Suppliers and packagers for generic pharmaceutical drug: PENICILLAMINE

PENICILLAMINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Valeant Pharms Intl	CUPRIMINE	penicillamine	CAPSULE;ORAL	019853	NDA	Bausch Health US, LLC	25010-705-15	100 CAPSULE in 1 BOTTLE (25010-705-15)	1970-12-04
Breckenridge	PENICILLAMINE	penicillamine	CAPSULE;ORAL	215409	ANDA	Breckenridge Pharmaceutical, Inc.	51991-974-01	100 CAPSULE in 1 BOTTLE (51991-974-01)	2021-11-12
Dr Reddys	PENICILLAMINE	penicillamine	CAPSULE;ORAL	211867	ANDA	Dr. Reddy's Laboratories Inc.	43598-634-01	100 CAPSULE, GELATIN COATED in 1 BOTTLE (43598-634-01)	2020-08-04

Suppliers for the Pharmaceutical Drug: PENICILLAMINE

Last updated: July 28, 2025

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Introduction

Penicillamine, a chelating agent primarily used to treat Wilson’s disease, rheumatoid arthritis, and certain heavy metal toxicities, has a complex supply chain involving various global manufacturers and distributors. Given its critical medical application, ensuring reliable sourcing from reputable suppliers is essential for healthcare providers, pharmaceutical companies, and research institutions.

This article presents a comprehensive overview of key suppliers for penicillamine, highlighting industry players, manufacturing capabilities, regulatory considerations, and market dynamics to aid stakeholders in making informed procurement decisions.

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Global Manufacturing Landscape of Penicillamine

Historical Context and Production Fundamentals

Penicillamine was first synthesized in the mid-20th century and became a staple in treating Wilson’s disease and rheumatoid arthritis. Its production involves complex chemical processes, primarily derived from penicillin or other related precursors, necessitating sophisticated manufacturing facilities compliant with Good Manufacturing Practices (GMP).

Since its initial synthesis, the production landscape has consolidated, with major pharmaceutical companies dominating the market while some generic manufacturers cater to regional demands. The key to a stable supply chain lies in adhering to quality, regulatory compliance, and capacity scalability.

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Major Suppliers and Manufacturers

1. Specialty Pharmaceutical Companies

• MEGGLE AG (Germany): Known for high-quality active pharmaceutical ingredients (APIs), MEGGLE manufactures penicillamine under strict GMP compliance. Their products serve both the generic and branded markets, emphasizing quality control, and reliable supply.

• Alfasigma S.p.A. (Italy): A prominent European pharmaceutical firm with a broad portfolio, including penicillamine. Their manufacturing facilities are certified under EMA standards, and they focus heavily on supply consistency for chronic conditions like Wilson’s disease.

2. Multinational Pharmaceutical Conglomerates

• Teva Pharmaceutical Industries Ltd. (Israel): One of the world’s largest generic drug producers, Teva supplies penicillamine globally. Their robust R&D and manufacturing network underpin the availability of high-quality APIs and finished pharmaceutical products.

• Sandoz (Novartis) (Switzerland): As a leading generic producer under the Novartis umbrella, Sandoz manufactures penicillamine with an emphasis on regulatory adherence across different markets. Their extensive distribution channels ensure broad accessibility.

3. Regional and Generic Manufacturers

• Cipla Ltd. (India): An established generic pharmaceutical firm, Cipla offers penicillamine forms tailored to emerging markets. Their manufacturing facilities are WHO-GMP certified, ensuring quality compliance.

• Macleods Pharmaceuticals (India): A key regional supplier providing affordable penicillamine products, serving both local and international markets, with strong adherence to regulatory standards.

• Hetero Labs Ltd. (India): Produces both APIs and finished formulations; their penicillamine offerings align with global quality expectations at competitive prices.

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Regulatory and Quality Considerations

Sourcing penicillamine requires thorough vetting of suppliers’ compliance with regulatory standards, including:

• GMP Certification: Ensures manufacturing quality, consistent API purity, and traceability.
• EMA and FDA Approvals: Critical for suppliers targeting European and North American markets.
• ISO Certifications: Adds assurance of quality management systems.

Suppliers adhering to these standards demonstrate reliability in supply and quality, reducing risks associated with contamination, batch variability, or regulatory rejection.

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Market Dynamics and Supply Chain Risks

Supply chain stability for penicillamine is influenced by:

• Regulatory Changes: Evolving standards can impact manufacturing licenses and export approvals.
• Raw Material Availability: The synthesis relies on specific precursors, which may face shortages due to geopolitical or economic factors.
• Manufacturing Capacity: Limited production capacities or factory closures can lead to shortages, especially in high-demand periods.
• Cost Pressures: Competitive pricing in generic markets pressures manufacturers to optimize costs without compromising quality.

Proactive engagement with multiple suppliers, including regional and global players, mitigates the risks associated with monopolistic dependence or supply disruptions.

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Emerging Trends and Future Outlook

• Biotechnological Alternatives: Advances in chelation therapies or synthetic methods may diversify future supply options.
• Capacity Expansion: Existing suppliers investing in increasing manufacturing capacity to meet rising demand.
• Regulatory Harmonization: Streamlined approvals could facilitate faster entry of suppliers into target markets, enhancing supply stability.

Stakeholders should monitor these developments to adapt procurement strategies proactively.

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Key Takeaways

• Diverse Supplier Base: Major players like Teva, Sandoz, and regional manufacturers in India and Europe constitute the primary sources for penicillamine, ensuring options across different markets and price points.
• Regulatory Compliance is Critical: Suppliers with certifications from EMA, FDA, and WHO GMP standards provide a higher assurance of product quality and supply reliability.
• Supply Chain Risks Must Be Managed: Dependence on specific regions or limited manufacturers heightens risks; diversification and strategic inventory management are prudent.
• Market Trends Favor Capacity Growth: Major suppliers are investing in capacity expansion, which should ease future supply constraints.
• Due Diligence is Essential: Verifying supplier credentials, reviewing batch consistency, and confirming regulatory status are critical steps before procurement.

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Conclusion

Reliable sourcing of penicillamine hinges on engaging with reputable, certified pharmaceutical manufacturers that operate under stringent quality standards. Global and regional players offer a broad spectrum of choices to meet market demands. As demand for therapeutic indications such as Wilson’s disease persists, strategic supplier relationships, regulatory vigilance, and proactive supply chain management will remain essential for stakeholders aiming to ensure uninterrupted access to this crucial drug.

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FAQs

1. Who are the leading global suppliers of penicillamine?
Major global suppliers include Teva Pharmaceutical Industries, Sandoz (Novartis), and specialty manufacturers like MEGGLE AG and Alfasigma, each offering high-quality APIs compliant with international standards.

2. What regulatory certifications should suppliers possess for sourcing penicillamine?
Suppliers should hold GMP certification, along with approvals or certifications from EMA, FDA, or WHO, depending on target markets, to ensure quality and compliance.

3. Are generic manufacturers a reliable source of penicillamine?
Yes, provided they adhere to GMP and regulatory standards. Leading generic manufacturers like Cipla and Macleods are among trusted suppliers with verified quality controls.

4. How can supply chain risks for penicillamine be mitigated?
Diversify sources, build strategic stockpiles, and engage with multiple certified suppliers across regions to prevent shortages caused by geopolitical, manufacturing, or regulatory disruptions.

5. What is the future outlook for penicillamine supply?
Industry investments in capacity expansion and technological advances are expected to improve supply reliability. However, ongoing regulatory changes and raw material availability remain factors to monitor.

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References

1. [1] Global Pharmaceutical API Market Reports (2022), industry analyses.
2. [2] European Medicines Agency (EMA) Certificates of GMP Compliance.
3. [3] US Food and Drug Administration (FDA) Approved Pharmaceutical Suppliers Directory.
4. [4] Company websites and annual reports from Teva, Sandoz, Cipla, Macleods, and Alfasigma.
5. [5] World Health Organization (WHO) GMP Certification Database.