Bulk Pharmaceutical API Sources for clobazam

Bulk Pharmaceutical API Sources for clobazam

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C8414_SIGMA
AKos Consulting & Solutions		AKOS025401921
Clearsynth		CS-O-11314
MedChemexpress MCE		HY-A0041
AbaChemScene		CS-6756

Bulk Active Pharmaceutical Ingredient (API) Sources for Clobazam

Last updated: February 19, 2026

This report identifies key bulk Active Pharmaceutical Ingredient (API) manufacturers and suppliers for Clobazam, a benzodiazepine used in the treatment of epilepsy and anxiety disorders. The analysis focuses on global suppliers with established manufacturing capabilities and regulatory compliance.

What is Clobazam?

Clobazam is a 1,5-benzodiazepine, distinct from the more common 1,4-benzodiazepines. Its mechanism of action involves enhancing the activity of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) in the brain. This leads to a reduction in abnormal electrical activity, effectively controlling seizures and alleviating anxiety. Clobazam is available in various formulations, including tablets and oral suspensions. The global market for antiepileptic drugs, which includes Clobazam, is projected to reach \$28.6 billion by 2027, driven by increasing epilepsy prevalence and neurological disorder diagnoses [1].

Key API Manufacturers and Suppliers

The following entities are identified as significant suppliers of bulk Clobazam API. These suppliers have demonstrated capacity for large-scale production and often possess certifications required for regulated markets, such as Good Manufacturing Practices (GMP).

Global API Production Landscape

The production of Clobazam API is concentrated among a select group of manufacturers, primarily located in India and China, which are major hubs for pharmaceutical API production due to cost advantages and established chemical synthesis expertise. European and North American manufacturers also exist but may focus on higher-value, specialty APIs or serve local markets.

Company Name	Location	Primary Offerings	Regulatory Status	Notes
Sun Pharmaceutical Industries Ltd.	India	Clobazam API, Finished Dosage Forms	US FDA, EDQM, WHO GMP	A leading global pharmaceutical company with significant API manufacturing capacity.
Dr. Reddy's Laboratories Ltd.	India	Clobazam API	US FDA, EDQM, WHO GMP	A prominent Indian multinational pharmaceutical company with a strong API segment.
Laurus Labs Limited	India	Clobazam API	US FDA, EDQM, WHO GMP	Specializes in APIs and finished dosage forms, with a focus on active pharmaceutical ingredients.
Divi's Laboratories Limited	India	Clobazam API	US FDA, EDQM, WHO GMP	A major API manufacturer known for its large-scale production capabilities and quality standards.
Teva Pharmaceutical Industries Ltd.	Israel	Clobazam API (via subsidiaries/partnerships)	US FDA, EDQM	A global leader in generics and APIs, likely sources or manufactures Clobazam through its extensive network.
Jiangsu HEC Pharmaceutical Co., Ltd.	China	Clobazam API	CFDA, potential for other international certifications	A significant Chinese pharmaceutical manufacturer with broad API capabilities.
Anhui Fengyuan Pharmaceutical Co., Ltd.	China	Clobazam API	CFDA, potential for other international certifications	Engaged in the production of various pharmaceutical intermediates and APIs.

Key Geographic Markets for API Sourcing

• India: Dominates global API production due to competitive pricing, robust manufacturing infrastructure, and a large pool of skilled chemists. Indian manufacturers frequently hold US FDA and European Directorate for the Quality of Medicines & HealthCare (EDQM) certifications.
• China: A substantial contributor to API supply, offering competitive pricing. Compliance with international standards is increasingly a focus for Chinese manufacturers aiming for regulated markets.
• Europe: European-based manufacturers may offer Clobazam API with a focus on stringent quality control and regulatory adherence, though often at a higher price point.

Regulatory Considerations for Clobazam API

Procurement of Clobazam API requires adherence to strict regulatory guidelines to ensure product safety, efficacy, and compliance in target markets.

Good Manufacturing Practices (GMP)

All API suppliers must operate under current Good Manufacturing Practices (cGMP). For Clobazam destined for regulated markets like the United States and Europe, this typically means compliance with US FDA cGMP regulations (21 CFR Parts 210 and 211) and EU GMP guidelines. Manufacturers often undergo inspections by regulatory bodies to verify compliance.

Drug Master Files (DMFs)

Suppliers frequently maintain Drug Master Files (DMFs) for their Clobazam API. A DMF is a submission to a regulatory agency (e.g., US FDA) that provides detailed information about the manufacturing process, facilities, and controls used for the API. This allows drug product manufacturers to reference the DMF in their marketing applications (e.g., New Drug Applications or Abbreviated New Drug Applications) without disclosing proprietary manufacturing information.

• US FDA DMFs: Contain comprehensive data on API synthesis, characterization, impurities, stability, and packaging.
• European EDQM CEPs: A Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) issued by EDQM demonstrates that the quality of a substance is suitably controlled by the relevant European Pharmacopoeia monograph.

Pharmacopoeial Standards

Clobazam API must meet the specifications outlined in relevant pharmacopoeias, which include:

• United States Pharmacopoeia (USP): Sets standards for identity, strength, quality, and purity of medicines.
• European Pharmacopoeia (Ph. Eur.): Provides harmonized quality standards for medicines across European countries.
• Japanese Pharmacopoeia (JP): Sets similar standards for the Japanese market.

Suppliers must provide Certificates of Analysis (CoAs) for each batch of API, confirming compliance with these pharmacopoeial standards.

Supply Chain Dynamics and Risk Assessment

The Clobazam API supply chain involves multiple stages, from raw material sourcing to finished API production and distribution. Understanding these dynamics is crucial for supply chain resilience.

Raw Material Sourcing

The synthesis of Clobazam involves several chemical intermediates. The availability and pricing of these precursor chemicals can impact the overall cost and continuity of API production. Geopolitical factors, environmental regulations affecting intermediate production, and the concentration of intermediate suppliers can pose risks.

Manufacturing Capacity and Lead Times

• Capacity: Manufacturers like Sun Pharma and Dr. Reddy's have demonstrated significant capacity for large-volume API production. However, specific production slots for Clobazam can be subject to demand and existing production schedules.
• Lead Times: Typical lead times for bulk Clobazam API can range from 8 to 16 weeks from order placement to delivery, depending on the supplier, order volume, and current production commitments. Urgent orders may incur premium pricing.

Quality Control and Impurity Profiling

Robust quality control is paramount. This includes:

• Impurity Identification: Identifying and quantifying process-related impurities and degradation products is critical. Regulatory agencies scrutinize impurity profiles.
• Stability Studies: Comprehensive stability data under various storage conditions are required to establish shelf-life and ensure API integrity.

Supply Chain Risks

Potential risks in the Clobazam API supply chain include:

• Geopolitical Instability: Disruptions in key sourcing regions (e.g., India, China) due to political events or trade disputes.
• Regulatory Changes: New or revised regulatory requirements in manufacturing or target markets can necessitate process modifications or additional testing.
• Natural Disasters: Events that impact manufacturing facilities or logistics infrastructure.
• Supplier Reliance: Over-reliance on a single supplier or a limited number of suppliers for critical intermediates or the API itself.
• Intellectual Property (IP) Landscape: While Clobazam is an older drug, understanding the patent landscape for manufacturing processes can be relevant for process innovation and sourcing. The original patents for Clobazam have long expired, allowing for generic production.

Market Outlook for Clobazam API

The demand for Clobazam API is closely linked to the market for Clobazam-containing finished drug products.

Drivers of Demand

• Epilepsy Prevalence: Clobazam is a recognized adjunctive therapy for certain types of epilepsy, particularly Lennox-Gastaut syndrome. Increasing diagnosis rates of epilepsy worldwide contribute to sustained demand.
• Anxiety Treatment: Its use in managing anxiety disorders, especially in contexts where other treatments may be less suitable, also supports market demand.
• Generic Market Growth: The established efficacy and off-patent status of Clobazam fuel a robust generic market, driving demand for cost-effective API from multiple suppliers.
• Pediatric Use: Clobazam's availability in liquid formulations makes it suitable for pediatric patients, a significant segment in epilepsy management.

Pricing Trends

API pricing for Clobazam is influenced by several factors:

• Manufacturing Costs: Raw material costs, labor, energy, and compliance costs are primary determinants.
• Scale of Production: Larger order volumes generally command lower per-unit pricing.
• Supplier Competition: The presence of multiple GMP-certified suppliers, particularly from India and China, creates competitive pricing.
• Regulatory Compliance: Suppliers with advanced regulatory filings (e.g., approved DMFs in multiple regions) may command a premium for the assurance of compliance.
• Market Demand: Fluctuations in finished product demand directly impact API demand and, consequently, pricing.

Average pricing for bulk Clobazam API can range from \$150 to \$400 per kilogram, depending on the factors listed above and the specific purity and certification levels required.

Key Takeaways

• Clobazam API production is primarily concentrated in India and China, with Sun Pharmaceutical Industries, Dr. Reddy's Laboratories, and Divi's Laboratories being significant suppliers.
• Regulatory compliance, particularly US FDA and EDQM GMP certifications and the availability of DMFs, is critical for market access.
• Supply chain risks include geopolitical instability, regulatory changes, and reliance on a limited number of raw material sources.
• Demand for Clobazam API is driven by its established role in epilepsy and anxiety treatment, supported by a growing generic market.
• API pricing is competitive, influenced by manufacturing costs, scale, and regulatory standing, with typical ranges between \$150-\$400/kg.

Frequently Asked Questions

What is the primary therapeutic indication for Clobazam API?

Clobazam API is primarily used in the manufacturing of finished drug products for the treatment of epilepsy, particularly as an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome, and for the management of anxiety disorders [2].

Which regulatory bodies are most critical for Clobazam API suppliers to comply with?

Suppliers must comply with Good Manufacturing Practices (GMP) as stipulated by the U.S. Food and Drug Administration (FDA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM). Compliance with pharmacopoeial standards such as the United States Pharmacopoeia (USP) and the European Pharmacopoeia (Ph. Eur.) is also essential [3].

What are the main risks associated with sourcing Clobazam API from emerging markets?

Key risks include potential supply chain disruptions due to geopolitical factors or trade policies, and the need for rigorous due diligence to ensure consistent quality and regulatory compliance from manufacturers who may have varying levels of adherence to international standards [4].

How does the patent status of Clobazam affect API sourcing?

Clobazam is an older drug with expired primary patents. This has led to a robust generic market, increasing competition among API manufacturers and generally leading to more competitive pricing for bulk API [5].

What is a Drug Master File (DMF) and why is it important for Clobazam API?

A Drug Master File (DMF) is a confidential submission to regulatory agencies (like the FDA) that contains detailed information about the manufacturing process, facilities, and quality controls for an API. It is important for Clobazam API because it allows finished drug product manufacturers to reference this data in their regulatory applications without needing access to the API manufacturer's proprietary information, streamlining the approval process [6].

---

Citations

[1] Grand View Research. (2023). Antiepileptic Drugs Market Size, Share & Trends Analysis Report By Drug Class (Barbiturates, Benzodiazepines, Hydantoins, Others), By Condition (Epilepsy, Neuropathic Pain, Anxiety Disorders), By Region, And Segment Forecasts, 2020 - 2027.

[2] U.S. Food and Drug Administration. (2019). ONFI (Clobazam) Prescribing Information.

[3] European Directorate for the Quality of Medicines & HealthCare (EDQM). (n.d.). Certificate of Suitability. Retrieved from https://www.edqm.eu/en/certificate-suitability-cep

[4] World Health Organization. (2010). Good manufacturing practices for pharmaceutical products: main principles. WHO Technical Report Series, No. 961.

[5] Darrow, J. M. (2009). Patent expiration and generic entry: Impact on pharmaceutical prices. Journal of Pharmaceutical Economics, 1(2), 117-126.

[6] U.S. Food and Drug Administration. (2020). Drug Master Files. Retrieved from https://www.fda.gov/drugs/drug-master-files/drug-master-files