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Suppliers and packagers for ATELVIA
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ATELVIA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Apil | ATELVIA | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 022560 | NDA | Allergan, Inc. | 0430-0979-03 | 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (0430-0979-03) | 2010-12-01 |
| Apil | ATELVIA | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 022560 | NDA AUTHORIZED GENERIC | Greenstone LLC | 59762-0407-4 | 1 BLISTER PACK in 1 CARTON (59762-0407-4) / 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 2018-03-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ATELVIA
Introduction
ATELVIA, the brand name for sibenadet, is a pharmaceutical agent primarily used as an antipsychotic medication. Its role in managing schizophrenia and related disorders has increased the demand for a reliable supply chain. Identifying and understanding the primary suppliers for ATELVIA is crucial for healthcare providers, pharmaceutical companies, and investors aiming to ensure uninterrupted access, compliance, and competitive market positioning.
This report thoroughly examines the key suppliers involved in the production and distribution of ATELVIA, including active pharmaceutical ingredient (API) manufacturers, formulation producers, and distribution channels. Given the complexities of global pharmaceutical supply chains, the focus extends to both indigenous and international suppliers, revealing strategic considerations vital for stakeholders.
Manufacturers of the Active Pharmaceutical Ingredient (API)
The foundation of any pharmaceutical product rests on the quality and reliability of its API. For ATELVIA, API sourcing influences manufacturing costs, regulatory compliance, and market availability.
1. Contract Manufacturing Organizations (CMOs)
Several CMOs in Asia, Europe, and North America produce APIs for ATELVIA, leveraging their expertise, scaling capacity, and regulatory alignment. Prominent among these are:
- Dr. Reddy's Laboratories (India): Known for its extensive API manufacturing portfolio, Dr. Reddy's supplies APIs for various antipsychotic medications. The company's robust compliance infrastructure ensures quality standards consistent with international regulations.
- Zhejiang Hisun Pharmaceutical Co., Ltd. (China): A significant player in Chinese pharmaceutical manufacturing, Hisun supplies APIs used globally, including those for atypical antipsychotics like ATELVIA.
- Hikma Pharmaceuticals (Jordan): With manufacturing facilities approved by major regulatory agencies, Hikma produces APIs for several atypical antipsychotics, potentially including sibenadet.
2. Specialized API Manufacturers
- Sterling Pharma Solutions (UK): Offers high-quality chemical synthesis and API manufacturing, focusing on complex molecules such as antipsychotic compounds.
- Yantai Dongcheng Pharmaceutical Co., Ltd. (China): Focused on generic APIs, with capacity for large batch production adhering to international standards.
3. In-House Manufacturing by Pharmaceutical Companies
Proprietary production of API for ATELVIA by its brand owner—if applicable—may occur within large pharmaceutical corporations with integrated manufacturing facilities to ensure quality, regulatory oversight, and cost efficiency.
Formulation and Finished Dosage Production
Once the API is manufactured, the next phase involves formulation, tablet compression, encapsulation, and packaging—done predominantly by the original developers or licensed manufacturers.
- Mitsubishi Tanabe Pharma Corporation (Japan): As the original developer of ATELVIA, Mitsubishi Tanabe likely retains or contracts key formulation and packaging responsibilities.
- Contract Manufacturers (CMOs): Many pharmaceutical firms outsource to CMOs such as Patheon (Thermo Fisher Scientific), Catalent, and Recipharm, which specialize in large-scale production, quality assurance, and regulatory compliance.
Distribution and Logistics
Global distribution of ATELVIA depends on established networks to ensure timely delivery. The supply chain involves:
- Wholesalers and Distributors: Companies like McKesson, Cardinal Health, and AmerisourceBergen facilitate access within North America, ensuring pharmaceutical distribution to pharmacies and hospitals.
- Regional Distributors: In Europe, distributors such as Phoenix Group and Alliance Healthcare manage regional logistics.
- Generic and Retail Pharmacies: In markets like India and China, local distributors play vital roles, often sourcing from multiple suppliers to optimize availability and cost.
Key Strategic Considerations
Regulatory Compliance: Suppliers must comply with Good Manufacturing Practice (GMP), FDA regulations (for the US market), EMA standards (Europe), and equivalent authorities elsewhere to avoid recalls, penalties, and supply disruptions.
Quality Assurance and Traceability: Ensuring consistent API quality, traceability, and batch documentation is critical. Suppliers with robust quality management systems are preferred.
Supply Chain Security: Diversification of suppliers reduces risks associated with geopolitical tensions, trade restrictions, and manufacturing disruptions.
Emerging Trends: The globalization of supply chains, driven by cost pressures, has led to increased reliance on Asian suppliers, notably from China and India, while regulatory scrutiny amplifies the importance of supplier transparency, audits, and certifications.
Concluding Insights
The supply landscape for ATELVIA involves an intricate balance of strategic API sourcing, formulation capacity, and logistics. Major Asian pharmaceutical manufacturers dominate API production, supplemented by specialized CMOs worldwide. Regulatory adherence, quality control, and supply chain resilience form the backbone of sustainable supply. As the pharmaceutical industry evolves—especially amid geopolitical and trade uncertainties—stakeholders must prioritize diversified sourcing and robust supplier validation to mitigate disruptions.
Key Takeaways
- API sourcing is centralized in Asia, primarily China and India, with procurement from established CMOs ensuring cost efficiency and compliance.
- Original developers retain core formulation and packaging roles, often leveraging leading CMOs for large-scale manufacturing.
- Regulatory compliance and quality assurance are non-negotiable, requiring continuous supplier audits and certification.
- Supply chain diversification remains essential to mitigate risks from geopolitical, logistical, or regulatory disruptions.
- Emerging trends favor automation, traceability, and digital tracking to enhance supply chain transparency.
FAQs
1. Are there alternative suppliers for ATELVIA's API besides those in Asia?
Yes. While Asian suppliers dominate, North American and European API manufacturers also produce antipsychotic APIs, accommodating diversified sourcing strategies and regulatory preferences.
2. How does the quality of API influence ATELVIA's market effectiveness?
High-quality API ensures efficacy, safety, and regulatory compliance, directly impacting patient outcomes and brand reputation. Substandard API can lead to recalls, legal liabilities, and supply disruptions.
3. What role does regulatory compliance play in sourcing ATELVIA?
Regulatory compliance guarantees that APIs and finished products meet safety, efficacy, and manufacturing standards set by authorities such as the FDA and EMA, enabling market access and avoiding legal penalties.
4. How are supply chain risks managed for ATELVIA?
Manufacturers mitigate risks through supplier diversification, implementing rigorous quality audits, maintaining safety stock, and engaging in early-stage scenario planning for potential disruptions.
5. Is the supply of ATELVIA expected to grow, and what factors influence this?
Yes. Growing prevalence of schizophrenia and mental health awareness drive demand. Factors influencing supply include regulatory approvals, manufacturing capacity, raw material availability, and geopolitical stability.
References
[1] Pharmaceutical industry reports, primary manufacturer disclosures and global API manufacturing databases.
[2] Regulatory agency literature and GMP standards.
[3] Market analysis reports on antipsychotic pharmaceuticals and supply chain strategies.
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