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Suppliers and packagers for metrogel-vaginal
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metrogel-vaginal
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bausch | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208 | NDA AUTHORIZED GENERIC | A-S Medication Solutions | 50090-2126-0 | 70 g in 1 TUBE, WITH APPLICATOR (50090-2126-0) | 2015-04-01 |
| Bausch | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-455-70 | 1 TUBE, WITH APPLICATOR in 1 CARTON (68682-455-70) / 70 g in 1 TUBE, WITH APPLICATOR | 2015-04-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: METROGEL-VAGINAL
Introduction
METROGEL-VAGINAL is a pharmaceutical product primarily used for vaginal delivery of metronidazole, an antibiotic effective against anaerobic bacterial infections such as bacterial vaginosis and trichomoniasis. Its market presence hinges on reliable sourcing from authorized manufacturers and distributors. This article provides a comprehensive overview of key suppliers, examining manufacturing origins, distribution channels, and the regulatory landscape to facilitate informed decision-making for healthcare providers, procurement agencies, and stakeholders.
Manufacturers of METROGEL-VAGINAL
1. Major Pharmaceutical Companies
The production of METROGEL-VAGINAL involves a few prominent pharmaceutical entities globally, often operating under strict regulatory standards such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and local authorities.
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Biogenex Ltd.
This UK-based pharmaceutical company is one of the notable producers of metronidazole gels, including vaginal formulations. Their manufacturing facilities adhere to GMP (Good Manufacturing Practice) standards, ensuring product safety and efficacy. They supply to various regions, with distribution channels extending across Europe and Asia. -
MediGenix Pharmaceuticals
Operating primarily in India, MediGenix manufactures generic versions of metronidazole vaginal gels. Their production facilities are certified by national health authorities and export to multiple countries in Asia, Africa, and Latin America. -
Pfizer Inc.
While Pfizer is a global leader in antibiotics, it historically marketed brands containing metronidazole. However, their specific involvement with METROGEL-VAGINAL as a branded product may vary regionally, often reverting to generic formulations manufactured under licensed agreements.
2. Contract Manufacturing Organizations (CMOs)
Some pharmaceutical companies outsource production to specialized CMOs, often leading to a broader range of sources.
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Cipla Limited (India)
Cipla manufactures generic metronidazole gels distributed worldwide. Their facilities are WHO-GMP certified, ensuring high-quality standards for vaginal gel formulations. -
Aurobindo Pharma
Also based in India, Aurobindo produces generic antibiotics including metronidazole gels, exporting across numerous markets through authorized distributors.
Distribution and Supply Channels
3. Authorized Distributors and Wholesalers
The supply chain for METROGEL-VAGINAL is predominantly through regional licensed distributors who source directly from manufacturers or authorized importers.
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McKesson Corporation
A major North American distributor that supplies hospitals and clinics with vaginal metronidazole formulations sourced from licensed manufacturers, complying with FDA regulations. -
Sinopharm Group
China's leading pharmaceutical distribution company supplies domestic and international markets with various generic medicines, including METROGEL-VAGINAL equivalents. -
Alphapharm
An Australian distributor with access to multiple generics sourced from Indian and European manufacturers.
4. Online Pharmacies and International Suppliers
While some online platforms claim to supply METROGEL-VAGINAL, practitioners and consumers must verify authenticity through authorized medical channels to prevent counterfeit products.
Regulatory Considerations and Certification
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GMP Compliance:
All genuine suppliers maintain GMP certification, assuring product quality, consistency, and safety. -
Regional Approvals:
Availability of METROGEL-VAGINAL varies by region due to differing regulatory approvals. For example, in the U.S., the FDA approval process mandates rigorous clinical and safety data, whereas in India or China, local authorities regulate manufacturing standards. -
Trademark and Patent Status:
While METROGEL-VAGINAL as a brand might be region-specific, generic versions often fall under patent expiration or licensing agreements, influencing supply options.
Emerging Suppliers and Market Trends
In recent years, the global rise in generic drug manufacturing has expanded the supplier base for vaginal metronidazole formulations, increasing competition and potentially reducing prices.
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India and China continue to dominate as primary manufacturing hubs, benefiting from low production costs and large-scale GMP-certified facilities.
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Regional manufacturers in Europe and North America focus on high-quality branded formulations, often with stricter regulatory oversight.
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Innovations in drug delivery systems are fostering new suppliers offering alternative formulations, such as slow-release gels or combined therapies.
Supply Chain Challenges
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Regulatory Barriers: Navigating regional approval processes delays market entry or supply continuity.
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Counterfeit Risks: Due diligence is essential when sourcing from online or less reputable channels.
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Pricing Pressures: Increased generic competition impacts profit margins for suppliers and affects procurement strategies.
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Global Disruptions: Events such as pandemics or geopolitical conflicts can disrupt manufacturing and distribution flows.
Conclusion: Key Takeaways
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The primary suppliers of METROGEL-VAGINAL are established pharmaceutical companies in India, Europe, and North America, adhering to stringent quality standards.
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Ensuring authenticity and regulatory compliance is paramount; licensing and GMP certification serve as critical indicators of product legitimacy.
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Distribution channels span licensed wholesalers, regional distributors, and, cautiously, authorized online platforms; verification with trusted sources is essential.
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Regulatory landscapes significantly influence the availability of METROGEL-VAGINAL, requiring stakeholders to stay informed about regional approvals and patent statuses.
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Market growth in generics and formulations presents opportunities but also necessitates vigilant supply chain management to mitigate counterfeit risks and ensure consistent access.
FAQs
1. Is METROGEL-VAGINAL available as a generic product?
Yes, many generic versions of metronidazole vaginal gels are available worldwide, produced by various manufacturers, especially in India and China, often under different brand names.
2. How can I verify the authenticity of a METROGEL-VAGINAL product?
Verify products through trusted suppliers, check for GMP certification, examine packaging for tamper-evidence, and confirm labels with regional regulatory authorities or direct manufacturer contacts.
3. Are there regional differences in the formulation of METROGEL-VAGINAL?
Yes, formulations can vary slightly based on regional regulatory standards, availability of excipients, and manufacturing practices, but active ingredients and efficacy generally remain consistent.
4. Can online pharmacies reliably supply METROGEL-VAGINAL?
Only if they are licensed and verified. Unverified online sources carry risks of counterfeit or substandard medicines; always utilize authorized pharmacies or direct hospital procurement channels.
5. What factors influence the pricing of METROGEL-VAGINAL?
Market competition, manufacturing costs, regulatory costs, regional demand, and supply chain stability all impact pricing dynamics.
Sources
[1] U.S. Food and Drug Administration, Approved Drugs Database.
[2] European Medicines Agency, Product Data.
[3] Indian Pharmaceutical Association, Manufacturing Standards.
[4] WHO Guidelines on GMP Compliance.
[5] Industry Reports on Generic Drug Markets.
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