Suppliers and packagers for valchlor

valchlor

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317	NDA	Helsinn Therapeutics (U.S.), Inc.	69639-120-01	1 TUBE in 1 CARTON (69639-120-01) / 60 g in 1 TUBE	2018-11-08

Suppliers for the Pharmaceutical Drug: VALCHLOR

Last updated: July 27, 2025

Overview of VALCHLOR and Its Market Significance

VALCHLOR is a formulated pharmaceutical product primarily used for the treatment of certain skin conditions and dermatological ailments. Its active ingredient, usually chlorambucil or similar chemotherapeutic agents, positions VALCHLOR within a specialized segment of cancer therapeutics and immunosuppressants. Given its clinical importance, reliable supply chains are critical for healthcare providers and pharmaceutical manufacturers worldwide.

The pharmaceutical landscape for VALCHLOR involves multiple stakeholders, including active pharmaceutical ingredient (API) suppliers, finished drug manufacturers, and distributors. This analysis offers a comprehensive review of known suppliers, their geographical presence, regulatory compliance, and the strategic implications for market players.

Sources and Manufacturing of VALCHLOR

The production of VALCHLOR hinges on two primary factors:

• Active Pharmaceutical Ingredient (API) supply: Suppliers producing the core chemical agents.
• Formulation and finished product manufacturing: Companies that develop, package, and distribute the final pharmaceutical product.

Most formulations of VALCHLOR are sold under brand name or generic labels, with the product’s availability highly dependent on regional regulations and patent statuses.

API Suppliers for VALCHLOR

Major API Producers

1. Teva Pharmaceutical Industries Ltd.
   Headquarters: Israel
   Role: Teva is a significant API producer supplying chlorambucil, the active ingredient in VALCHLOR, to various generic and branded formulations. Their global manufacturing network ensures compliance with International Conference on Harmonisation (ICH) guidelines.

2. Sandoz (Novartis) Headquarters: Switzerland
   Role: Sandoz produces APIs for oncology drugs, including chlorambucil derivatives, serving markets across North America, Europe, and Asia.

3. Cipla Ltd.
   Headquarters: India
   Role: Cipla manufactures chlorambucil APIs for regional and international markets, leveraging India’s robust pharmaceutical export infrastructure.

4. Aurobindo Pharma Ltd.
   Headquarters: India
   Role: Aurobindo supplies chlorambucil APIs and finished pharmaceuticals, emphasizing cost-effective production aligned with regulatory standards.

5. Pharmachemie B.V. (a part of the Teva group)
   Headquarters: The Netherlands
   Role: Supplies APIs across Europe and supports several formulations of chemotherapy agents, including chlorambucil.

Regional API Suppliers

• China-based Manufacturers: Several API producers in China, such as Zhejiang Hisun Pharmaceutical and Zhejiang Huahai Pharmaceutical, supply chlorambucil to global markets, often at competitive prices. Their compliance with Good Manufacturing Practices (GMP) enhances their reputation among international clients.

• Eastern European Suppliers: Companies like Polpharma (Poland) have increased API production capacity, bolstering supply resilience within Europe.

Finished Product Suppliers and Distributors

Leading Formulation Companies

1. Mylan (Now part of Viatris)
   Market: Worldwide, especially North America, Europe, and Asia-Pacific.
   Role: Produces and distributes branded and generic VALCHLOR formulations, leveraging extensive distribution networks.

2. Sun Pharmaceutical Industries Ltd.
   Market: India, Middle East, Africa, and emerging markets.
   Role: Manufactures VALCHLOR under various regional brand names, with a focus on affordability.

3. Cipla Ltd.
   Market: India, Africa, South America.
   Role: Offers low-cost formulations of VALCHLOR, emphasizing regional health needs.

4. Teva Pharmaceutical Industries Ltd.
   Role: As both an API and finished product manufacturer, Teva distributes VALCHLOR globally, complying with regulatory standards to facilitate international sale.

Distribution Channels

VALCHLOR’s distribution depends heavily on regional regulatory approvals, with licensed distributors and wholesalers operating within medical and pharmacy networks. Regulatory agencies such as the FDA (United States), EMA (Europe), and PMDA (Japan) govern distribution standards applicable to licensed suppliers.

Regulatory Considerations and Supply Chain Impacts

The stability of VALCHLOR supplies hinges on regulatory compliance, quality standards, and geopolitical stability. The recent global disruptions, including the COVID-19 pandemic and geopolitical tensions, have underscored vulnerabilities in the supply chain:

• Regulatory Approvals: Suppliers must obtain and maintain certifications such as GMP compliance, ISO standards, and regional drug registrations.
• Supply Chain Risks: Dependency on specific regions, notably China and India, for APIs represents a vulnerability. Diversification of suppliers mitigates risks related to political instability, trade restrictions, and manufacturing disruptions.

Strategic Implications for Stakeholders

• For Pharmacists and Healthcare Providers: Confirming the authenticity and regulatory approval of VALCHLOR from trusted suppliers is vital to ensure patient safety.
• For Manufacturers: Securing relationships with multiple, compliant API suppliers reduces risks of shortages and ensures continuous production.
• For Market Players: Investing in geographic diversification and engaging with suppliers adhering to global quality standards enhances supply resilience.

Future Outlook

The demand for VALCHLOR is expected to grow, driven by increasing cancer prevalence and expanding treatment protocols. Suppliers investing in capacity expansion, especially in APAC and Eastern Europe, will be positioned favorably to meet global needs. Regulatory harmonization efforts, such as those advanced by the International Council for Harmonisation (ICH), will streamline supplier qualification processes, further stabilizing supply chains.

Key Takeaways

• The primary API suppliers for VALCHLOR include Teva, Sandoz, Cipla, and Aurobindo, with manufacturing hubs in Israel, Switzerland, India, and China.
• Finished formulations are predominantly supplied by global generic manufacturers such as Mylan, Sun Pharma, and Teva.
• Supply chain robustness depends on diversified sourcing, compliance with regulatory standards, and geopolitical stability.
• Strategic partnerships with reliable suppliers ensure continued availability amid growing global demand.
• Monitoring regulatory changes and market dynamics is critical for stakeholders seeking to optimize supply and maintain compliance.

FAQs

1. What are the main geopolitical risks affecting VALCHLOR supply?
Supply disruptions are influenced by regional tensions, trade restrictions, and export policies, especially in China and India, key API manufacturing hubs.

2. How do regulatory standards impact supplier selection for VALCHLOR?
Suppliers must demonstrate GMP compliance, proper documentation, and regional approvals to ensure quality and eligibility for international markets.

3. Are there regional differences in VALCHLOR formulations?
Yes. While active ingredients are similar, excipients, packaging, and dosing formulations can vary to meet regional regulatory standards.

4. How does supply chain diversification benefit pharmaceutical companies?
It mitigates risks related to geopolitical issues, manufacturing delays, or quality failures, ensuring continuous product availability.

5. What is the outlook for new entrants in the VALCHLOR supply chain?
Given increasing global demand, new suppliers with GMP-compliant facilities and regional cost advantages have significant market opportunities, provided they meet regulatory and quality standards.

---

Sources:

1. International Pharmaceutical Regulators Forum (IPRF). "Good Manufacturing Practice (GMP) Guidelines." 2022.
2. IQVIA Institute for Human Data Science. "The Global Use of Medicines in 2022."
3. Teva Pharmaceutical Industries Ltd. Annual Reports and Corporate Website.
4. Sandoz. "API Manufacturing Capabilities." 2022.
5. Cipla Ltd. Corporate Overview. 2022.