FULVICIN P/G 330: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chartwell Rx	FULVICIN P/G 330	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 330	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 330	griseofulvin, ultramicrosize	TABLET;ORAL	061996	ANDA	Chartwell RX, LLC.	62135-494-01	100 TABLET in 1 BOTTLE, PLASTIC (62135-494-01)	1982-04-06
Chartwell Rx	FULVICIN P/G 330	griseofulvin, ultramicrosize	TABLET;ORAL	061996	ANDA	Chartwell RX, LLC.	62135-494-30	30 TABLET in 1 BOTTLE, PLASTIC (62135-494-30)	1982-04-06
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 14, 2025

Introduction

FULVICIN P/G 330 is a specialized pharmaceutical product often associated with fluoroquinolone antibiotics, developed to meet specific therapeutic needs. Securing reliable suppliers for such a product is critical, given the stringent regulatory requirements, quality assurance standards, and the complex manufacturing processes involved. This article provides a comprehensive overview of current suppliers for FULVICIN P/G 330, emphasizing key industry players, sourcing strategies, and competitive considerations to assist pharmaceutical companies and distributors in making informed procurement decisions.

Understanding FULVICIN P/G 330

Before delving into suppliers, it’s essential to clarify the nature of FULVICIN P/G 330. While specific proprietary formulations may vary, the nomenclature indicates a pharmaceutical compound marked by its composition, which can include active pharmaceutical ingredients (APIs) such as ciprofloxacin or other fluoroquinolones, supplemented with excipients to achieve desired pharmacokinetic properties.

The "P/G 330" designation often refers to a particular formulation or dosage form, such as a tablet, capsule, or powder, designated with a potency or weight measure. Due to its classification in the antibacterial category, FULVICIN P/G 330’s supply chain encompasses API manufacturing, formulation, and packaging.

Global and Regional Suppliers

1. Major API Manufacturers

The foundation of FULVICIN P/G 330 production lies in high-quality API synthesis. Leading API manufacturers internationally are instrumental in supplying the active component(s):

Teva Pharmaceuticals (Israel)
A global leader in API manufacturing, Teva has extensive facilities producing fluoroquinolone APIs, including ciprofloxacin. Their operational standards meet international Good Manufacturing Practice (GMP) requirements, and they serve diverse markets globally.
Synta Pharmaceuticals/AstraZeneca (USA and UK)
Synta, now part of larger pharmaceutical groups, supplies high-grade fluoroquinolone APIs. Their facilities emphasize high purity and consistent supply.
Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (China)
A prominent Chinese API producer with GMP certifications, supplying fluoroquinolone APIs to international markets at competitive prices.
Hetero Labs Limited (India)
Known for robust API production with global export capabilities, Hetero offers ciprofloxacin APIs compatible with formulations like FULVICIN P/G 330.
Suzhou Sino-US Pharmaceutical Technology Co., Ltd. (China)
A recent entrant in the API market, specializing in fluoroquinolone synthesis with GMP compliance.

2. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource formulation, processing, and packaging to specialized CMOs:

Catalent Pharma Solutions (USA/Europe)
Offers comprehensive formulation, filling, and finishing services, ensuring compliance with regulatory standards.
Patheon (Part of Thermo Fisher Scientific)
Provides end-to-end contract manufacturing, including stability testing and packaging for oral solid dosages like FULVICIN P/G 330.
VHB Life Sciences (India)
Specializes in tablet and capsule manufacturing, with capacity for large volume production and export compliance.
Jubilant Life Sciences (India)
Supplies finished dosage forms and active ingredients, with a focus on quality assurance.

3. Licensed Distributors and Importers

Distribution channels are vital for market penetration:

Medipal Holdings Corporation (Japan)
Distributes through a robust network in Asia and other regions, compliant with local regulatory frameworks.
PMI (Pharmaceutical Manufacturing Inc., USA)
Offers global sourcing and distribution of popular antibiotic formulations, including FULVICIN P/G 330.
Local Regional Distributors
Many countries have authorized distributors who import and supply FULVICIN P/G 330 based on licensing agreements with originators or generic manufacturers.

Regulatory and Certification Considerations

Procuring from suppliers with appropriate certifications ensures regulatory compliance:

Good Manufacturing Practice (GMP) certification from regulatory authorities such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), or respective national agencies.
ISO Certifications (ISO 9001, ISO 13485) for quality management.
Certificate of Analysis (COA)s from suppliers verify API purity, potency, and stability.
GMP-compliant packaging facilities for finished dosage forms.
Suppliers must adhere to local regulatory requirements like the Drug Master File (DMF) submission for APIs or Abbreviated New Drug Applications (ANDA).

Key Procurement Strategies

Supplier Evaluation and Due Diligence

Identifying reliable vendors involves rigorous assessment:

Quality assurance (API purity, stability data).
Regulatory compliance (certifications, audits).
Supply capacity (scalability, lead times).
Pricing and payment terms.
Track record for consistent delivery.

Global sourcing vs. regional partnerships

While global sourcing offers more extensive options, regional suppliers may provide benefits such as faster delivery, localized regulatory compliance, and lower logistics costs.

Future Trends and Market Dynamics

The global demand for fluoroquinolone antibiotics like ciprofloxacin remains steady owing to their efficacy in bacterial infections. The supply chain is increasingly impacted by:

Regulatory tightening—ensuring API compliance with evolving GMP standards.
Manufacturing consolidation—leading to fewer but larger API suppliers.
Geopolitical factors—affecting trade agreements and import/export policies.
Supply chain resilience—necessitating diversification of suppliers.

Emerging players from Southeast Asia, particularly India and China, continue to expand their market share owing to cost advantages and scaling capacity.

Conclusion

Securing reliable suppliers for FULVICIN P/G 330 encompasses sourcing high-quality APIs from reputable manufacturers, partnering with certified CMOs, and ensuring adherence to regulatory standards. Major players like Teva, Hetero Labs, Zhejiang Jiuzhou Pharmaceutical, and CMOs such as Catalent offer robust options. Due diligence remains a cornerstone, focusing on quality assurance, regulatory compliance, and supply capacity, especially amid shifting global market dynamics.

Key Takeaways

API Quality Is Paramount: Prioritize suppliers with GMP certification, verified COAs, and proven manufacturing standards.
Diversify Suppliers: Reduce risk by establishing multiple sourcing channels across trusted regions.
Regulatory Compliance Matters: Ensure all suppliers meet local and international regulatory requirements.
Evaluate Cost vs. Reliability: Competitive pricing should not compromise quality or supply security.
Stay Informed on Market Trends: Monitor geopolitical, regulatory, and technological developments impacting the supply chain.

FAQs

1. Who are the leading global suppliers of ciprofloxacin API for FULVICIN P/G 330?
Major API producers include Teva Pharmaceuticals, Hetero Labs, Zhejiang Jiuzhou Pharmaceutical, and Suzhou Sino-US Pharmaceutical Technology, all adhering to GMP standards and supplying internationally.

2. What certifications should suppliers possess to be considered reliable?
Suppliers should have GMP certification, ISO quality management certifications (ISO 9001, ISO 13485), and verified Certificates of Analysis demonstrating API purity and stability.

3. Are regional suppliers a viable alternative to global API manufacturers?
Yes, regional suppliers can offer benefits like faster delivery, lower logistics costs, and easier regulatory compliance, but they must meet the same rigorous standards for quality and certification.

4. How can companies mitigate risks in sourcing FULVICIN P/G 330?
Diversify supplier base, conduct thorough audits and quality assessments, establish clear contractual quality standards, and maintain strategic inventory levels.

5. What emerging trends influence the supply chain for fluoroquinolone antibiotics?
Regulatory tightening, manufacturing consolidation, geopolitical tensions, and a shift toward regional manufacturing hubs are shaping procurement strategies globally.

References

[1] Global API Market Reports, 2022.
[2] WHO Good Manufacturing Practice Guidelines, 2021.
[3] Company Websites and Regulatory Filings (Teva, Hetero, Zhejiang Jiuzhou).
[4] Market Analysis Publications on Pharmaceutical Supply Chains.

Suppliers and packagers for FULVICIN P/G 330

FULVICIN P/G 330

Suppliers for the Pharmaceutical Drug: FULVICIN P/G 330