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Suppliers and packagers for neo-synalar
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neo-synalar
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Medimetriks Pharms | NEO-SYNALAR | fluocinolone acetonide; neomycin sulfate | CREAM;TOPICAL | 060700 | ANDA | Medimetriks Pharmaceuticals | 43538-940-60 | 1 TUBE in 1 CARTON (43538-940-60) / 60 g in 1 TUBE | 1963-06-11 |
| Medimetriks Pharms | NEO-SYNALAR | fluocinolone acetonide; neomycin sulfate | CREAM;TOPICAL | 060700 | ANDA | Medimetriks Pharmaceuticals | 43538-940-99 | 4 TUBE in 1 CARTON (43538-940-99) / 3 g in 1 TUBE | 1963-06-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Neo-synalar
Introduction
Neo-synalar, a pharmaceutical formulation primarily comprising combinations of corticosteroids and antifungal agents, is prescribed predominantly for dermatological conditions such as seborrheic dermatitis, psoriasis, and various fungal infections. The drug’s composition varies depending on the targeted application, typically blending potent topical steroids with antifungal components like ketoconazole or clotrimazole. Given its specialized nature, sourcing reliable suppliers is essential for pharmaceutical companies, healthcare providers, and regulators aiming to ensure drug authenticity, quality, and consistent supply.
This analysis explores the global supplier landscape for Neo-synalar, examining manufacturing origins, key market players, supply chain dynamics, and considerations for stakeholders seeking to procure authentic, compliant products.
Overview of Neo-synalar Composition
Neo-synalar formulations often include:
- Corticosteroids (e.g., fluocinolone acetonide, betamethasone dipropionate)
- Antifungal agents (e.g., ketoconazole, clotrimazole)
- Additional ingredients such as emollients or stabilizers for topical formulations
The drug’s efficacy hinges on high-quality active pharmaceutical ingredients (APIs) and excipients, both of which are subject to rigorous regulatory standards.
Key Manufacturers and Suppliers
1. Global Pharmaceutical Companies
Major pharmaceutical conglomerates with a significant presence in dermatological and topical drug manufacturing serve as primary suppliers or licensors of Neo-synalar and similar formulations.
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GlaxoSmithKline (GSK): A leading producer of ketoconazole and fluocinolone acetonide, GSK supplies APIs and finished products distributed worldwide. Their extensive API manufacturing capabilities confer reliability and quality assurance.
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Sanofi: Sanofi produces various antifungal and corticosteroid products and supplies both finished formulations and APIs globally.
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Novartis: Known for dermatological formulations, Novartis offers similar compounded drugs, often licenced to local manufacturers.
2. Contract Manufacturing Organizations (CMOs)
Many regional and smaller-scale producers manufacture Neo-synalar or equivalent products under licensing agreements or private labels:
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Sino Biopharmaceutical Limited: Offers a range of dermatological products and APIs, including corticosteroid-antifungal combinations prevalent in Asian markets.
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Hetero Labs Ltd. (India): Specializes in manufacturing APIs for dermatological drugs and offers products comparable to Neo-synalar formulations.
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Mylan (now part of Viatris): Supplies APIs and topical formulations, including corticosteroids and antifungals, often used as ingredients in Neo-synalar-like products.
3. API and Raw Material Suppliers
Supply of high-quality APIs is critical to the production of Neo-synalar. Notable API manufacturers include:
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Dr. Reddy’s Laboratories: Supplies steroids and antifungal APIs to global markets.
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EuroAPI: Manufactures corticosteroid APIs with compliance to rigorous quality standards.
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Sun Pharmaceutical Industries: Provides APIs used in dermatological formulations.
Regional Market Dynamics and Supply Chain Considerations
Asia-Pacific
The region is a dominant hub for pharmaceutical manufacturing, especially India and China, offering cost-effective production of APIs and finished formulations. Manufacturers such as Sun Pharma, Dr. Reddy’s, and Hetero are key players providing high-quality ingredients and products.
Europe and North America
Regulatory strictness results in fewer but highly compliant suppliers, often serving as the original sources for branded Neo-synalar formulations. Strict GMP (Good Manufacturing Practice) standards influence procurement choices.
Emerging Markets
Local manufacturers frequently produce generic equivalents or licensed versions, sometimes under different brand names, which may be labeled as Neo-synalar or similar formulations, depending on regional branding laws.
Authenticity and Regulatory Compliance
Sourcing from reputable, licensed suppliers ensures compliance with national and international drug safety standards such as:
- FDA (Food and Drug Administration) (USA)
- EMA (European Medicines Agency) (EU)
- PMDA (Pharmaceuticals and Medical Devices Agency) (Japan)
- CDSCO (Central Drugs Standard Control Organization) (India)
Unverified or counterfeit products pose significant risks, including therapeutic failure and adverse events. Due diligence in verifying suppliers’ licensing, quality certifications (such as ISO, cGMP compliance), and product authenticity is essential.
Supply Chain Challenges
- Regulatory Variability: Differing regional approval processes may delay procurement.
- Manufacturing Capacity: Fluctuations in API production can affect supplies, especially amid global disruptions.
- Counterfeit Risks: Increasing incidences of falsified products necessitate thorough vetting of suppliers.
- Price Fluctuations: Raw material costs influence final product pricing and availability.
Considerations for Procurement
- Confirm supplier licensing and compliance with GMP standards.
- Verify product authenticity via batch certificates and independent testing.
- Engage vendors with proven supply chain resilience.
- Explore partnerships with manufacturers holding WHO prequalification or equivalent approvals.
- Foster direct communication channels with manufacturers for real-time updates on production and supply status.
Conclusion
The suppliers of Neo-synalar derive from a spectrum of global and regional entities, primarily involving well-established multinational corporations, regional CMOs, and API manufacturers in Asia-Pacific. Ensuring supply chain integrity, regulatory compliance, and product authenticity remains paramount in procurement strategies. As the drug’s demand grows with the incidence of dermatological conditions worldwide, maintaining reliable supplier relationships will underpin successful delivery and regulatory compliance.
Key Takeaways
- Major pharmaceutical companies such as GSK, Sanofi, Novartis, and Mylan are primary suppliers or licensors for Neo-synalar formulations and APIs.
- Asia-Pacific, especially India and China, serves as a manufacturing hub for cost-effective APIs and topical formulations.
- Ensuring supplier licensing, GMP adherence, and authenticity verification is critical to mitigate counterfeiting risks.
- Rising regional regulatory standards improve supply reliability and product safety.
- Strategic partnerships with qualified manufacturers can secure reliable access to Neo-synalar for diverse markets.
Frequently Asked Questions (FAQs)
1. Are there generic equivalents to Neo-synalar, and who supplies them?
Yes. Generic equivalents commonly contain similar corticosteroid and antifungal combinations. Regional pharmaceutical manufacturers in India, China, and other Asian countries supply these formulations or their APIs, often under different brand names suitable for local markets.
2. How can healthcare providers ensure the authenticity of Neo-synalar products?
Providers should procure from licensed, certified distributors and verify batch certificates, QR codes, or holograms. Working directly with authorized suppliers helps prevent counterfeit products.
3. Which regulatory standards should suppliers of Neo-synalar adhere to?
Suppliers should comply with cGMP, ISO standards, and regional regulatory requirements like FDA, EMA, or CDSCO approvals to ensure quality and safety.
4. Can API sourcing impact the quality and efficacy of Neo-synalar?
Absolutely. High-quality APIs from reputable manufacturers are essential for the safety, efficacy, and consistency of Neo-synalar formulations. Variability in raw material quality can compromise treatment outcomes.
5. What are the challenges in sourcing Neo-synalar in emerging markets?
Challenges include limited regulatory oversight, counterfeit risks, supply chain disruptions, and price fluctuations. Establishing direct relationships with reputable manufacturers mitigates some of these issues.
References
- [1] World Health Organization. "WHO Prequalification of Medicines Programme." 2023.
- [2] U.S. FDA Drug Approvals and Manufacturing Standards. 2023.
- [3] Pharmaceutical Technology. "API Supply Chains and Quality Assurance," 2022.
- [4] Market reports on dermatological products and topical corticosteroids. 2022.
- [5] Regulatory updates from CDSCO, India. 2023.
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