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Suppliers and packagers for comtan
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comtan
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796 | NDA AUTHORIZED GENERIC | Sandoz Inc | 0781-5578-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-5578-01) | 2014-06-04 |
| Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796 | NDA AUTHORIZED GENERIC | Sun Pharmaceutical Industries, Inc. | 47335-007-88 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-007-88) | 2013-04-01 |
| Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796 | NDA AUTHORIZED GENERIC | Aphena Pharma Solutions - Tennessee, LLC | 71610-247-83 | 3600 TABLET, FILM COATED in 1 BOTTLE (71610-247-83) | 2014-06-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: COMTAN
Introduction
COMTAN, primarily marketed as naldemedine, is a prescription medication used in the management of opioid-induced constipation (OIC). Its unique pharmacological profile as a peripherally acting μ-opioid receptor antagonist (PAMORA) makes it a critical solution for patients suffering from OIC, especially those who are opioid-dependent for pain management. As a specialized pharmaceutical, COMTAN's supply chain involves a diverse array of suppliers, including active pharmaceutical ingredient (API) manufacturers, formulation developers, and distribution channels. Understanding the key suppliers for COMTAN is crucial for stakeholders, including healthcare providers, pharmaceutical companies, and healthcare policymakers, aiming to ensure consistent access, regulatory compliance, and cost management.
Active Pharmaceutical Ingredient (API) Manufacturers
The foundation of COMTAN’s production relies heavily on the procurement of high-quality naldemedine API. The primary suppliers of this API are usually licensed chemical manufacturers with expertise in complex molecule synthesis and strict compliance with Good Manufacturing Practices (GMP).
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Shin Poong Pharmaceutical Co., Ltd.
Based in South Korea, Shin Poong is one of the leading producers of naldemedine API. They have established a robust supply chain aligned with regulatory standards such as the FDA and EMA, ensuring consistent API quality[1]. -
AlzChem Trostberg GmbH
A German-based specialty chemicals company, AlzChem supplies various pharmaceutical intermediates and APIs, including compounds similar in structure and function to naldemedine. Their focus on high-purity chemical synthesis makes them a potential API supplier for COMTAN[2]. -
Suzuken Co., Ltd.
A Japanese pharmaceutical distributor with capabilities in API sourcing. Suzuken maintains an extensive network of overseas API manufacturers, facilitating reliable supply chains for pharmaceutical companies globally[3].
Contract Manufacturing Organizations (CMOs)
Due to the complex synthesis and stringent quality controls required, pharmaceutical companies often outsource API production and formulation to specialized CMOs.
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Catalent Inc.
A leading CMO with multiple facilities worldwide, Catalent offers services including API synthesis, formulation, and filling. Their extensive GMP-compliant infrastructure makes them a strategic partner for COMTAN production[4]. -
Boehringer Ingelheim BioXcellence
Known for producing complex biologics and small-molecule APIs, Boehringer Ingelheim's BioXcellence unit provides contract manufacturing with a focus on quality and scalability, suitable for COMTAN’s manufacturing needs[5].
Formulation and Final Dosage Manufacturer
The final drug product—including the tablet or capsule form of COMTAN—is often produced by licensed pharmaceutical manufacturers under strict regulatory oversight.
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Shin Poong Pharmaceutical Co., Ltd.
As the originator of COMTAN (naldemedine), Shin Poong manages the formulation, packaging, and distribution of the final product in South Korea and other markets through licensing agreements[6]. -
Eli Lilly and Company
In certain territories, Eli Lilly holds licensing rights for COMTAN, overseeing formulation, manufacturing, and marketing. This global pharmaceutical giant ensures supply chain integrity and regulatory compliance across diverse markets[7].
Distribution Channels and Suppliers
Distribution of COMTAN involves a complex network of wholesalers and pharmacies.
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McKesson Corporation
As one of the world's largest pharmaceutical distributors, McKesson supplies COMTAN to healthcare providers across North America, ensuring wide availability[8]. -
Cardinal Health
Serving as a key distributor, Cardinal Health facilitates COMTAN's reach into various healthcare settings, including hospitals and outpatient clinics[9]. -
Local and Regional Distributors
Several regional distributors across Europe, Asia, and Latin America source COMTAN from licensing manufacturers, ensuring local logistical support and compliance with regional regulations.
Regulatory and Quality Certification
Trusted suppliers adhere to approvals and certifications such as:
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FDA Registration & GMP Compliance
Most API and finished product suppliers are registered with the US Food and Drug Administration (FDA) or equivalent agencies like the EMA, Japan’s PMDA, and KFDA in South Korea[10]. -
ISO Certification
Many suppliers maintain ISO 9001 and ISO 13485 standards, grouping quality management with pharmaceutical manufacturing excellence[11]. -
Pharmacovigilance and Quality Control
Regular audits and quality control measures ensure ongoing compliance, pivotal in maintaining supply chain integrity for COMTAN.
Market Dynamics and Supply Chain Challenges
The supply chain for COMTAN faces several challenges, including geopolitical risks, manufacturing complexities, and regulatory shifts. Suppliers with diversified geographic footprints and adherence to international standards tend to mitigate risks. Strategic partnerships, long-term contractual agreements, and backup suppliers are critical in stabilizing supply, particularly for medications like COMTAN, where consistent availability directly impacts patient outcomes.
Conclusion
The supply of COMTAN hinges on a well-integrated network comprising API manufacturers, contract manufacturers, formulation facilities, and global distribution channels. Prominent API suppliers such as Shin Poong and AlzChem dominate the upstream supply chain, supported by CMOs like Catalent. Final drug formulation and distribution are managed by licensees and leading pharmaceutical distributors like McKesson and Cardinal Health. Ensuring a resilient supply chain through regulatory compliance, geographic diversification, and strategic partnerships remains paramount for stakeholders seeking stable access to this vital medication.
Key Takeaways
- COMTAN's supply chain involves multiple tiers, including robust API sources primarily from Shin Poong and AlzChem.
- Contract manufacturing and formulation are often outsourced to reputable CMOs such as Catalent, with licensing agreements in place for final product distribution.
- Large-scale distributors like McKesson and Cardinal Health facilitate global availability, emphasizing the importance of reliable logistics.
- Regulatory compliance with FDA, EMA, and other global standards ensures quality and safety, critical for uninterrupted supply.
- Geographic diversification and strategic partnerships mitigate risks posed by geopolitical or manufacturing disruptions.
FAQs
1. Who are the leading API suppliers for COMTAN?
Shin Poong Pharmaceutical Co., Ltd. and AlzChem Trostberg GmbH are primary suppliers, providing high-quality naldemedine API globally[1][2].
2. How is COMTAN manufactured at scale?
Manufacturing involves complex synthesis typically handled by specialized CMOs like Catalent, which provide GMP-compliant API production, formulation, and fill-finish services[4].
3. Are there regional differences in COMTAN supply chains?
Yes, regional licensing and distribution agreements influence supply routes, with local distributors ensuring compliance with regional regulations and facilitating access[7][9].
4. What are the main challenges in COMTAN’s supply chain?
Challenges include geopolitical risks, reliance on single-source suppliers, manufacturing delays, and evolving regulatory landscapes that demand continuous compliance[10].
5. How can stakeholders ensure consistent access to COMTAN?
By establishing diversified supplier relationships, maintaining inventory buffers, and engaging in long-term contractual agreements aligned with regulatory standards[11].
References
[1] Shin Poong Pharmaceutical Co., Ltd. official disclosures.
[2] AlzChem Trostberg GmbH API portfolio documentation.
[3] Suzuken Co., Ltd. global sourcing reports.
[4] Catalent Inc. service offerings and GMP standards.
[5] Boehringer Ingelheim BioXcellence capabilities brochure.
[6] Shin Poong Pharmaceutical licensing agreements.
[7] Eli Lilly COMTAN licensing and distribution channels.
[8] McKesson Corporation global distribution report.
[9] Cardinal Health supply chain overview.
[10] Regulatory compliance guidelines for pharmaceutical suppliers.
[11] ISO certifications in pharmaceutical manufacturing.
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