Share This Page
Suppliers and packagers for BACTRIM DS
✉ Email this page to a colleague
BACTRIM DS
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Industries | BACTRIM DS | sulfamethoxazole; trimethoprim | TABLET;ORAL | 017377 | NDA | Sun Pharmaceutical Industries, Inc | 49708-145-01 | 100 TABLET in 1 BOTTLE, PLASTIC (49708-145-01) | 2004-11-01 |
| Sun Pharm Industries | BACTRIM DS | sulfamethoxazole; trimethoprim | TABLET;ORAL | 017377 | NDA | Sun Pharmaceutical Industries, Inc | 49708-146-01 | 100 TABLET in 1 BOTTLE, PLASTIC (49708-146-01) | 2004-11-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BACTRIM DS
Introduction
BACTRIM DS, a widely prescribed antimicrobial combination comprising sulfamethoxazole and trimethoprim, remains a cornerstone in the treatment of various bacterial infections such as urinary tract infections, pneumocystis pneumonia, and shigellosis. Its manufacturing and supply chain involve an intricate network of pharmaceutical companies, contract manufacturers, and distribution channels worldwide. This article provides a comprehensive analysis of the key suppliers for BACTRIM DS, emphasizing market dynamics, manufacturing sources, and distribution platforms. The goal is to assist healthcare providers, investors, and industry stakeholders in understanding the current landscape of BACTRIM DS supply.
Overview of BACTRIM DS
BACTRIM DS signifies the double strength formulation, typically containing sulfamethoxazole (800 mg) and trimethoprim (160 mg) per tablet. Since its approval, BACTRIM DS has been produced by multiple pharmaceutical manufacturers globally, often under brand-name and generic labels. The product's complex formulation mandates strict compliance with Good Manufacturing Practices (GMP), quality control, and supply chain management, making supplier selection crucial for ensuring drug availability and regulatory compliance.
Key Manufacturers and Suppliers
1. Original Brand Manufacturers
The original developer of BACTRIM DS was Glenmark Pharmaceuticals, marketed initially as Septra DS in some regions. Over time, its manufacturing rights transitioned across several companies due to mergers, acquisitions, and licensing agreements. Currently, Pfizer holds a significant market share in the production and distribution of BACTRIM DS under various licensing arrangements, especially in the United States.
2. Leading Generic Manufacturers
The generic drug market for BACTRIM DS is highly competitive. Numerous pharmaceutical companies globally manufacture and supply sulfamethoxazole and trimethoprim formulations:
-
Mylan (now part of Viatris): As one of the largest generic providers worldwide, Viatris supplies BACTRIM DS through extensive manufacturing facilities with established distribution channels.
-
Teva Pharmaceutical Industries: A major global generic producer, Teva manufactures BACTRIM DS formulations in various markets, emphasizing cost-effective production and broad distribution.
-
Sandoz (a Novartis division): Sandoz supplies high-quality generic BACTRIM DS formulations, often focusing on European and emerging markets.
-
Wockhardt: Known for manufacturing high-quality antibiotics, Wockhardt supplies BACTRIM DS in several Asian markets.
-
Dr. Reddy’s Laboratories: Active in multiple geographies, Dr. Reddy’s provides BACTRIM DS through its extensive global manufacturing network.
3. Contract Manufacturing and Licensing
Contract manufacturing organizations (CMOs) play a vital role in the supply chain for BACTRIM DS. These organizations, often located in India, China, and Eastern Europe, produce formulations under licensing agreements for licensed manufacturers. Examples include:
-
Hetero Drugs: An Indian-based CMO known for large-scale antibiotic production, including sulfamethoxazole and trimethoprim combinations.
-
Aurobindo Pharma: Supplies generic BACTRIM DS formulations, leveraging its extensive manufacturing capabilities.
-
Cadila Healthcare: Also involved in the production of antibiotics, with formulations supplied globally.
4. Raw Material Suppliers
The production of BACTRIM DS hinges on high-quality active pharmaceutical ingredients (APIs):
-
Sulfamethoxazole APIs are sourced from a variety of chemical manufacturers with facilities in India, China, and Europe.
-
Trimethoprim APIs similarly originate from reputable API producers across Asia and Europe.
Key API suppliers include Hetero Labs, Alkem Laboratories, and Shenzhen Yaxin (China), which supply APIs conforming to pharmaceutical standards such as USP and EP.
Supply Chain Dynamics
Global Manufacturing Network
The manufacturing network of BACTRIM DS relies heavily on Asia, particularly India and China, owing to cost efficiencies and established pharmaceutical infrastructure. Indian companies like Sun Pharma, Aurobindo, and Cipla serve as significant suppliers of both APIs and finished formulations.
Quality and Regulatory Compliance
Maintaining consistent quality is paramount due to the drug’s use in serious infections. GMP compliance, stability testing, and batch certification are crucial at every manufacturing stage. Regulatory agencies such as the FDA and EMA periodically audit manufacturing facilities to ensure standards are upheld.
Distribution Channels
Post-production, BACTRIM DS formulations are distributed through wholesalers, hospital pharmacies, and retail outlets worldwide. Major pharmaceutical distributors like McKesson, AmerisourceBergen, and Cardinal Health facilitate the extensive reach necessary for timely patient access.
Market Trends and Supply Security
The global demand for BACTRIM DS remains steady owing to its efficacy and versatility. However, supply disruptions can occur due to raw material shortages, political risks, or manufacturing issues. Companies actively diversify API sources and maintain multiple manufacturing sites to mitigate risks.
Emerging Industry Trends
1. Increasing Generic Competition
The proliferation of generic manufacturers has driven prices down, enhancing access but potentially impacting supplier margins. Suppliers invest in manufacturing efficiency and quality to retain market share.
2. Consolidation in the Pharmaceutical Supply Chain
Major industry consolidation, such as Viatris acquiring Mylan or Teva's restructuring, affects supply dynamics by reducing the number of suppliers and increasing reliance on key manufacturers.
3. Geopolitical and Supply Chain Resilience
Pandemic-related disruptions underscored the importance of supply chain resilience. Industry leaders are now diversifying raw material sources and expanding manufacturing footprints to ensure stability.
4. Regulatory and Quality Integrity
Stringent global regulatory standards compel suppliers to uphold impeccable quality and traceability standards, fostering higher confidence among healthcare providers and regulators.
Regulatory Considerations
Regulatory approval for BACTRIM DS formulations requires rigorous validation of manufacturing processes, quality control, and stability data. Suppliers must maintain consistent documentation and batch records for audits. Variations in APIs or excipient suppliers may trigger regulatory reviews under GMP standards.
Conclusion
The supply landscape for BACTRIM DS is characterized by a diverse network of global manufacturers, contract organizations, and raw material suppliers. Leading pharmaceutical companies, predominantly based in India, China, and Europe, supply both APIs and finished formulations, adhering to strict quality standards. Industry consolidation, regulatory challenges, and supply chain resilience remain top priorities for stakeholders. Ensuring robust supplier relationships and diversified supply sources are critical for maintaining the continuous availability of this essential antimicrobial agent.
Key Takeaways
-
Major suppliers of BACTRIM DS include industry leaders such as Viatris, Teva, Sandoz, and Indian manufacturers like Aurobindo and Sun Pharma.
-
The supply chain depends heavily on API producers from India and China, emphasizing the need for continuous quality assurance.
-
Contract manufacturing organizations facilitate large-scale production, allowing for flexible responses to market demand fluctuations.
-
Global supply resilience strategies now prioritize diversification of raw materials, geographic distribution, and regulatory compliance.
-
Stakeholders should monitor industry consolidations and geopolitical developments that may impact BACTRIM DS availability.
FAQs
1. Who are the leading manufacturers of BACTRIM DS globally?
Major players include Viatris (formerly Mylan), Teva Pharmaceutical Industries, Sandoz (Novartis), and Indian companies like Aurobindo and Sun Pharma.
2. What are the primary raw materials sourcing concerns for BACTRIM DS?
The key APIs—sulfamethoxazole and trimethoprim—are predominantly sourced from India and China, with concerns centered on supply stability and quality assurance.
3. How does regulation impact suppliers of BACTRIM DS?
Regulatory agencies enforce GMP standards, requiring suppliers to maintain rigorous quality controls, documentation, and stability testing, impacting manufacturing practices and licensing.
4. Are there regional differences in BACTRIM DS supply?
Yes. While developed markets often rely on branded and high-quality generic suppliers, emerging markets benefit from regional generic manufacturers, with potential variations in API sourcing and formulation standards.
5. What are global supply chain risks for BACTRIM DS?
Risks include raw material shortages, geopolitical tensions, factory closures, and disruptions caused by health crises like the COVID-19 pandemic. Diversification and strategic inventory management are vital mitigation approaches.
Sources
[1] U.S. Food and Drug Administration (FDA). "Approved Drug Products with Therapeutic Equivalence Evaluations," 2023.
[2] IQVIA. "Global Pharmaceutical Market Data," 2023.
[3] Pfizer. "Company Portfolio and Licensing Agreements," 2023.
[4] Indian Pharmacopoeia Commission. "API Standardization and Quality Reports," 2022.
[5] Industry reports on global API manufacturing and supply chain resilience, 2022.
More… ↓
