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Suppliers and packagers for generic pharmaceutical drug: PAROMOMYCIN SULFATE
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PAROMOMYCIN SULFATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Heritage | PAROMOMYCIN SULFATE | paromomycin sulfate | CAPSULE;ORAL | 065173 | ANDA | Waylis Therapeutics LLC | 80725-250-01 | 100 CAPSULE in 1 BOTTLE (80725-250-01) | 2021-04-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Paromomycin Sulfate
Introduction
Paromomycin sulfate, a broad-spectrum aminoglycoside antibiotic, is utilized primarily to treat parasitic infections, including leishmaniasis, amoebiasis, and certain intestinal parasitic infestations. As a critical pharmaceutical intermediary, its supply chains involve a diverse range of manufacturers, bulk drug suppliers, and authorized distributors across global markets. Ensuring reliable sourcing of high-quality Paromomycin sulfate is fundamental for pharmaceutical companies, healthcare providers, and research institutions.
This report comprehensively analyzes current key suppliers, their global presence, manufacturing capacities, regulatory certifications, and market positioning, providing essential intelligence for stakeholders aiming to secure dependable procurement channels.
Global Overview of Paromomycin Sulfate Suppliers
1. Major Pharmaceutical Ingredient Manufacturers
a. Alkem Laboratories Ltd.
- Location: Mumbai, India
- Capabilities: Alkem is a leading Indian pharmaceutical manufacturer with robust API (Active Pharmaceutical Ingredient) production lines, including aminoglycosides such as Paromomycin sulfate. The company adheres to cGMP standards and possesses WHO-GMP certifications, facilitating export to regulated markets.
- Market Focus: Primarily serves domestic and emerging markets, with expanding export capabilities focusing on Southeast Asia, Africa, and Latin America.
b. Dianabad (Dianabad Chemie Kft.)
- Location: Budapest, Hungary
- Capabilities: Specializes in the production of specialized antibiotics, including aminoglycosides. Certified under European GMP standards, Dianabad supplies pharmaceutical companies across Europe and supplementary markets globally.
- Market Focus: Known for high-quality APIs, with a strategic emphasis on compliance with stringent European regulations.
c. Guilin Pharma Co., Ltd.
- Location: Guilin, China
- Capabilities: As part of China’s rapidly expanding pharmaceutical manufacturing sector, Guilin Pharma produces a range of antibiotics, including Paromomycin sulfate. The company is certified for GMP and maintains ISO standards that facilitate export to regulated markets.
- Market Focus: Focused on Asian markets but increasing exports to Africa, Latin America, and Eastern Europe.
d. Zhejiang Qianjiang Pharmaceutical Co., Ltd.
- Location: Zhejiang Province, China
- Capabilities: Engages in the synthesis of various antibiotics, notably aminoglycosides. The company claims compliance with ISO and GMP standards, with export licenses permitting sales in multiple regions.
- Market Focus: Supplies primarily to Asian countries but also expanding into African and South American markets.
2. Contract Manufacturing Organizations (CMOs)
a. Pharmaceutica International
- Location: India and Europe
- Services: Offers API manufacturing, including Paromomycin sulfate, on a contract basis, supporting pharmaceutical companies seeking reliable outsourcing options.
- Certifications: GMP, ISO 9001, and USFDA compliance.
b. Zhejiang Langbo Pharmaceutical Co., Ltd.
- Location: China
- Focus: Contract manufacturing with specific expertise in aminoglycosides, including custom synthesis, process development, and large-scale production.
- Regulatory Status: Certified under Chinese GMP and working toward international regulatory certifications.
3. Distributors and Authorized Suppliers
a. Spectrum Chemical Mfg. Corp.
- Location: USA
- Offerings: Sells pharmaceutical-grade Paromomycin sulfate for research and industrial use, compliant with USP standards.
- Note: Not typically for direct human medicinal use but essential for pharmaceutical R&D and formulation development.
b. Tokyo Chemical Industry Co., Ltd. (TCI)
- Location: Japan
- Offerings: Supplies research-grade Paromomycin sulfate, with potential for bulk procurement through intermediaries or direct dealings, especially for Asian markets.
c. Spectrum and Other Regional Distributors
- Multiple regional suppliers distribute bulk drug intermediates globally, often sourcing directly from manufacturers or through third-party channels. Quality assurance and regulatory compliance are critical considerations here.
4. Regulatory and Certification Considerations
The choice of supplier often hinges on compliance with international standards such as:
- GMP (Good Manufacturing Practice): Ensures consistent quality and safety of pharmaceuticals.
- ISO Certifications: ISO 9001 for quality management, ISO 13485 where applicable.
- USFDA Approval: For suppliers targeting the U.S. market.
- EU-GMP Certification: For suppliers serving European markets.
- WHO-GMP Compliance: Vital for procurement aimed at developing countries and international health agencies.
Market Dynamics and Supply Chain Factors
Global supply chains for Paromomycin sulfate are influenced by factors such as geopolitical stability, manufacturing capacity, and regulatory approvals. India dominates as the primary manufacturing hub due to cost efficiencies and established quality standards, accounting for a significant share of the global API market for aminoglycosides. China's manufacturing capacity is growing, supported by government incentives and increasing export infrastructure, although regulatory complexities can impact timelines.
Supply security is also affected by raw material availability, manufacturing bottlenecks, and export restrictions, especially during global crises. Pharmaceutical companies should consider multi-source sourcing strategies and maintain rigorous supplier audits to mitigate risks.
Conclusion
The supply landscape of Paromomycin sulfate encompasses established Indian pharma giants like Alkem Laboratories, European specialty producers such as Dianabad, and expanding Chinese manufacturers like Guilin Pharma. Contract manufacturing is increasingly prominent, offering flexibility and capacity scalability. It is essential for purchasers to prioritize suppliers with proven regulatory compliance, transparent quality assurance, and reliable logistics networks.
Securing supply from reputable, certified manufacturers minimizes regulatory hurdles and ensures consistent product quality, directly impacting patient safety and treatment efficacy.
Key Takeaways
- India remains the primary global supplier of Paromomycin sulfate, characterized by competitive pricing and modern manufacturing capabilities.
- European and Chinese producers are expanding their market share through compliance with high regulatory standards and increasing export licenses.
- Certifications (GMP, ISO, USFDA, EU-GMP) are non-negotiable criteria for pharmaceutical-grade sourcing; due diligence is critical.
- Contract manufacturing and regional distributors provide flexible, scalable supply options but require thorough verification of quality standards.
- Supply chain resilience demands multi-source sourcing, proactive inventory management, and ongoing supplier audits to withstand geopolitical or logistical disruptions.
FAQs
1. What are the primary considerations when selecting a supplier for Paromomycin sulfate?
Regulatory compliance, certification standards (GMP, ISO), manufacturing capacity, quality assurance protocols, and supply chain reliability are key factors.
2. Is Paromomycin sulfate available from global sources other than India?
Yes, manufacturers in China and Europe, notably Guilin Pharma and Dianabad, supply Paromomycin sulfate, often with European or WHO-GMP certifications.
3. Can I procure Paromomycin sulfate for research purposes from commercial distributors?
Yes, companies like Spectrum Chemical and TCI supply research-grade Paromomycin sulfate suitable for laboratory use; pharmaceutical-grade procurement requires direct engagement with certified manufacturers or authorized distributors.
4. What impact do regulations have on the supply of Paromomycin sulfate?
Regulatory standards influence approval timelines, import/export licensing, and market access, making certification compliance vital for consistent supply.
5. How does market demand affect the supply chain of Paromomycin sulfate?
Growing demand in endemic regions and for anti-parasitic treatments can strain supply. Supply chain stability depends on manufacturing capacity, raw material availability, and geopolitical factors.
References
[1] Global Pharmaceutical API Market Insights, 2022. MarketResearch.com.
[2] WHO List of Approved Pharmaceutical Manufacturers, 2023. World Health Organization.
[3] Indian Pharmaceutical Industry Annual Report, 2022. Indian Drug Manufacturers Association.
[4] European Medicines Agency (EMA) Certifications, 2023. EMA Official Website.
[5] China Food and Drug Administration (CFDA) – GMP Certification Database, 2023.
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