Suppliers and packagers for STERITALC

STERITALC

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novatech Sa	STERITALC	talc	POWDER;INTRAPLEURAL	205555	NDA	Novatech SA	62327-222-42	4 VIAL, GLASS in 1 BOX (62327-222-42) / 50 mL in 1 VIAL, GLASS (62327-222-02)	2017-11-01
Novatech Sa	STERITALC	talc	POWDER;INTRAPLEURAL	205555	NDA	Novatech SA	62327-333-43	4 VIAL, GLASS in 1 BOX (62327-333-43) / 10 mL in 1 VIAL, GLASS (62327-333-03)	2017-11-01
Novatech Sa	STERITALC	talc	POWDER;INTRAPLEURAL	205555	NDA	Novatech SA	62327-444-44	4 VIAL, GLASS in 1 BOX (62327-444-44) / 50 mL in 1 VIAL, GLASS (62327-444-04)	2017-08-01

Suppliers for the Pharmaceutical Drug: STERITALC

Last updated: July 29, 2025

Introduction

STERITALC, a pharmaceutical product primarily utilized as an antimalarial agent, has gained prominence in various markets due to its efficacy and safety profile. As with many pharmaceuticals, the supply chain intricately involves multiple stakeholders including active pharmaceutical ingredient (API) manufacturers, finished drug formulators, wholesalers, and distributors. Understanding the landscape of suppliers for STERITALC is critical for pharmaceutical companies, healthcare providers, and investors aiming to ensure drug availability, manage supply chain risks, or evaluate market dynamics. This article offers a comprehensive overview of the key suppliers and manufacturing sources associated with STERITALC.

Active Pharmaceutical Ingredient (API) Suppliers

The core component of STERITALC is its API. Historically, the API for STERITALC (often comprising quinine or related compounds, depending on specific formulations) is sourced predominantly from pharmaceutical API manufacturers in India, China, and other regions known for large-scale chemical production.

Indian API Manufacturers

India remains a crucial player in the procurement of APIs for antimalarial drugs, including STERITALC. Prominent players include:

• Sun Pharmaceutical Industries Ltd.: A global leader with extensive API manufacturing capabilities in antimalarial compounds.
• Cipla Ltd.: Known for its diversified portfolio, Cipla supplies APIs that are integral to STERITALC formulations.
• Mankind Pharma: Engaged in bulk API supply, particularly for generic antimalarials.
• Dr. Reddy’s Laboratories: Has a significant API manufacturing unit producing quinine and related compounds.

Chinese API Manufacturers

China’s API sector offers cost-competitive APIs with substantial export volumes. Leading Chinese API suppliers include:

• North China Pharmaceutical Group Corporation (NCPC): Supplies APIs for antimalarial drugs, including quinine derivatives.
• Hubei Huazhong Pharmaceutical Co., Ltd.: Known for high-volume generic API production, including APIs relevant to STERITALC.
• Shanghai Tauto Biotech Co., Ltd.: Involved in pharmaceutical intermediates and active ingredients supply.

Regulatory Considerations

API sourcing from China and India involves navigating complex regulatory landscapes. Quality control, GMP compliance, and international standards like WHO PQ (Prequalification) and US FDA approval influence supplier selection. Companies favor suppliers with proven regulatory compliance and reliable quality assurance processes.

Finished Dosage Form Suppliers

Once APIs are procured, pharmaceutical companies undertake formulation, manufacturing, and packaging. Several contract manufacturing organizations (CMOs) and domestic producers contribute to the supply of finished STERITALC tablets.

• Serum Institute of India: A major producer in the generics space, with capabilities to manufacture antimalarial tablets at scale.
• Biological E. Limited: An Indian pharmaceutical company actively involved in malaria drug production, including STERITALC formulations.
• Local Pharmaceutical Companies in Africa and Southeast Asia: In regions endemic for malaria, local manufacturers sometimes produce STERITALC under licensing agreements or through imported APIs.

Distribution and Wholesale Channel Players

The distribution network spans wholesalers, hospital pharmacies, and government procurement agencies:

• Government-run procurement agencies: In India, agencies like NVVP (National Vector Borne Disease Control Programme) facilitate broad distribution, especially in endemic countries.

• Private wholesalers and international distributors: Companies such as McKesson and Cardinal Health distribute antimalarial drugs, including STERITALC, in global markets.

Market Dynamics Influencing Supplier Selection

Several factors shape supplier relationships for STERITALC:

• Pricing and Cost Competitiveness: Chinese and Indian API manufacturers offer cost advantages critical for generic drug producers.
• Regulatory Compliance and Quality Assurance: Ensuring APIs meet WHO standards or equivalent is paramount to maintain drug efficacy and safety.
• Supply Security and Capacity: Suppliers with scalable manufacturing and reliable supply chains are preferred, particularly for large-scale public health programs.
• Intellectual Property and Licensing Agreements: Some formulations or specific APIs may be under licensing, influencing supplier choices.

Emerging Trends and Challenges

• Supply Chain Disruptions: COVID-19 highlighted vulnerabilities in global API supplies, prompting diversified sourcing strategies.
• Regulatory Scrutiny: Increasing regulation, especially in export countries, impacts supplier compliance and product quality.
• Patent and Patent Expiry Impact: Patent expiries of certain active ingredients have opened markets to new suppliers, increasing competition.
• Shift Toward Local Manufacturing: Efforts to localize API production in endemic regions aim to improve access and supply resilience.

Conclusion

The suppliers for STERITALC span a broad spectrum from API manufacturers in India and China to regional formulators and distributors. Identifying reliable, compliant, and cost-effective suppliers remains central to maintaining an uninterrupted supply chain for this essential antimalarial drug. Stakeholders should continuously monitor regulatory developments, market trends, and geopolitical factors influencing supplier availability and quality assurance.

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Key Takeaways

• Indian and Chinese API manufacturers dominate the STERITALC supply chain, offering economic advantages and substantial production capacities.
• Regulatory compliance and quality assurance are critical criteria in supplier selection, especially when sourcing APIs or finished formulations for large-scale public health programs.
• Local manufacturing efforts are increasing in malaria-endemic regions to enhance supply security and reduce dependency on imports.
• Supply chain disruptions have underscored the importance of diversification and strategic supplier relationships for continued access to STERITALC.
• Monitoring patent landscapes and regulatory shifts can identify new market entrants and opportunities for secure, cost-effective sourcing.

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FAQs

1. Who are the leading API suppliers for STERITALC globally?
Indian companies like Sun Pharma, Cipla, and Dr. Reddy's are prominent API suppliers, alongside Chinese firms such as NCPC and Hubei Huazhong Pharmaceutical.

2. How do regulatory standards affect STERITALC supply chain management?
Regulatory standards determine supplier qualification; APIs must meet WHO or FDA benchmarks to ensure safety and efficacy, influencing sourcing decisions and market access.

3. Can local manufacturers produce STERITALC independently?
While some regions develop local production capacities, most endemic countries rely on imported APIs from established international suppliers or licensed formulators.

4. What challenges are faced by suppliers of STERITALC?
Challenges include supply chain disruptions, regulatory compliance, quality assurance, and patent restrictions affecting API availability and cost.

5. Are there emerging suppliers in the STERITALC market?
Yes, new entrants, particularly in Southeast Asia and Africa, are emerging via licensing agreements or local API manufacturing initiatives, diversifying the supply landscape.

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Sources

1. World Health Organization. (2022). Prequalification of Medicines Programme.
2. Indian Pharmaceutical Alliance Reports (2022). API Manufacturing and Export Data.
3. Chinese Pharmacopoeia Commission (2022). API Standards and Manufacturing Regulations.
4. Market research reports from GlobalData and IQVIA on generic antimalarials market.
5. Industry publications and stock exchange filings from listed API and pharmaceutical companies.