Suppliers and packagers for TEPADINA

TEPADINA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Adienne Sa	TEPADINA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	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	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	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	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	208264	NDA	Amneal Pharmaceuticals LLC	70121-1687-1	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX (70121-1687-1)	2025-04-18

TEPADINA Supply Chain Analysis

Last updated: February 19, 2026

TEPADINA (Temozolomide) is an alkylating agent used in the treatment of certain brain tumors, primarily glioblastoma multiforme. Its active pharmaceutical ingredient (API), temozolomide, requires specialized synthesis and strict quality control. Understanding the supply chain for TEPADINA involves identifying key API manufacturers, formulation sites, and regulatory considerations impacting global supply.

Who are the primary manufacturers of Temozolomide API?

The production of temozolomide API is concentrated among a limited number of specialized chemical manufacturers. These companies possess the necessary expertise in complex organic synthesis and adherence to Good Manufacturing Practices (GMP) required for pharmaceutical-grade APIs.

• Key API Manufacturers:
  • Teva Pharmaceutical Industries Ltd. is a significant global producer of generic pharmaceuticals and APIs. Teva manufactures temozolomide API at its facilities, serving both its own finished dosage forms and potentially other pharmaceutical companies.
  • Intas Pharmaceuticals Ltd., through its API division, Intas Pharma, is another notable supplier of temozolomide API. Intas has a broad portfolio of APIs and has been identified as a supplier for various markets.
  • Sun Pharmaceutical Industries Ltd. is a major Indian multinational pharmaceutical company that also produces temozolomide API. Sun Pharma's API division is robust and supplies numerous markets globally.
  • Aarti Drugs Ltd. is an Indian API manufacturer that has been involved in the production of temozolomide API. The company focuses on developing and manufacturing complex APIs.
  • Cadila Healthcare Ltd. (Zydus Lifesciences) has also been involved in the production or supply of temozolomide API, contributing to the global availability of this critical drug substance.

These manufacturers are typically audited by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to ensure compliance with stringent quality and safety standards.

What are the regulatory requirements for Temozolomide API and finished TEPADINA product?

The regulatory landscape for TEPADINA and its API is governed by international pharmaceutical regulations. Compliance is mandatory for market authorization and continuous supply.

• API Regulatory Standards:

  • Good Manufacturing Practices (GMP): Manufacturers must adhere to cGMP standards as defined by regulatory bodies like the FDA (21 CFR Parts 210 and 211) and EMA. This covers all aspects of production, including facility design, equipment, personnel, raw material control, process validation, and quality control testing.
  • Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. A DMF contains confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. This allows regulatory agencies to review the API's quality without disclosing proprietary information to the finished drug product manufacturer.
  • Impurity Profiling: Strict control over impurities, including process-related impurities and degradation products, is critical. Analytical methods must be validated to detect and quantify these impurities at specified limits.
  • Stability Studies: API must demonstrate stability under defined storage conditions to ensure its quality throughout its shelf life.

• Finished Product Regulatory Standards:

  • Marketing Authorization Application (MAA) / New Drug Application (NDA): Companies seeking to market TEPADINA must submit comprehensive dossiers to regulatory authorities. These include data on the API's quality, manufacturing process for the finished dosage form, analytical methods, stability data, non-clinical studies, and clinical trial results demonstrating safety and efficacy.
  • ICH Guidelines: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines provide harmonized standards for quality, safety, efficacy, and multidisciplinary aspects. Relevant guidelines include Q7 (GMP for APIs), Q1 (Stability), Q2 (Analytical Validation), and Q3 (Impurities).
  • Pharmacopeial Standards: The finished product and API must meet specifications outlined in official pharmacopeias, such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP).
  • Post-Marketing Surveillance: Ongoing monitoring of the drug's safety and effectiveness in the market is required, including reporting of adverse events.

Which companies are involved in the formulation and marketing of TEPADINA?

The formulation and marketing of TEPADINA are primarily handled by pharmaceutical companies that hold the marketing authorization for the branded or generic product.

• Branded Product Manufacturer:

  • Temodar® (TEPADINA): The originator product, Temodar®, was developed and is marketed by Merck & Co., Inc. (known as MSD outside the United States and Canada). Merck manufactures or contracts the manufacturing of the finished dosage form, which includes the temozolomide API formulated into capsules.

• Generic Product Manufacturers: Following patent expiries, several generic pharmaceutical companies have entered the market, offering temozolomide capsules. These companies source temozolomide API from the manufacturers listed previously and formulate it into their own generic versions. Examples of companies that have marketed or are marketing generic temozolomide include:

  • Teva Pharmaceutical Industries Ltd. (as noted for API production, Teva also markets finished generic products).
  • Sun Pharmaceutical Industries Ltd.
  • Dr. Reddy's Laboratories Ltd.
  • Mylan N.V. (now part of Viatris Inc.)
  • Accord Healthcare Ltd.
  • Hetero Drugs Ltd.

The selection of formulation sites is critical, requiring validated processes and adherence to GMP for the finished product. These sites must be approved by regulatory agencies in the regions where the product is marketed.

What are the key challenges in the TEPADINA supply chain?

The TEPADINA supply chain, like many specialized pharmaceutical products, faces several challenges that can impact availability and cost.

• API Sourcing and Quality Control:

  • Limited Supplier Base: The number of approved and capable temozolomide API manufacturers is not as extensive as for more common APIs. This concentration can lead to supply disruptions if a key manufacturer encounters production issues.
  • Stringent Quality Requirements: Ensuring consistent API quality that meets global regulatory standards requires robust quality management systems and rigorous testing. Any deviation can lead to batch rejection and delays.
  • Price Volatility: Dependence on a few API suppliers can make pricing subject to market dynamics and potential cost increases.

• Manufacturing and Formulation Complexity:

  • Specialized Synthesis: The synthesis of temozolomide is a multi-step chemical process that requires specific expertise and equipment.
  • Stability of the API and Drug Product: Temozolomide is sensitive to moisture and heat, requiring careful handling, storage, and packaging to maintain its integrity throughout the supply chain. The finished dosage form must also be formulated to ensure stability.
  • GMP Compliance: Maintaining consistent GMP compliance across all manufacturing and formulation sites is an ongoing operational challenge, involving regular audits and process validation.

• Regulatory and Market Access Hurdles:

  • Global Regulatory Variations: Different countries have distinct regulatory approval processes, requiring tailored submissions and potentially lengthy review times, impacting the speed of market entry and expansion.
  • Intellectual Property (IP) Landscape: While the primary patents for the originator product may have expired, managing the IP landscape, including potential process patents or formulation patents, can be complex for generic manufacturers.
  • Competition from Generics: While beneficial for patient access and cost, the proliferation of generic versions can lead to intense price competition among manufacturers.

• Logistics and Distribution:

  • Temperature and Humidity Control: Maintaining controlled temperature and humidity throughout the distribution network is essential to prevent degradation of the API and finished product.
  • Supply Chain Transparency: Ensuring full traceability of the product from API source to patient is crucial for quality assurance and to combat counterfeiting.

What is the typical lead time for TEPADINA API production and finished product manufacturing?

Lead times for pharmaceutical manufacturing can vary significantly based on production scale, existing inventory, and the complexity of the process.

• API Production Lead Time:

  • The production of temozolomide API typically involves multi-step chemical synthesis. From raw material sourcing to final purification and quality release, the lead time can range from 3 to 6 months. This period includes process optimization, scale-up, validation batches, and thorough quality control testing.
  • For established products with ongoing demand, manufacturers may maintain a buffer stock of API to mitigate short-term supply fluctuations. However, significant increases in demand can extend these lead times.

• Finished Product Manufacturing Lead Time:

  • The manufacturing of the finished TEPADINA dosage form (capsules) generally involves a shorter lead time once the API is available. This can range from 2 to 4 months for a specific batch, including formulation, encapsulation, quality testing, and packaging.
  • This period also accounts for batch record review, stability testing of the finished product batches, and preparation for release to the market.
  • The overall lead time from ordering API to having finished product ready for distribution can therefore be 5 to 10 months, depending on the specific manufacturing schedule and API availability.

• Factors Influencing Lead Times:

  • Raw Material Availability: The availability of upstream chemical precursors for temozolomide synthesis can impact API production timelines.
  • Production Capacity: The available manufacturing capacity at both API and finished product sites is a critical factor. Ramping up production for unexpected demand can take time.
  • Regulatory Approvals: For new generic products or manufacturing site changes, obtaining regulatory approvals can add significant time to the overall supply chain setup.
  • Batch Size and Campaign Planning: Pharmaceutical manufacturing operates in campaigns. The scheduling of TEPADINA production within a facility's broader manufacturing plan influences availability.

Key Takeaways

TEPADINA supply chain relies on a specialized group of API manufacturers, including Teva, Intas Pharmaceuticals, Sun Pharma, Aarti Drugs, and Cadila Healthcare. The originator product is marketed by Merck & Co. (MSD), with numerous generic versions available from companies like Teva, Sun Pharma, and Dr. Reddy's Laboratories. Stringent GMP, DMFs, and pharmacopeial standards govern API and finished product quality. Key supply chain challenges include a limited API supplier base, manufacturing complexity, product stability, and global regulatory variations. API production lead times can range from 3 to 6 months, with finished product manufacturing adding another 2 to 4 months, resulting in an overall supply chain lead time of 5 to 10 months.

FAQs

What is the primary active pharmaceutical ingredient (API) in TEPADINA?

The primary active pharmaceutical ingredient in TEPADINA is temozolomide.

How does the stability of temozolomide affect its supply chain management?

Temozolomide's sensitivity to moisture and heat necessitates strict temperature and humidity control throughout its manufacturing, storage, and distribution to prevent degradation and maintain product quality and efficacy.

Are there any major single-source dependencies in the TEPADINA API supply chain?

While not a single-source dependency, the number of qualified manufacturers for temozolomide API is limited, creating a concentrated supply chain where disruptions at a key producer could impact global availability.

What is the role of Drug Master Files (DMFs) in the TEPADINA supply chain?

Drug Master Files (DMFs) are submitted by temozolomide API manufacturers to regulatory agencies. They contain confidential details about the API manufacturing process, enabling regulatory review without revealing proprietary information to finished drug product manufacturers.

Can the lead time for TEPADINA be significantly extended by raw material shortages?

Yes, shortages of key upstream chemical precursors required for temozolomide synthesis can directly impact the API production timeline, potentially extending the overall lead time for both the API and the finished TEPADINA product.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (cGMP) regulations. Retrieved from [FDA website] [2] European Medicines Agency. (n.d.). Good manufacturing practice (GMP). Retrieved from [EMA website] [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from [ICH website] [4] Merck & Co., Inc. (n.d.). Temodar prescribing information. [5] U.S. Pharmacopeia. (n.d.). United States Pharmacopeia. Retrieved from [USP website] [6] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia. Retrieved from [EDQM website]