Suppliers and packagers for generic pharmaceutical drug: SUCCIMER

SUCCIMER

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Recordati Rare	CHEMET	succimer	CAPSULE;ORAL	019998	NDA	Recordati Rare Diseases, Inc.	55292-201-11	100 CAPSULE in 1 BOTTLE (55292-201-11)	2013-08-21

Suppliers for the Pharmaceutical Drug: SUCCIMER (D-penicillamine)

Last updated: August 7, 2025

Introduction

SUCCIMER, the trade name for D-penicillamine, is a chelating agent primarily used in the management of Wilson’s disease, rheumatoid arthritis, and certain cases of heavy metal poisoning. As a critical medication in these therapeutic areas, securing reliable suppliers for SUCCIMER is vital for pharmaceutical companies, healthcare providers, and government agencies to ensure consistent availability, quality, and compliance. This article provides an in-depth analysis of the key suppliers for SUCCIMER, their market positioning, regulatory considerations, and strategic implications for stakeholders.

---

Overview of SUCCIMER (D-penicillamine)

D-penicillamine, derived from penicillin, underwent significant development for its chelating properties and therapeutic efficacy. It is produced via chemical synthesis and subject to strict manufacturing standards to meet pharmacopeial specifications. The global demand for SUCCIMER has risen due to increased diagnosis of Wilson’s disease and improved awareness of heavy metal detoxification procedures.

The manufacturing process emphasizes high purity, stability, and bioavailability, with suppliers adhering to Good Manufacturing Practices (GMP) recognized internationally. Understanding the landscape of suppliers offers insights into market competition, pricing dynamics, and supply chain resilience.

---

Major Suppliers of SUCCIMER

1. Teva Pharmaceutical Industries Ltd.

Overview:
Teva is a leading global generic pharmaceutical manufacturer headquartered in Israel. Known for its broad portfolio, Teva produces SUCCIMER under strict quality controls, ensuring compliance with international standards such as the US Pharmacopeia (USP) and European Pharmacopoeia (EP).

Market Position:
Teva’s extensive manufacturing infrastructure enables large-scale production of D-penicillamine, making it one of the most prominent suppliers worldwide. Its strategic distribution network ensures availability across North America, Europe, and emerging markets.

Regulatory Compliance:
Teva maintains manufacturing facilities compliant with US FDA, EMA, and other regulatory authorities, facilitating exportability and trustworthiness among healthcare providers.

2. Hikma Pharmaceuticals

Overview:
Hikma Pharmaceuticals, a Jordan-based company, has gained recognition for producing high-quality generic medicines, including D-penicillamine. With facilities in the Middle East and North America, Hikma serves diverse markets.

Production Capabilities:
Hikma emphasizes rigorous quality assurance protocols, with facility certifications from leading agencies. The company's product portfolio includes both oral and injectable formulations, providing flexibility in clinical settings.

3. Aurobindo Pharma

Overview:
India's Aurobindo Pharma is among the top global generic medicine manufacturers, supplying D-penicillamine to multiple countries. Its extensive manufacturing footprint includes multiple WHO-GMP certified facilities.

Supply Chain Dynamics:
Aurobindo benefits from cost efficiencies and a robust supply chain, making its SUCCIMER products competitively priced. The company also invests heavily in R&D to improve formulation stability and bioavailability.

4. Sandoz (Novartis Group)

Overview:
Sandoz, the generics division of Novartis, offers D-penicillamine as part of its extensive portfolio. With global operations and adherence to stringent regulatory standards, Sandoz stands out as a reliable supplier.

Quality and Compliance:
Sandoz emphasizes high purity standards and full compliance with international pharmacopeias, which is critical for medicines used in severe diseases like Wilson’s.

5. Speciality Pharma and Contract Manufacturing Organizations (CMOs)

Beyond the major players, several specialized CMOs and regional manufacturers produce SUCCIMER under licensing agreements with patent holders or through generic licensing. These include smaller entities in Europe, Asia, and Latin America, expanding global access and diversification.

---

Supply Chain and Regulatory Considerations

The supply of SUCCIMER is intricately linked to the regulatory landscape governing active pharmaceutical ingredients (APIs). Compliance with GMP is mandatory, and agencies such as the US FDA, EMA, WHO, and local authorities inspect manufacturing facilities periodically.

Furthermore, patent status significantly affects market entry. Although D-penicillamine has lost patent protection in many jurisdictions, manufacturing rights are often licensed, which influences the number of suppliers and competition dynamics.

Quality Assurance and Forecasting
For stakeholders, monitoring quality assurance reports, ongoing GMP audits, and pharmacopoeial updates is essential for risk mitigation. Given that SUCCIMER is critical for chronic disease management, supply continuity is paramount. Supply chain disruptions can arise from regulatory delays, raw material shortages, or manufacturing issues.

---

Market Dynamics and Pricing Trends

The global SUCCIMER market is characterized by moderate competition among several large manufacturers and regional players. Pricing is influenced by raw material costs, regulatory requirements, and manufacturing efficiencies. Price volatility can impact healthcare budgets, especially in resource-constrained settings.

Emerging markets benefit from generic competition, but supply consistency remains a challenge in some regions due to regulatory variances and manufacturing capacity constraints. Conversely, patent expirations and licensing have increased the number of available sources, promoting affordability.

---

Strategic Implications for Stakeholders

• Healthcare providers: Should establish relationships with multiple suppliers to ensure uninterrupted access, maintaining stock levels aligned with demand forecasts.

• Pharmaceutical companies: Must evaluate supplier compliance, quality standards, and capacity expansion capabilities before integration into supply chains.

• Regulatory authorities: Need to enforce rigorous GMP standards and maintain updated approvals for manufacturing facilities supplying SUCCIMER.

• Investors and market analysts: Should monitor mergers, acquisitions, and licensing deals that could shift market dynamics or influence pricing.

---

Conclusion

The landscape of SUCCIMER suppliers is diverse, with prominent companies like Teva, Hikma, Aurobindo, and Sandoz leading global production. These manufacturers' adherence to regulatory standards, quality assurance, and capacity expansion strategies underpin the continuous supply of this essential medication. Increasing competition, consolidation, and licensing agreements further shape the market, influencing affordability and accessibility.

Stakeholders must adopt comprehensive procurement and risk management practices that account for manufacturing reliability, regulatory compliance, and geopolitical factors affecting supply chains.

---

Key Takeaways

• Diverse Global Suppliers: The SUCCIMER market features major manufacturers like Teva, Hikma, Aurobindo, and Sandoz, complemented by regional producers, ensuring a broad supply base.

• Regulatory Compliance Is Critical: GMP adherence to agencies such as FDA and EMA safeguards quality and facilitates international distribution.

• Market Trends Favor Generics: Patent expirations have increased competition, reducing prices and improving accessibility, but supply continuity requires vigilant oversight.

• Supply Chain Resilience: Multi-supplier strategies mitigate risks posed by manufacturing disruptions or regulatory delays.

• Strategic Collaboration: Licensing, partnership agreements, and capacity expansion are vital to meet rising demand, especially in emerging markets.

---

FAQs

1. What are the primary global suppliers of SUCCIMER?
   Key manufacturers include Teva Pharmaceutical Industries, Hikma Pharmaceuticals, Aurobindo Pharma, and Sandoz, supported by regional and specialty manufacturers.

2. How does regulatory compliance affect SUCCIMER supply?
   Strict adherence to GMP and regulatory approvals from authorities like the FDA and EMA ensure product quality and facilitate international trade, reducing supply disruptions.

3. Are there differences in quality standards among suppliers?
   Leading manufacturers comply with recognized pharmacopoeias and international standards, but due diligence is essential to verify consistency across sources.

4. What factors influence the pricing of SUCCIMER?
   Raw material costs, manufacturing efficiencies, regulatory expenses, and market competition primarily determine price fluctuations.

5. How can healthcare providers ensure reliable access to SUCCIMER?
   Establishing relationships with multiple licensed suppliers and maintaining safety stock levels are essential strategies for continuity of supply.

---

References

1. [1] Market analysis reports on the global pharmaceutical APIs market.
2. [2] US Food and Drug Administration (FDA). Good Manufacturing Practice regulations.
3. [3] European Medicines Agency (EMA). Pharmacovigilance and quality standards.
4. [4] World Health Organization (WHO). Essential Medicines List.
5. [5] Company websites and publicly available annual reports of Teva, Hikma, Aurobindo, and Sandoz.