TEPADINA AND SODIUM CHLORIDE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Adienne Sa	TEPADINA AND SODIUM CHLORIDE	thiotepa	POWDER;INTRAVENOUS	208264	NDA	Amneal Pharmaceuticals LLC	70121-1630-1	1 VIAL, GLASS in 1 BOX (70121-1630-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS	2017-08-15
Adienne Sa	TEPADINA AND SODIUM CHLORIDE	thiotepa	POWDER;INTRAVENOUS	208264	NDA	Amneal Pharmaceuticals LLC	70121-1631-1	1 VIAL, GLASS in 1 BOX (70121-1631-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS	2017-08-15
Adienne Sa	TEPADINA AND SODIUM CHLORIDE	thiotepa	POWDER;INTRAVENOUS	208264	NDA	Amneal Pharmaceuticals LLC	70121-2749-1	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX (70121-2749-1)	2025-04-18
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

The pharmaceutical industry relies heavily on a robust supply chain to ensure the availability of essential medications. Among these, TEPADINA (a brand name for melphalan) and sodium chloride have distinct roles—TEPADINA as an alkylating agent used in cancer therapy and sodium chloride as a fundamental compound in medical formulations for reconstitution, injection, and infusion solutions. Ensuring a dependable supplier network for both compounds is vital for healthcare providers, pharmaceutical manufacturers, and regulatory agencies to maintain drug quality, supply stability, and patient safety.

Overview of TEPADINA (Melphalan)

TEPADINA (melphalan) is an alkylating agent predominantly used in chemotherapy protocols against multiple myeloma and ovarian cancer. Its patterned synthesis, high purity requirements, and sensitive handling demand specialized manufacturers with GMP compliance in active pharmaceutical ingredient (API) production.

Major Suppliers of TEPADINA (Melphalan)

Glenmark Pharmaceuticals
- A global pharmaceutical company with active production facilities specializing in anti-cancer agents, including melphalan.
- Their APIs adhere to strict quality standards, approved by multiple regulatory bodies such as the FDA and EMA.
H. Lundbeck A/S
- Known historically for sourcing specific chemotherapeutic API products, including melphalan, from integrated manufacturing processes.
ROTTAPHARM
- A European pharmaceutical API manufacturer supplying melphalan and related compounds with GMP certification.
Amiens-based Pharmaspada
- A less prominent, regional supplier that has established API production lines for alkylating agents, including melphalan, with export capabilities.
Generic API Manufacturers in India and China
- Several Indian companies, such as Jubilant Life Sciences, Hetero Drugs, and Biological E (India), manufacture melphalan API for the global generics market.
- Chinese producers, including Sino Biopharmaceutical and North China Pharmaceutical Group, also serve as sources, with increasing export volumes following regulatory clearances.

Supply Challenges & Considerations

The complexity of manufacturing the API, requiring stringent quality control and specialized synthesis paths.
Licensing agreements and patent statuses influence sourcing, especially in markets where melphalan’s patent has expired or is under patent protection.
Global distribution depends on compliance with USP, EP, and JP standards to meet regulatory expectations.

Sodium Chloride in Pharmaceuticals

Sodium chloride is among the most commonly used inorganic salts in medicine, primarily in saline solutions, reconstitution fluids, and dialysis. Its widespread use coupled with simple synthesis and purification processes has led to an extensive global supplier base.

Key Global Suppliers of Pharmaceutical-Grade Sodium Chloride

BASF SE
- Leading chemical producer offering pharmaceutical-grade sodium chloride with high purity levels suitable for injectable formulations.
Sigma-Aldrich (Merck KGaA)
- Supplies high-grade sodium chloride suitable for pharmaceutical and laboratory applications across worldwide markets.
China National Salt Industry Corporation
- The largest producer in China, with extensive manufacturing capacities for pharmaceutical-grade sodium chloride exported globally.
Tata Chemicals Ltd.
- An Indian multinational offering pharmaceutical-grade sodium chloride, compliant with pharmacopoeia standards and used extensively in injectable and infusion formulations.
Cargill Inc.
- Supplies bulk sodium chloride suitable for medical and industrial pharmaceutical applications with consistent quality management systems.

Supply Dynamics and Regulatory Aspects

The simplicity of synthesis suggests a broad supplier base; ongoing quality assurance is essential to meet pharmacopoeia specifications (USP, EP, BP).
Import/export regulations, especially in the context of contamination control and purity standards, impact sourcing choices.
The global demand for injectable saline solutions sustains a reliable supply chain for pharmaceutical-grade sodium chloride, with surge capacities during health crises such as pandemics.

Market Trends and Supply Chain Considerations

For TEPADINA:
Market dynamics are influenced by patent statuses, with generics dominating supply in many regions. The recent trend involves increasing regulatory scrutiny for APIs, prompting manufacturers to invest in advanced synthesis techniques and manufacturing certification. Regulatory approvals from agencies like the FDA and EMA are crucial for market acceptance, with supply disruptions potentially stemming from geopolitical tensions or manufacturing quality issues.

For Sodium Chloride:
Market stability is high due to the mature, commoditized nature of the compound. However, supply chain resilience is critical, especially amid global disruptions such as COVID-19, which impacted raw material access and transportation logistics. Regulatory compliance and consistent quality standards are paramount for pharmaceutical-grade sodium chloride.

Regulatory and Quality Assurance Factors

Suppliers of both TEPADINA and sodium chloride must adhere to Good Manufacturing Practices (GMP) and gain certification from relevant authorities. For compounds used in injectable formulations, compliance with pharmacopeia standards (USP, EP, BP) ensures safety and efficacy. Due diligence, including audits, ongoing quality testing, and supplier qualification processes, is essential for pharmaceutical companies to mitigate risks associated with contamination, variability, or supply shortages.

Key Takeaways

Diverse Supplier Base: The existence of global suppliers, especially for sodium chloride, offers resilience but mandates rigorous quality vetting.
Regulatory Compliance: Suppliers must meet established pharmacopeia standards and attain GMP certifications to ensure market accessibility.
Manufacturing Complexity: The sensitive synthesis processes of TEPADINA (melphalan) require specialized manufacturers with proven expertise and quality controls.
Market Trends: Generics dominate the melphalan market, with increasing production in India and China, driven by patent expirations and expanding access.
Supply Chain Robustness: Global health emergencies have underscored the importance of diversified sourcing strategies for essential drugs and excipients.

FAQs

1. Who are the leading global suppliers of TEPADINA (melphalan)?
Major suppliers include Glenmark Pharmaceuticals, H. Lundbeck A/S, and regional manufacturers in India and China such as Jubilant Life Sciences and Sino Biopharmaceutical.

2. Is sodium chloride supply secure for pharmaceutical use?
Yes, given its widespread industrial production, with key suppliers such as BASF, Tata Chemicals, and Cargill providing consistent quality, though regulatory compliance remains critical.

3. How do regulatory standards impact supplier selection?
Suppliers must adhere to GMP and pharmacopeia standards (USP, EP, BP). Regulatory approvals influence market access and mitigate compliance risks.

4. What are common challenges faced by suppliers of TEPADINA?
Manufacturing complexity, quality control, patent statuses, and geopolitical factors can impact supply stability.

5. Can regional suppliers meet international quality standards?
Yes, many regional manufacturers in India, China, and Europe have upgraded facilities and certification processes to meet global GMP requirements, ensuring their products' suitability for international markets.

References

[1] U.S. Pharmacopeia. "Melphalan: Monograph," 2021.
[2] European Pharmacopoeia. "Sodium Chloride Monograph," 2022.
[3] GlobalData. "Pharmaceutical API Market Report," 2022.
[4] Industry Reports on Chemotherapeutic APIs, 2021.
[5] WHO. "Pharmaceutical Quality Assurance," 2020.

Suppliers and packagers for TEPADINA AND SODIUM CHLORIDE