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Suppliers and packagers for generic pharmaceutical drug: STREPTOMYCIN SULFATE
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STREPTOMYCIN 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 |
|---|---|---|---|---|---|---|---|---|---|
| Xgen Pharms | STREPTOMYCIN SULFATE | streptomycin sulfate | INJECTABLE;INJECTION | 064210 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-0706-2 | 10 VIAL in 1 BOX (39822-0706-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (39822-0706-1) | 1998-06-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Streptomycin Sulfate
Introduction
Streptomycin sulfate, an aminoglycoside antibiotic discovered in 1943, remains a critical therapeutic agent primarily used to treat tuberculosis and various bacterial infections. Its importance in global health, especially in developing nations battling TB, necessitates robust supply chains. Identifying reliable suppliers for Streptomycin sulfate is essential for healthcare providers, pharmaceutical companies, and governments aiming to ensure consistent access, quality, and affordability.
Global Market Overview
The global demand for Streptomycin sulfate continues to be steady, driven by tuberculosis control programs and treatment of resistant bacterial infections. While newer antibiotics have emerged, Streptomycin's role persists due to its efficacy, affordability, and inclusion in essential medicines lists by the World Health Organization (WHO) [1].
Key factors influencing supplier selection include manufacturing capacity, compliance with Good Manufacturing Practices (GMP), regulatory approvals, and supply chain reliability. The market features a mix of established pharmaceutical giants, generic manufacturers, and specialized biochemical producers.
Major Suppliers of Streptomycin Sulfate
1. Pfizer Inc.
Pfizer historically played a significant role in antibiotic production, including Streptomycin. While the company’s primary focus has shifted away from this niche, Pfizer's legacy manufacturing facilities and licensing agreements with other producers keep its name relevant in sourcing discussions.
2. Sun Pharmaceutical Industries Ltd.
An Indian-based pharmaceutical leader, Sun Pharma manufactures a range of antibiotics, including Streptomycin sulfate. The company adheres to international GMP standards and supplies both domestic and export markets, including WHO prequalification programs.
3. Cipla Limited
Another Indian pharmaceutical giant, Cipla produces Streptomycin sulfate and has a robust supply chain for antibiotics globally. Cipla’s products are commonly used in tuberculosis treatment programs across Africa and Asia, and it has received approval from various health authorities.
4. Sanofi
Sanofi, a global pharmaceutical corporation, supplies Streptomycin sulfate primarily through partnerships and licensing agreements. Its stringent quality assurance protocols ensure high standards, especially in regions where regulatory oversight is rigorous.
5. Local and Regional Manufacturers
Many developing countries host local producers of Streptomycin sulfate, often supplying national health systems directly. Such manufacturers include:
- Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
- Adama Pharmaceuticals (Israel)
- Gland Pharma (India)
These regional suppliers often focus on cost-effective production aligned with local regulatory standards.
Regulatory and Quality Considerations
Reliability depends not only on manufacturing capacity but also on regulatory compliance. Suppliers with WHO prequalification or approval from stringent regulatory authorities (U.S. FDA, EMA, etc.) are preferred choices. The WHO Prequalification Program assesses safety, quality, and efficacy, making prequalified suppliers like Cipla and Sun Pharma trusted sources in low- and middle-income countries.
Additionally, adherence to GMP standards is vital to prevent issues such as contamination or inconsistent potency. Suppliers with robust quality management systems minimize risks associated with substandard or counterfeit medications.
Emerging Trends and Supply Chain Strategies
The COVID-19 pandemic exposed vulnerabilities in pharmaceutical supply chains, prompting an accelerated push toward diversification of suppliers. To mitigate risks, healthcare providers should consider multiple sourcing options, including reputable regional producers, licenced generic manufacturers, and established multinational corporations.
Increasing localization of manufacturing, especially in high TB burden countries, is also a trend. Such strategies reduce dependency on global supply chains and improve access in resource-limited settings.
Partnerships between governments and pharmaceutical companies, as well as incentives for local production, can bolster supply stability for Streptomycin sulfate.
Price Considerations
Price varies based on manufacturing scale, regulatory status, volume, and geographic region. Generic manufacturers in India and China often provide the most cost-effective options, essential for large-scale public health programs. Bulk purchasing agreements, pooled procurement through organizations like the Global Drug Facility (GDF), and negotiations with suppliers enhance affordability.
However, buyers must balance cost with quality assurance, favoring suppliers with transparent quality records and regulatory recognitions over lower-cost, uncertified sources.
Challenges in Supply and Distribution
- Regulatory disparities: Varying standards across countries may impede importation and distribution.
- Manufacturing constraints: Complex synthesis process for streptomycin can limit production scalability.
- Intellectual property issues: Patents and licensing agreements may restrict access in certain regions.
- Supply chain disruptions: Geopolitical instability, logistical issues, and global health emergencies impact availability.
Addressing these challenges requires proactive procurement strategies, regulatory harmonization, and investment in manufacturing capacity.
Conclusion
Ensuring a reliable supply of Streptomycin sulfate requires sourcing from reputable, regulated manufacturers—particularly those with WHO prequalification and GMP compliance. Leading providers like Cipla, Sun Pharma, and regional producers in China and India dominate the market, offering cost-efficient and quality-assured products. Strategic collaborations, diversified sourcing, and regulatory adherence bolster supply chain resilience, vital for ongoing tuberculosis control initiatives and bacterial infection management.
Key Takeaways
- The primary global suppliers include Cipla, Sun Pharma, and regional manufacturers from India, China, and Israel.
- WHO prequalification and GMP compliance are critical in selecting trustworthy sources, especially in resource-limited settings.
- Diversification of supply sources can mitigate risks associated with geopolitical and logistical disruptions.
- Cost savings can be achieved through bulk procurement and engagement with organizations like GDF.
- Strengthening local manufacturing capacities enhances supply security for endemic regions.
FAQs
Q1: Is Streptomycin sulfate available from generic manufacturers?
Yes. Several generic manufacturers, especially in India and China, produce Streptomycin sulfate, adhering to international quality standards, making it accessible worldwide.
Q2: How can I verify the quality of a supplier’s Streptomycin sulfate?
Verify if the supplier is WHO prequalified or approved by relevant regulatory authorities such as the US FDA or EMA. Request batch release certificates, GMP certification, and perform independent testing if necessary.
Q3: Are there alternative antibiotics to Streptomycin sulfate for TB treatment?
Yes. Alternatives include amikacin, kanamycin, and capreomycin. However, Streptomycin remains a vital drug, especially where alternatives are limited.
Q4: What are the main challenges in sourcing Streptomycin sulfate?
Challenges include regulatory disparities, manufacturing constraints, supply chain disruptions, and intellectual property considerations.
Q5: How does WHO support the supply of Streptomycin sulfate?
The WHO facilitates procurement through programs like GDF, prequalifies manufacturers, and provides guidelines to ensure access to quality-assured medicines globally.
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