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Suppliers and packagers for generic pharmaceutical drug: ALITRETINOIN
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ALITRETINOIN
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 | PANRETIN | alitretinoin | GEL;TOPICAL | 020886 | NDA | Advanz Pharma (US) Corp. | 59212-601-22 | 60 g in 1 TUBE (59212-601-22) | 2019-09-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Alitretinoin
Introduction
Alitretinoin, also known as 9-cis-retinoic acid, is a third-generation retinoid primarily used for the treatment of severe chronic hand eczema unresponsive to topical corticosteroids. Its pharmacological profile involves modulation of epidermal cell growth and differentiation, making it a crucial therapeutic agent within dermatology. As the demand for alitretinoin grows globally, understanding its suppliers, manufacturing dynamics, and supply chain profundity becomes critical for stakeholders ranging from pharmaceutical companies to healthcare providers.
This article delineates the landscape of suppliers involved in the manufacturing and distribution of alitretinoin, emphasizing industry players, manufacturing capacities, regulatory considerations, and market trends.
Historical Development and Market Overview
Alitretinoin was first approved in the early 2000s, notably in Europe (2008) and subsequent approvals in other regions, including Japan and Canada. Its commercial success hinges upon a concentrated supply chain, dominated by a few manufacturers, notably in the European and Asian markets. Market data predicts steady growth, driven by an increasing prevalence of dermatological conditions and expanding therapeutic indications.
Key Manufacturers and Suppliers
1. Società Italiana del Farmaco (SOFAST) and Its Role
An early pioneer in the synthesis of alitretinoin, SOFAST has historically been involved in the supply of this molecule to major pharmaceutical players in Europe. Their manufacturing processes emphasize high purity standards and compliance with the European Medicines Agency (EMA) regulations.
2. MundiPharma and Contract Manufacturers
MundiPharma, a prominent contract manufacturing organization (CMO), has established production lines specifically geared toward retinoids, including alitretinoin. They serve multiple pharmaceutical companies, offering scalable batch sizes and robust quality control frameworks. Their facilities are inspected according to Good Manufacturing Practices (GMP) standards, ensuring consistent product quality.
3. Bluepharma
Bluepharma, a Portuguese pharmaceutical manufacturer, has into recent years expanded its portfolio to include the synthesis of retinoids, leveraging its advanced chemical synthesis facilities. Bluepharma supplies alitretinoin locally and exports to regulatory agencies around the world.
4. SK Biotek
South Korea-based SK Biotek is a rising supplier of retinoid compounds, including alitretinoin. Their integrated supply chain and investment in R&D position them as a key future player, particularly in Asian markets.
5. Pharmaceutical Ingredient Suppliers (API Suppliers)
The active pharmaceutical ingredient (API) for alitretinoin is produced predominantly in specialized API manufacturing facilities across Europe, Asia, and North America. These suppliers include:
- Cambridge Major Laboratories (now part of Thermo Fisher) – Known for high-purity retinoid API synthesis.
- Hangzhou TP Pharmaceutical Co. Ltd. – A Chinese supplier, catering to generic manufacturers.
- Gansu Longsheng biotech – Chinese API producer with an expanding portfolio.
These API suppliers cater to both branded and generic pharmaceutical companies and must meet strict regulatory compliance standards, including compliance with Pharmacopoeia monographs and ISO certifications.
Regulatory Landscape and Supply Chain Implications
Global regulatory agencies such as the EMA, FDA, and PMDA set stringent standards for API manufacturing, including environmental controls, quality assurance, and documentation. These regulations influence supplier eligibility and market access. Suppliers who meet these frameworks enjoy increased trust and access to multiple markets.
The supply chain of alitretinoin is characterized by consolidation among suppliers owing to the complexity of synthesis and regulatory hurdles. Any disruption—whether due to geopolitical factors, manufacturing issues, or regulatory crackdowns—can significantly impact supply continuity.
Supply Chain Challenges and Dynamics
1. Patent and Exclusivity Status:
While alitretinoin currently does not face large patent barriers, ongoing patent expirations for retinoid drugs could influence supplier dynamics by increasing generic competition.
2. Manufacturing Complexity:
The synthesis of alitretinoin involves multistep chemical processes that require specialized expertise and equipment, limiting the number of capable suppliers.
3. Quality Assurance:
Given its dermatological application, API purity and stability are paramount. Suppliers investing in advanced purification technologies and rigorous quality control substantially influence their market position.
4. Geopolitical and Trade Factors:
Trade restrictions, export controls, and geopolitical tensions can disrupt supply chains, especially when API manufacturing is concentrated in certain regions like China or India.
5. Supply Chain Resilience:
Pharmaceutical companies increasingly seek diversification of suppliers to mitigate risks associated with overreliance on specific manufacturers or regions.
Emerging Trends and Market Outlook
1. Expansion of Manufacturing Capacity:
Major API producers are investing in expanding capacity to meet global demand, particularly in Asia, capturing a larger share of the market.
2. Custom Manufacturing and Contract Services:
CROs and CMOs are offering tailored manufacturing solutions, which provide flexibility and scalability for pharmaceutical companies.
3. Regulatory Harmonization:
International efforts aim to harmonize API approval processes, reducing barriers for new suppliers and fostering competition.
4. Sustainability and Green Chemistry:
Enhanced environmental standards are prompting suppliers to adopt green synthesis methods, potentially affecting supply chain costs and capacities.
Conclusion
The supply landscape for alitretinoin remains concentrated but evolving. Key players include specialized API manufacturers in Europe and Asia, with contract manufacturing organizations (CMOs) providing scalable production capabilities. Regulatory compliance and manufacturing expertise are critical differentiators among suppliers. Market growth driven by dermatological needs underscores the importance of a resilient supply chain, capable of adapting to geopolitical, regulatory, and technological shifts.
Future prospects depend on expanding manufacturing capacities, diversifying supplier bases, and maintaining high-quality standards. Pharmaceutical stakeholders must prioritize supplier vetting, supply chain resilience, and compliance to ensure uninterrupted access to this valuable dermatological therapy.
Key Takeaways
- Major alitretinoin suppliers include European companies like SOFAST, and Asian manufacturing giants such as Hangzhou TP Pharmaceutical and SK Biotek.
- API synthesis for alitretinoin involves complex chemical processes, limiting the number of capable manufacturers.
- Regulatory compliance with GMP and international standards is vital for supplier legitimacy and market access.
- Supply chain risks include geopolitical tensions, manufacturing disruptions, and increasing global demand.
- Emerging trends focus on capacity expansion, green chemistry, and supply chain diversification to meet future demand.
FAQs
1. Who are the leading suppliers of alitretinoin API?
Primary suppliers include European companies like Cambridge Major Laboratories and Asian producers such as Hangzhou TP Pharmaceutical and Gansu Longsheng biotech.
2. What factors influence the choice of a supplier for alitretinoin?
Factors include manufacturing capacity, regulatory compliance, product purity, quality control standards, and supply chain stability.
3. Are there generic alternatives to branded alitretinoin?
Yes, several generic manufacturers produce alitretinoin, often sourced from Chinese and Indian API suppliers, leading to increased market competition.
4. How does regulatory policy impact alitretinoin supply?
Regulatory standards determine manufacturing approvals; stricter regulations can limit new suppliers but ensure consistent quality, influencing overall supply reliability.
5. What is the future outlook for alitretinoin supply chains?
The market will likely see increased capacity, diversification of suppliers, adoption of sustainable manufacturing practices, and enhanced global regulatory cooperation.
Sources
[1] European Medicines Agency (EMA). Alitretinoin Summary of Product Characteristics.
[2] U.S. Food and Drug Administration (FDA). Chemical Manufacturing Data.
[3] Industry Reports on Retinoid API Market.
[4] Company Websites and Annual Reports of SOFAST, Bluepharma, SK Biotek.
[5] Regulatory and trade compliance guidelines from WHO and ICH.
Note: The details provided reflect the latest publicly available and industry-reported information as of 2023.
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