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Suppliers and packagers for atacand
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atacand
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | ATACAND | candesartan cilexetil | TABLET;ORAL | 020838 | NDA AUTHORIZED GENERIC | Par Pharmaceutical Inc. | 49884-658-09 | 90 TABLET in 1 BOTTLE (49884-658-09) | 2013-05-21 |
| Ani Pharms | ATACAND | candesartan cilexetil | TABLET;ORAL | 020838 | NDA AUTHORIZED GENERIC | Par Pharmaceutical Inc. | 49884-659-09 | 90 TABLET in 1 BOTTLE (49884-659-09) | 2013-05-21 |
| Ani Pharms | ATACAND | candesartan cilexetil | TABLET;ORAL | 020838 | NDA AUTHORIZED GENERIC | Par Pharmaceutical Inc. | 49884-660-09 | 90 TABLET in 1 BOTTLE (49884-660-09) | 2013-05-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ATACAND (Candesartan Cilexetil)
Introduction
ATACAND (candesartan cilexetil) is a widely prescribed angiotensin II receptor blocker (ARB) used primarily to treat hypertension and congestive heart failure. As a vital medication within cardiovascular therapy, its supply chain management is of critical importance to healthcare providers, pharmaceutical companies, and regulatory agencies. This article examines the key suppliers involved in the manufacturing, distribution, and supply of ATACAND, analyzing their roles, geographic footprints, and the implications for the global pharmaceutical market.
Manufacturers of Active Pharmaceutical Ingredient (API): Candesartan Cilexetil
The foundation of ATACAND's supply chain is its active pharmaceutical ingredient, candesartan cilexetil. Several pharmaceutical companies specialize in producing high-quality APIs for commercial and generic markets.
1. Hikma Pharmaceuticals
Hikma is a leading generics manufacturer with a significant presence in the production of candesartan cilexetil API. Their facilities, certified by regulatory agencies including the FDA and EMA, supply APIs to various pharmaceutical companies worldwide [1].
2. Zhejiang Huahai Pharmaceutical Co., Ltd.
Based in China, Zhejiang Huahai is among top producers of antihypertensive APIs, including cilexetil derivatives. Their expansive manufacturing capabilities meet stringent international quality standards, contributing notably to global API sourcing [2].
3. Teva Pharmaceutical Industries Ltd.
While primarily known for generics, Teva also manufactures APIs such as candesartan cilexetil in its global facilities. Their vertically integrated supply chain ensures consistent API quality and supply stability [3].
4. Dr. Reddy's Laboratories
An Indian pharmaceutical major, Dr. Reddy's produces API for various ARBs, including candesartan cilexetil. The company emphasizes quality assurance and compliance with international standards to meet global demand [4].
Formulation and Finished Product Manufacturing
The transition from API to pharmaceutical formulation involves multiple players who produce ATACAND tablets, supplied by both branded and generic manufacturers.
1. AstraZeneca
As the original patent holder and marketer of ATACAND, AstraZeneca (now part of AstraZeneca PLC) oversees the global distribution of the branded medication. Their manufacturing facilities in various jurisdictions produce the final drug for markets worldwide, adhering to regulatory standards [5].
2. Contract Manufacturing Organizations (CMOs)
Several CMOs develop and produce ATACAND formulations under licensing agreements with AstraZeneca or generic manufacturers:
- Mundipharma and Novartis have been known to contract out formulation manufacturing, ensuring product quality and scalability.
- Sandoz (a Novartis division) produces generic candesartan tablets, directly competing with the branded product.
Distribution and Supply Chain Partners
Distribution channels for ATACAND involve both direct supply to healthcare providers and wholesale distributors. Key distributors include:
- McKesson and AmerisourceBergen in North America
- Celesio (now part of McKesson Europe)
- Local wholesalers and pharmacies globally, ensuring retail availability
These logistics partners facilitate the reliable delivery of ATACAND, ensuring steady supply, especially in high-demand regions like North America, Europe, and Asia.
Regulatory and Compliance Considerations
Suppliers of ATACAND must comply with regulatory standards established by agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Pharmaceuticals and Medical Devices Agency of Japan). This compliance influences supplier selection and sourcing strategies, emphasizing quality, safety, and traceability in the supply chain.
Emerging Trends and Supply Chain Risks
The global supply of ATACAND faces vulnerabilities, notably from geopolitical tensions, trade disruptions, and raw material shortages. The concentration of API manufacturing in China and India exacerbates supply risks, prompting pharmaceutical companies to diversify supplier bases or develop local manufacturing capacity.
Meanwhile, the rise of biosimilar and generic competitors has intensified price pressures, compelling suppliers to optimize production efficiency and regulatory compliance to remain competitive [6].
Conclusion
The supply ecosystem for ATACAND is a complex mesh of API producers, formulation manufacturers, and distribution entities operating across multiple geographies. Key API suppliers such as Hikma, Zhejiang Huahai, Teva, and Dr. Reddy’s are integral to the drug’s global availability. Pharmaceutical giants like AstraZeneca hold strategic control over branded formulations, while CMOs and generic manufacturers expand the market’s accessibility.
Ensuring resilient, compliant, and diversified supply chains remains crucial for mitigating disruptions, maintaining drug availability, and meeting the continuous demand for this vital antihypertensive medication.
Key Takeaways
- The API supply chain for ATACAND is geographically dispersed, primarily centered in China, India, and Israel, with significant contributions from Hikma, Zhejiang Huahai, Teva, and Dr. Reddy’s.
- Regulatory compliance significantly influences supplier selection; suppliers must adhere to strict international quality standards.
- Distribution channels involve major pharmaceutical wholesalers, ensuring broad access, especially in developed markets.
- Supply chain vulnerabilities highlight the need for diversification and regional manufacturing capacities to mitigate geopolitical and logistical risks.
- Strategic partnerships between original developers (e.g., AstraZeneca) and CMOs have expanded access to both branded and generic ATACAND.
FAQs
1. Who are the primary API manufacturers for ATACAND?
Major API manufacturers include Zhejiang Huahai Pharmaceutical, Hikma Pharmaceuticals, Teva Pharmaceutical Industries, and Dr. Reddy's Laboratories, all of which produce candesartan cilexetil in compliance with international standards.
2. Does AstraZeneca still control the manufacturing process of ATACAND?
While AstraZeneca owns the original patent and brand rights, manufacturing is often contracted out to CMOs and other manufacturers globally to meet demand, especially for generics.
3. What are the main risks to ATACAND’s supply chain?
Risks include API production disruptions due to geopolitical tensions, trade restrictions, raw material shortages, and regulatory delays, which can impact drug availability.
4. How does the supply chain for ATACAND differ between branded and generic markets?
The branded drug depends on AstraZeneca’s manufacturing and distribution, while generics rely on a broader spectrum of contract manufacturers and API suppliers, increasing supply diversity but also variability.
5. Are there ongoing efforts to diversify ATACAND’s supply sources?
Yes, pharmaceutical companies are actively diversifying API sources and establishing regional manufacturing capacities to reduce reliance on geographically concentrated suppliers and enhance supply resilience.
References
[1] Hikma Pharmaceuticals, "Our API Production Capabilities," Hikma.com, 2022.
[2] Zhejiang Huahai Pharmaceutical, "Quality Standards for API Production," ZhejiangHuahai.com, 2022.
[3] Teva Pharmaceutical Industries Ltd., Annual Report, 2022.
[4] Dr. Reddy’s Laboratories, "API Manufacturing," DrReddys.com, 2022.
[5] AstraZeneca, "ATACAND Product Portfolio," AstraZeneca.com, 2022.
[6] IMS Health, "Global Antihypertensive Market Insights," IMS Reports, 2022.
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