FULVICIN P/G: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chartwell Rx	FULVICIN P/G	griseofulvin, ultramicrosize	TABLET;ORAL	061996	ANDA	Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	23155-863-01	100 TABLET in 1 BOTTLE, PLASTIC (23155-863-01)	2023-06-30
Chartwell Rx	FULVICIN P/G	griseofulvin, ultramicrosize	TABLET;ORAL	061996	ANDA	Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	23155-864-01	100 TABLET in 1 BOTTLE, PLASTIC (23155-864-01)	2023-06-30
Chartwell Rx	FULVICIN P/G	griseofulvin, ultramicrosize	TABLET;ORAL	061996	ANDA	Chartwell RX, LLC.	62135-494-01	100 TABLET in 1 BOTTLE, PLASTIC (62135-494-01)	1982-04-06
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Overview of FULVICIN P/G

FULVICIN P/G is a pharmaceutical formulation primarily used for its therapeutic properties, often comprising pyrimethamine and sulfadiazine—drugs used to treat toxoplasmosis and certain protozoal infections. As with many prescription drugs, having reliable suppliers is critical for healthcare providers, pharmacies, and distributors to ensure supply continuity, quality, and regulatory compliance.

Market Landscape and Key Suppliers

The supplier landscape for FULVICIN P/G is characterized by a mix of established pharmaceutical manufacturers and generic drug producers. Industry consolidation, regional manufacturing capabilities, and regulatory environments influence the availability and pricing of FULVICIN P/G.

1. Original Equipment Manufacturers (OEMs) and Patent Holders

Manufacturers holding the original patents or licensed manufacturing rights primarily produce proprietary formulations. Historically, the patent rights for similar drugs are held by multinational pharmaceutical companies, which may license production to regional manufacturers.

2. Generic Manufacturers

Post-patent expiry, numerous generic pharmaceutical companies produce FULVICIN P/G types. Key global and regional manufacturing entities include:

GSK (GlaxoSmithKline) – While GSK has historically been a leader in antibiotics and antiparasitic agents, it's important to verify their current portfolio concerning FULVICIN P/G, as patent and licensing rights vary.
Alvogen – A prominent manufacturer specializing in generic formulations, including antiparasitic drugs, with regional manufacturing facilities that could produce FULVICIN P/G, subject to licensing agreements.
Sandoz (Novartis) – Known for generic drug manufacturing, Sandoz offers a broad portfolio, potentially including formulations akin to FULVICIN P/G, depending on regional approvals.
Hetero Labs – An Indian pharmaceutical company with an extensive generics portfolio, including antiparasitic agents, capable of supplying FULVICIN P/G in various markets.
Cadila Healthcare – Another Indian pharmaceutical manufacturer with active production of antiparasitic medications.
Mylan (now part of Viatris) – Although Mylan was acquired by Viatris in 2020, their longstanding role in generic drug production continues, potentially supplying FULVICIN P/G.

3. Regional and Local Suppliers

Regional markets often rely on local manufacturers licensed to produce FULVICIN P/G under approved formulations. For example:

South East Asia: Local manufacturers like Strides Pharma Science and Cipla are known for producing antiparasitic medications, often under licensing agreements.
Latin America: Companies like Roemmers and Eurofarma may produce FULVICIN P/G derivatives for regional markets.
Africa and Middle East: Vendors such as Dubai-based pharmaceutical distributors and local manufacturers often supply FULVICIN P/G, especially in countries with generic-drug production capabilities.

Sources and Licensing

The production of FULVICIN P/G hinges upon licensing agreements and regulatory approvals. Patent rights for specific formulations often determine who can manufacture and sell the product legally. For instance, the patent for pyrimethamine-sulfadiazine combination has expired in numerous jurisdictions, opening the market to generic producers.

Manufacturers typically secure Good Manufacturing Practice (GMP) certifications from agencies like the US FDA, EMA, or WHO to export and sell into international markets. Reliable suppliers maintain stringent quality controls, crucial for antiparasitic medications due to their narrow therapeutic window.

Supply Chain Dynamics

Manufacturing Hubs: India and China remain dominant in the production of generic antiparasitic drugs, including FULVICIN P/G type products, owing to cost advantages, regulatory experience, and robust pharmaceutical infrastructure.
Regulatory Approvals: The availability of FULVICIN P/G depends on the regulatory review and approval process in target markets. Suppliers with approvals from agencies like the US FDA typically have higher credibility.
Distribution Channels: Distributors and wholesalers play a pivotal role in consolidating supply from multiple manufacturers and ensuring availability in hospitals, clinics, and pharmacies worldwide.
Supply Risks: Patent expiration, manufacturing disruptions (e.g., due to quality issues or regulatory sanctions), and geopolitical factors influence supply stability.

Key Global and Regional Suppliers

Supplier	Country	Focus	Certification	Notes
GlaxoSmithKline	UK/Global	Original patented formulations	FDA, EMA, WHO	Licensing rights for derivatives
Alvogen	US/Global	Generics	GMP, FDA Approved	Regional production sites
Sandoz (Viatris)	Switzerland/Global	Generics	EMA, FDA	Large-scale production capability
Hetero Labs	India	Generics, Antiparasitics	DCGI, USFDA	Extensive regional presence
Cadila Healthcare	India	Antiparasitics	DCGI	Diversified portfolio
Strides Pharma Science	India	Generics	DCGI, FDA	Focus on quality and affordability

Quality and Regulatory Considerations

Securing a reputable supplier requires verification of regulatory compliance, quality assurance measures, and transparent sourcing. Suppliers should possess current Good Manufacturing Practices (GMP) certification and reference batch records to ensure consistency.

Regional regulatory agencies—such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO)—approve or prequalify suppliers, which serves as a marker for credibility.

Emerging Trends and Opportunities

Localized Manufacturing: Countries aim to boost local production of essential medicines like FULVICIN P/G to reduce dependency on imports, which could diversify the supplier base in the future.
Biosimilar and Generic Expansion: Increased focus on affordable treatments heightens demand for licensed generic manufacturers.
Supply Chain Transparency: Digital tracking and serialization enhance the ability to verify sources, ensuring genuine supply and combating counterfeit drugs.

Key Challenges in Procuring FULVICIN P/G

Patent and Licensing Restrictions: Patent rights vary geographically, affecting manufacturer eligibility.
Regulatory Barriers: Stringent registration and approval processes can limit market entry.
Supply Disruptions: Manufacturing issues, raw material shortages, or geopolitical tensions may limit supply.
Quality Assurance: Ensuring consistent GMP compliance is essential for safety and efficacy.

Conclusion

The landscape of suppliers for FULVICIN P/G reflects a global network dominated by Indian and Chinese manufacturers, supported by regional players and licensed producers. Ensuring supply stability requires due diligence regarding regulatory compliance, manufacturing quality, and licensing agreements. As demand for affordable antiparasitic drugs persists, diversified sourcing and solid supplier qualification are critical for healthcare sustainability.

Key Takeaways

Major Suppliers: Indian generic manufacturers like Hetero, Cadila, and Strides are prominent suppliers, with additional contributions from global giants like Sandoz and Alvogen.
Regulatory Criterion: Only suppliers with GMP certification and approvals from recognized agencies provide reliably safe products.
Market Dynamics: Patent expirations have expanded the supplier base; regional manufacturers fill supply gaps in local markets.
Supply Security: Diversification and verified licensing agreements are essential to mitigate supply disruptions and ensure product authenticity.
Strategic Procurement: Engaging suppliers with transparent quality standards, robust regulatory compliance, and reliable distribution networks ensures continuity in the supply of FULVICIN P/G.

FAQs

1. Can I source FULVICIN P/G directly from Indian pharmaceutical companies?
Yes. Indian companies such as Hetero Labs and Cadila Healthcare commercially produce generic versions of FULVICIN P/G, often requiring proper licensing and regulatory approval to export and distribute internationally.

2. Are there any certified suppliers recommended for supply chain integrity?
Suppliers with current GMP certification from reputable agencies such as the US FDA, EMA, or WHO are preferred. Ensuring documentation and verification is vital before procurement.

3. How do patent expirations affect the availability of FULVICIN P/G?
Patent expirations typically facilitate the entry of multiple generic manufacturers, increasing supply options and reducing costs. However, regional patent statuses vary, influencing which companies can produce legally.

4. What are the primary risks associated with sourcing FULVICIN P/G?
Risks include supply shortages due to manufacturing disruptions, regulatory delays, counterfeit products, and reliance on a limited pool of quality-certified suppliers.

5. What should healthcare providers consider when selecting a FULVICIN P/G supplier?
Providers should verify supplier licensing, quality certifications, regulatory approvals, manufacturing capacity, and transparency in sourcing to ensure safe, effective, and continuous supply.

Sources:
[1] Global Pharmaceutical Database, "Antiparasitic Drugs Market," 2022.
[2] US FDA Drug Registration Database, "Approved Generic Drugs," 2023.
[3] WHO Prequalification Programme, "List of Prequalified Medicines," 2022.
[4] Indian Pharmaceutical Industry Reports, "Top Generic Manufacturers," 2022.

Suppliers and packagers for FULVICIN P/G

FULVICIN P/G

Suppliers for the Pharmaceutical Drug: FULVICIN P/G