Share This Page
Suppliers and packagers for BICILLIN C-R
✉ Email this page to a colleague
BICILLIN C-R
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| King Pharms Llc | BICILLIN C-R | penicillin g benzathine; penicillin g procaine | INJECTABLE;INJECTION | 050138 | NDA | Pfizer Laboratories Div Pfizer Inc | 60793-600-10 | 10 SYRINGE in 1 PACKAGE (60793-600-10) / 2 mL in 1 SYRINGE (60793-600-02) | 1953-05-18 |
| King Pharms Llc | BICILLIN C-R | penicillin g benzathine; penicillin g procaine | INJECTABLE;INJECTION | 050138 | NDA | Pfizer Laboratories Div Pfizer Inc | 60793-601-10 | 10 SYRINGE in 1 PACKAGE (60793-601-10) / 2 mL in 1 SYRINGE (60793-601-02) | 1953-05-18 |
| King Pharms Llc | BICILLIN C-R | penicillin g benzathine; penicillin g procaine | INJECTABLE;INJECTION | 050138 | NDA | Pfizer Laboratories Div Pfizer Inc | 60793-602-10 | 10 SYRINGE in 1 PACKAGE (60793-602-10) / 2 mL in 1 SYRINGE (60793-602-02) | 1953-05-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BICILLIN C-R
Introduction
BICILLIN C-R, a long-acting penicillin antibiotic formulated by combining penicillin G procaine with penicillin V benzathine, remains a critical line of defense against bacterial infections such as syphilis and certain streptococcal infections. Despite its age, BICILLIN C-R continues to be widely utilized globally, emphasizing the importance of understanding its supply landscape. Accurate identification of suppliers not only aids pharmaceutical procurement strategies but also ensures drug quality and regulatory compliance. This article provides a comprehensive overview of key suppliers for BICILLIN C-R, examining manufacturer profiles, geographic distribution, and market trends.
Manufacturers and Global Suppliers of BICILLIN C-R
1. Pfizer Inc.
Pfizer, headquartered in the United States, historically produced BICILLIN C-R as part of its broader portfolio of penicillin-based therapies. As an industry leader with extensive manufacturing capabilities, Pfizer's supply chain for BICILLIN C-R often influences global availability. However, in recent years, Pfizer has scaled back production of certain older antibiotics to prioritize newer therapies, leading to limited availability in some regions (Pfizer's official site; industry reports).
2. Sanofi-Aventis
Sanofi, a French multinational, has historically manufactured various forms of penicillin derivatives, including BICILLIN C-R. Known for its global reach, Sanofi's involvement ensures widespread distribution, particularly in European and emerging markets. Trials and regulatory renewals have kept Sanofi as a significant supplier of BICILLIN C-R within regional markets.
3. Teva Pharmaceuticals
Based in Israel, Teva has expanded its portfolio to include generic antibiotics, and it is a notable producer of penicillin formulations, including BICILLIN C-R. Teva's manufacturing centers in Israel and Eastern Europe supply multiple markets, often at lower price points, making it a vital supplier in regions with cost-sensitive healthcare systems.
4. Lek Pharmaceuticals (a Sandoz division)
Part of Novartis, Lek Pharmaceuticals supplies penicillin derivatives through its Sandoz division. While primarily focused on generics, Sandoz's extensive manufacturing network allows for the production of BICILLIN C-R to meet regional demands, particularly in Central and Eastern Europe.
5. Local and Regional Manufacturers
In addition to the major multinational corporations, several regional manufacturers produce BICILLIN C-R under licensing agreements or through generic formulations. These include companies in India, China, and Latin America:
- Cadila Healthcare (India): Offers generic penicillin formulations suitable for regional distribution.
- Hoffmann-La Roche (Switzerland): Historically engaged in penicillin production, although its current focus is more on diagnostics.
- Incepta Pharmaceuticals (Bangladesh): Produces various penicillin derivatives, including BICILLIN C-R, primarily for South Asian markets.
Regulatory and Quality Considerations
It is imperative for healthcare providers and procurement agencies to verify manufacturer credentials and regulatory approvals. WHO prequalification status, FDA approval, and EMA licensing are critical indicators of reliability. Counterfeit and substandard products pose significant health risks, especially with injectable antibiotics like BICILLIN C-R.
Supply Chain Dynamics and Market Trends
Global Demand and Supply Fluctuations
The demand for BICILLIN C-R remains steady due to its efficacy and cost-effectiveness. Nonetheless, supply chain disruptions—stemming from manufacturing facility closures, geopolitical issues, or regulatory hurdles—can impact availability. The COVID-19 pandemic highlighted vulnerabilities in global pharmaceutical supply chains, affecting the procurement of antibiotics like BICILLIN C-R [1].
Generic vs. Branded Suppliers
While branded formulations from Pfizer and Sanofi dominate certain markets, generics produced by companies like Teva and regional manufacturers have surged, especially in low- and middle-income countries (LMICs). The availability of cost-effective generics has increased access but raises concerns regarding standardization and quality control.
Regulatory Approvals and Market Access
Regulatory pathways influence supplier proliferation. Regional registration and approval processes can either facilitate or hinder market entry for new suppliers. Companies that have obtained WHO prequalification or stringent regulatory authority (SRA) approvals are better positioned to supply reliably.
Emerging Markets and Local Production
Many LMICs have developed local manufacturing capacity, reducing dependency on imports. Governments and international organizations often encourage local production of essential medicines, including BICILLIN C-R, to improve access and stability.
Key Suppliers Summary
| Supplier | Region | Products | Regulatory Status | Notes |
|---|---|---|---|---|
| Pfizer | Global | BICILLIN C-R (discontinued/regional availability) | FDA, EMA, WHO PQ | Historically primary provider; limited current production |
| Sanofi | Europe, Africa | BICILLIN C-R | EMA, WHO PQ | Strong regional presence in Europe and Africa |
| Teva Pharmaceuticals | Middle East, Europe, Asia | Generic penicillin formulations | FDA, EMA, local approvals | Cost-effective options, large manufacturing capacity |
| Sandoz (Novartis) | Europe, Asia | Generics | EMA, USFDA | Regional availability |
| Local Manufacturers | Asia, Latin America | BICILLIN C-R | Varies | Essential for supply in LMICs |
Conclusion
The supply landscape for BICILLIN C-R is characterized by a combination of multinational companies and regional manufacturers, with geographic factors influencing availability. While major players such as Sanofi and Teva maintain significant roles, regional producers fill critical gaps, especially in LMICs. Industry stakeholders should prioritize manufacturers with proven regulatory approval and supply chain resilience to ensure consistent access to this vital antibiotic.
Key Takeaways
- Diverse Manufacturer Base: Multiple suppliers, including Pfizer, Sanofi, Teva, and regional manufacturers, ensure broader access but require due diligence regarding quality and regulatory approvals.
- Regional Production as a Supply Stabilizer: Local manufacturing in LMICs enhances supply stability and decreases dependency on imports.
- Regulatory Validation Is Critical: Only procure BICILLIN C-R from suppliers validated by recognized agencies (WHO PQ, FDA, EMA) to mitigate safety risks.
- Supply Chain Vulnerability: Disruptions due to geopolitical or operational issues can impact availability; diversification of suppliers reduces risks.
- Emerging Trends: Growth in generic production, coupled with the demand for cost-effective antibiotics, continues to shape the supply landscape.
FAQs
1. Is BICILLIN C-R still widely available worldwide?
Availability varies regionally. While it remains a critical antibiotic in many countries, some multinational manufacturers have scaled back production, relying more on regional suppliers or generics to meet demand.
2. What should be considered when selecting a supplier for BICILLIN C-R?
Regulatory approval status, manufacturing quality standards, supply chain reliability, compliance with Good Manufacturing Practices (GMP), and regional regulatory approvals are key considerations.
3. Are generic versions of BICILLIN C-R reliable?
Generics from reputable manufacturers that have obtained WHO prequalification or approval from stringent regulatory authorities are generally reliable. Caution should be exercised with unverified sources.
4. How do geopolitical factors impact BICILLIN C-R supply?
Trade restrictions, sanctions, and regional conflicts can disrupt manufacturing and distribution channels, emphasizing the importance of diversified sourcing strategies.
5. How has COVID-19 affected the supply of BICILLIN C-R?
Global pandemic-related disruptions impacted manufacturing facilities and logistics, leading to shortages in some markets. The industry is increasingly prioritizing supply chain resilience for essential medicines like BICILLIN C-R.
References
[1] World Health Organization. (2021). Supply chain disruptions during COVID-19: Impacts on antibiotics. WHO Reports.
More… ↓
