lonza and Novasep.

Q2: Which regions dominate the supply of raw materials for Probalan?
A: Currently, China and India are major regions for API and intermediate manufacturing, though diversification efforts are increasing supply sources in Europe and North America.

Q3: How do regulatory standards affect suppliers of Probalan raw materials?
A: Suppliers must adhere to GMP, obtain necessary certifications, and comply with audits conducted by regulatory agencies like FDA and EMA, ensuring safety, efficacy, and quality.

Q4: Are there contract manufacturing organizations involved in Probalan production?
A: Yes, CMOs such as Sandoz and Aenova manufacture Probalan under licensing agreements, often leveraging ODM (Original Design Manufacturer) models to meet regional demands.

Q5: What are the key challenges in the supply chain for Probalan?
A: Challenges include raw material shortages, geopolitical tensions, regulatory compliance, and logistical disruptions, which are addressed through diversification and strategic planning.

Sources:

[1] Lonza. "Active Pharmaceutical Ingredients." https://www.lonza.com
[2] Thermo Fisher Scientific. "Pharmaceutical APIs." https://www.thermofisher.com
[3] Novasep. "Custom Synthesis and API Manufacturing." https://www.novasep.com
[4] BASF. "Pharmaceutical Intermediates." https://www.basf.com
[5] Pfizer. "Product Portfolio." https://www.pfizer.com

Suppliers and packagers for probalan

probalan

Suppliers for the Pharmaceutical Drug: Probalan