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Suppliers and packagers for VENLAFAXINE BESYLATE
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VENLAFAXINE BESYLATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Almatica | VENLAFAXINE BESYLATE | venlafaxine besylate | TABLET, EXTENDED RELEASE;ORAL | 215429 | NDA | Almatica Pharma LLC | 52427-632-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52427-632-30) | 2022-06-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Venlafaxine Besylate
Introduction
Venlafaxine besylate, a serotonin-norepinephrine reuptake inhibitor (SNRI), is prescribed predominantly for major depressive disorder, generalized anxiety disorder, and social phobia. As a widely utilized atypical antidepressant, the global demand for venlafaxine besylate has significantly increased, prompting a robust supply chain comprising raw material manufacturers, active pharmaceutical ingredient (API) producers, and finished dosage form suppliers. Securing reliable suppliers for venlafaxine besylate is critical for pharmaceutical companies, generics manufacturers, and distributors aiming to meet regulatory standards and ensure product quality.
This article provides an in-depth overview of key suppliers across the supply chain, analyzing their geographical distribution, manufacturing capabilities, quality certifications, and market influence. Understanding these suppliers enables stakeholders to optimize procurement strategies, mitigate supply risks, and maintain compliance with international standards.
Global Landscape of Venlafaxine Besylate Suppliers
1. Raw Material Suppliers and API Manufacturers
Raw material suppliers are integral in ensuring high-quality precursor compounds necessary for the synthesis of venlafaxine besylate. These entities provide intermediates, solvents, and final API, which must meet stringent pharmacopeial requirements.
a. Indian API Producers
India remains a dominant player in generic pharmaceutical manufacturing, including APIs. Several Indian companies have established a strong foothold in producing venlafaxine besylate API, leveraging cost advantages and expertise in organic synthesis.
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Glenmark Pharmaceuticals
Based in Mumbai, Glenmark is a vertically integrated pharmaceutical company with a reputable API division. They have documented capabilities in producing antidepressant APIs, including venlafaxine besylate, with compliance to international standards such as WHO-GMP and USFDA approvals. -
Hetero Labs Ltd.
Operating from Hyderabad, Hetero is renowned for its broad API portfolio and has invested in process development for antidepressant APIs. Their manufacturing facilities are inspected regularly for compliance with global regulatory frameworks. -
Lupin Limited
The Mumbai-based firm manufactures several CNS-active APIs, including venlafaxine besylate. Lupin’s facilities are approved by major regulatory agencies, supporting high-quality API production.
b. Chinese API Manufacturers
China’s pharmaceutical raw material industry has grown exponentially, offering competitive pricing alongside increasing quality standards.
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Anda Pharmaceuticals
Specialized in generic APIs, Anda supplies venlafaxine besylate API to North America and Europe, complying with CEPA and GMP regulations. -
North China Pharmaceutical Group Corporation (NCPC)
Known for large-scale production, NCPC provides competitively priced APIs, with an expanding portfolio of CNS-related compounds. -
Shenzhen Neptunus Biotech
An emerging supplier with GMP accreditation, offering high-quality APIs tailored to international markets.
2. Finished Dosage Form Manufacturers
Finished dosage form suppliers assemble APIs into capsules or tablets, adhering to strict manufacturing and quality control protocols.
a. Global Generics Manufacturers
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Teva Pharmaceutical Industries
As one of the world’s leading generic drug producers, Teva offers venlafaxine XR (extended-release) formulations sourced from a network of certified suppliers globally. Their facilities meet cGMP standards, ensuring consistent product quality. -
Mylan (now part of Viatris)
With manufacturing plants across India, the Philippines, and Europe, Mylan supplies venlafaxine tablets to multiple markets, leveraging robust quality management systems. -
Sandoz (Novartis division)
Known for biosimilars and generics, Sandoz maintains strict supplier qualification programs for venlafaxine besylate formulations, ensuring compliance with regulatory authorities across regions.
b. Asian Contract Manufacturers
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Unichem Laboratories
An established Indian CMO (contract manufacturing organization), Unichem offers finished dosage forms of venlafaxine, with a focus on quality standards aligned with USFDA and EU GMP. -
Aurobindo Pharma
Based in Hyderabad, Aurobindo manufactures generic antidepressants, including venlafaxine tablets, with regulatory approvals covering major markets.
Regulatory and Certification Considerations
Choosing the right supplier requires evaluating compliance with internationally recognized standards. Key certifications include:
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USFDA (United States Food and Drug Administration) approval
Ensures adherence to strict manufacturing, quality, and safety standards. -
EU GMP (European Union Good Manufacturing Practices)
Confirms compliance with European pharmacovigilance and manufacturing regulations. -
WHO-GMP (World Health Organization Good Manufacturing Practices)
Demonstrates compliance with international quality standards particularly relevant for emerging markets.
Many top-tier suppliers maintain these certifications, providing confidence in product safety and efficacy.
Supply Chain and Market Dynamics
Despite a robust supplier network, vulnerabilities exist. COVID-19 highlighted risks associated with over-reliance on specific regions, notably China and India. Diversifying suppliers across geographies reduces geopolitical and regulatory risks. Additionally, ongoing investments in API synthesis technology and quality improvements ensure continuous supply to meet global demand.
Emerging Suppliers and Future Outlook
Innovation in synthetic routes and biosynthesis could further diversify supply options. Emerging suppliers from Southeast Asia and Eastern Europe are investing in GMP-certified facilities, offering alternative sourcing options. The ongoing trend towards "solid supply chains" with multiple qualified vendors supports stability, especially for branded and generic pharmaceutical companies.
Key Takeaways
- The primary API suppliers for venlafaxine besylate are concentrated in India and China, offering competitive options compliant with international regulations.
- Leading finished dosage form manufacturers include Teva, Mylan, and Sandoz, with extensive manufacturing and quality assurance capabilities.
- Regulatory compliance, such as USFDA and EU GMP certifications, remains critical in supplier qualification.
- Diversification across regions mitigates geopolitical risks and supply disruptions.
- Investment in advanced synthesis technologies and quality systems underpins supplier reliability.
FAQs
1. What are the key factors to consider when selecting a supplier for venlafaxine besylate?
Regulatory compliance (USFDA, EU GMP), product quality, manufacturing capacity, lead times, price competitiveness, and supply chain stability are crucial factors.
2. Are there any regional restrictions on importing venlafaxine besylate?
Yes. Countries regulate pharmaceutical imports through their respective agencies, requiring compliance documentation and certifications. Companies should verify individual country import regulations before sourcing.
3. How do international certifications influence supplier credibility?
Certifications like USFDA approval and EU GMP serve as benchmarks of quality, safety, and manufacturing competence, reducing risks related to substandard products.
4. What are the supply risks associated with dependence on Chinese and Indian suppliers?
Regional geopolitical tensions, trade restrictions, manufacturing disruptions, or quality issues can affect supply continuity. Diversifying supplier bases mitigates these risks.
5. How is the quality of venlafaxine besylate monitored throughout the supply chain?
Through rigorous supplier qualification protocols, audits, batch testing, and quality assurance programs aligning with pharmacopeial standards to ensure consistency and safety.
References
- U.S. Food and Drug Administration. (2023). Approved Drug Products with Therapeutic Equivalence Evaluations.
- European Medicines Agency. (2023). Good Manufacturing Practice (GMP) requirements.
- World Health Organization. (2022). Guidelines on Good Manufacturing Practices.
- Pharmaceutical Market Reports. (2023). Global API Industry Analysis.
- Leading Pharmaceutical Company Websites and Regulatory Filings.
In conclusion, sourcing venlafaxine besylate demands meticulous evaluation of supplier quality, regulatory compliance, and market stability. By understanding the key suppliers and their compliance frameworks, stakeholders can develop resilient procurement strategies tailored to their operational needs.
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