Share This Page
Suppliers and packagers for generic pharmaceutical drug: fluphenazine hydrochloride
✉ Email this page to a colleague
fluphenazine hydrochloride
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pharm Assoc | FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | CONCENTRATE;ORAL | 074725 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-0653-04 | 120 mL in 1 BOTTLE, DROPPER (0121-0653-04) | 2010-09-01 |
| Pharm Assoc | FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | ELIXIR;ORAL | 040146 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-0654-02 | 60 mL in 1 BOTTLE (0121-0654-02) | 2010-08-31 |
| Pharm Assoc | FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | ELIXIR;ORAL | 040146 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-0654-16 | 473 mL in 1 BOTTLE (0121-0654-16) | 2010-08-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Fluphenazine Hydrochloride
Introduction
Fluphenazine hydrochloride, a typical antipsychotic medication, is widely prescribed for schizophrenia and psychotic disorders. Its efficacy hinges on consistent pharmaceutical quality, controlled manufacturing processes, and a reliable supplier network. As market dynamics evolve, understanding the landscape of suppliers becomes critical for pharmaceutical companies, healthcare providers, and distributors. This report offers a comprehensive overview of reliable suppliers for Fluphenazine hydrochloride, touching on key factors such as production capabilities, regulatory compliance, geographic distribution, and market presence.
Manufacturers and Suppliers of Fluphenazine Hydrochloride
1. Global Pharmaceutical Raw Material Manufacturers
Several multinational firms and contract manufacturing organizations (CMOs) are recognized as principal suppliers of Fluphenazine hydrochloride, primarily for active pharmaceutical ingredient (API) synthesis and bulk powder procurement.
a. Teva Pharmaceutical Industries Ltd.
A leading global generic drug manufacturer, Teva supplies Fluphenazine hydrochloride API that adheres to strict regulatory standards. Their extensive manufacturing infrastructure in Israel, Hungary, and North America enables high-volume, high-quality production compliant with cGMP (current Good Manufacturing Practices) requirements.
b. Hubei Chusheng Pharmaceutical Co., Ltd.
A prominent Chinese API producer, Hubei Chusheng offers Fluphenazine hydrochloride with competitive pricing and consistent quality, primarily catering to Asian and export markets. The firm's manufacturing facilities are approved by several international regulatory bodies.
c. Zhejiang Hisun Pharmaceutical Co., Ltd.
Another key player headquartered in China, Hisun provides bulk Fluphenazine hydrochloride, with certifications from the NMPA (China's National Medical Products Administration) and international quality standards.
d. Mylan (a Viatris company)
Historically involved in generic APIs, Mylan’s manufacturing divisions have supplied Fluphenazine hydrochloride to global markets, emphasizing supply reliability and regulatory compliance.
2. Contract Manufacturing Organizations (CMOs)
Many pharmaceutical companies collaborate with CMOs to produce Fluphenazine hydrochloride, leveraging specialized expertise and flexible manufacturing capacities. Notable CMOs include:
- Hospira (Pfizer)
- Hetero Labs Ltd. (India)
- Sandoz (Novartis)
They typically produce high-purity API batches tailored to client needs, often under private label agreements.
3. Regional Suppliers and Distributors
Depending on the market, regional suppliers provide smaller quantities or formulations of Fluphenazine hydrochloride, often as finished dosage forms rather than raw API:
- Pharmaceutical distributors in India, South Korea, and Latin America actively source API from primary manufacturers and distribute to local pharmaceutical companies.
- European API suppliers specializing in regulated markets ensure supply chain integrity and compliance.
Criteria for Reliable Suppliers
When evaluating suppliers for Fluphenazine hydrochloride, key considerations include:
- Regulatory Compliance: Suppliers must hold certifications such as cGMP, ISO, and approvals from regulatory agencies (e.g., FDA, EMA, NMPA).
- Quality Consistency: Reliable suppliers demonstrate consistent batch quality and adhere to validated manufacturing processes.
- Supply Capacity: Ability to meet current and projected demand without supply disruptions.
- Traceability and Documentation: Detailed documentation supporting quality, origin, and batch tracking.
- Pricing and Lead Time: Competitive pricing with efficient logistics and delivery mechanisms.
Market Trends and Supply Outlook
The global API market faces ongoing challenges, including supply chain disruptions caused by geopolitical issues, pandemic-related restrictions, and raw material shortages (especially in China and India). Concurrently, regulatory tightening emphasizes quality assurance from suppliers. Consequently, pharmaceutical companies are increasingly diversified in their supplier base to mitigate risks.
Furthermore, regional shifts, such as increased manufacturing in India, are positioning Indian API producers as significant suppliers for Fluphenazine hydrochloride. With Indian authorities enhancing GMP standards and export capabilities, procurement from Indian API manufacturers is forecasted to grow.
Regulatory and Quality Assurance
Suppliers must demonstrate compliance through certification and active engagement with health authorities. For example, suppliers approved by the EMA or FDA are preferred in developed markets due to stringent standards. Suppliers with WHO prequalification status also qualify for procurement by international agencies or programs targeting low-income regions.
Conclusion
The global supply landscape for Fluphenazine hydrochloride features a mature and diversified network of reputable suppliers. Key players include multinational companies like Teva, Chinese API manufacturers such as Hubei Chusheng and Zhejiang Hisun, and collaborating CMOs. Ensuring quality, regulatory compliance, and supply security remains paramount for procurement decisions. As demand persists, especially amid market fluctuations, engagement with suppliers that demonstrate robust quality assurance and supply chain resilience will be crucial.
Key Takeaways
- Diverse Supplier Base: The API industry for Fluphenazine hydrochloride comprises global leaders and regional manufacturers, offering flexibility in sourcing.
- Regulatory Compliance is Crucial: Preference should be given to suppliers with relevant certifications and regulatory approvals to ensure product safety and efficacy.
- Supply Chain Risks: Political, logistical, and raw material challenges impact supply continuity—diversification mitigates risk.
- Regional Shifts: India and China dominate API production, with increasing quality standards and export capacity.
- Strategic Partnerships: Long-term contracts with trusted suppliers and quality assurance agreements improve supply reliability and compliance.
FAQs
1. Who are the top international suppliers of Fluphenazine hydrochloride?
Teva Pharmaceutical Industries and Mylan are among the top global suppliers, known for high-quality API production and broad distribution networks.
2. What are the typical quality certifications to look for in a Fluphenazine hydrochloride supplier?
cGMP compliance, ISO certifications, and approvals from the FDA, EMA, or NMPA indicate regulatory readiness and quality assurance.
3. How does regional manufacturing influence API sourcing?
Regional manufacturing, especially in India and China, offers cost advantages and increased supply flexibility but requires careful verification of regulatory compliance and quality standards.
4. Are there any notable challenges in sourcing Fluphenazine hydrochloride?
Yes, supply disruptions due to geopolitical issues, raw material shortages, and stringent regulatory environments can pose challenges; diversification is essential.
5. What strategies can ensure a reliable supply of Fluphenazine hydrochloride?
Establishing long-term partnerships with multiple approved suppliers, maintaining inventory buffers, and actively monitoring market conditions are key strategies.
References
[1] "Active Pharmaceutical Ingredients (API): Market Overview and Key Players," PharmaIQ, 2022.
[2] "Regulatory Standards for APIs," United States Food and Drug Administration (FDA), 2023.
[3] "Global API Manufacturing Market Report," IQVIA, 2022.
[4] "Chinese API Industry Analysis," China Pharmaceutical Industry Association, 2022.
[5] "Supply Chain Resilience in the Pharmaceutical Industry," McKinsey & Company, 2021.
More… ↓
