Suppliers and packagers for generic pharmaceutical drug: clobazam

clobazam

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alkem Labs Ltd	CLOBAZAM	clobazam	SUSPENSION;ORAL	213039	ANDA	Ascend Laboratories, LLC	67877-658-61	1 BOTTLE in 1 CARTON (67877-658-61) / 120 mL in 1 BOTTLE	2021-05-07
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833	NDA	Aquestive Therapeutics	10094-205-60	60 POUCH in 1 PACKAGE (10094-205-60) / 1 FILM in 1 POUCH (10094-205-01)	2018-11-01
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833	NDA	Aquestive Therapeutics	10094-210-60	60 POUCH in 1 PACKAGE (10094-210-60) / 1 FILM in 1 POUCH (10094-210-01)	2018-11-01
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833	NDA	Aquestive Therapeutics	10094-220-60	60 POUCH in 1 PACKAGE (10094-220-60) / 1 FILM in 1 POUCH (10094-220-01)	2018-11-01

Suppliers for the Pharmaceutical Drug Clobazam: A Comprehensive Analysis of Global Manufacturers and Market Dynamics

Clobazam, a benzodiazepine derivative, has established itself as a critical therapeutic agent for managing seizures associated with Lennox-Gastaut syndrome (LGS) and other epileptic conditions. As demand for this anticonvulsant grows, understanding the global landscape of Clobazam suppliers—including active pharmaceutical ingredient (API) manufacturers, generic drug producers, and formulation developers—becomes paramount. This report synthesizes data from regulatory filings, market analyses, and corporate announcements to provide a detailed overview of the Clobazam supply chain, regulatory milestones, and competitive dynamics.

---

Regulatory Framework and Market Entry Pathways

FDA Approvals and Generic Competition

The U.S. Food and Drug Administration (FDA) has approved multiple generic versions of Clobazam since the expiration of Lundbeck’s Onfi® exclusivity. For instance, Amneal Pharmaceuticals received approval for Clobazam tablets (10 mg and 20 mg) and oral suspension (2.5 mg/mL) in October 2018, marking one of the earliest generic entrants[2][8]. Similarly, Lupin Limited launched its generic Clobazam tablets in December 2018, capitalizing on a market with annual sales exceeding $479 million[4]. As of 2025, over 15 manufacturers, including Aurobindo Pharma, Hetero Labs, and Micro Labs, have secured FDA approvals for Clobazam formulations, fostering robust competition and price accessibility[2][9].

Drug Master Files (DMFs) and Compliance

API manufacturers must submit detailed Drug Master Files (DMFs) to regulatory agencies, such as the U.S. DMF (USDMF) or European DMF (EDMF), to certify compliance with Good Manufacturing Practices (GMP). PharmaCompass lists 16 Clobazam suppliers with active USDMFs, including Cambrex Corporation, Centaur Pharmaceuticals, and Piramal Pharma Solutions[1][3]. These filings ensure transparency in manufacturing processes, from chemical synthesis to packaging, and are critical for maintaining supply chain integrity[3][12].

---

Key Global Suppliers and Manufacturing Hubs

Leading API Manufacturers

1. EUROAPI: As a spin-off of Sanofi, EUROAPI dominates the Clobazam API market, offering both commercial sales and contract development and manufacturing organization (CDMO) services[1].
2. Hetero Drugs: This Indian multinational supplies Clobazam API to generic manufacturers worldwide, leveraging cost-efficient production facilities in Hyderabad[1][9].
3. Centaur Pharmaceuticals: With USDMF and EU-GMP certifications, Centaur exports Clobazam API to North America and Europe, emphasizing high-purity batches for pediatric formulations[1][12].

Generic Formulation Producers

• Amneal Pharmaceuticals: A first-mover in the U.S. generics market, Amneal launched Clobazam tablets and oral suspension in 2018, securing a significant market share through strategic pricing[8].
• Lupin Limited: Lupin’s FDA-approved Clobazam tablets target the adjunctive therapy segment, supported by a manufacturing network across India and the U.S.[4].
• Alkem Laboratories: Approved for Clobazam tablets (10 mg, 20 mg) and suspension (2.5 mg/mL), Alkem emphasizes scalability, with annual production capacities exceeding 500 million units[2][9].

Regional Manufacturing Centers

India emerges as a global hub for Clobazam production, housing Taj Pharmaceuticals, Healthy Inc, and Global Calcium, which collectively export APIs and finished dosages to over 50 countries[10][11][12]. These firms prioritize WHO-GMP compliance and cater to markets in Africa, Southeast Asia, and Latin America, where epilepsy treatment access remains a public health priority[10][12].

---

Market Dynamics and Growth Projections

Valuation and Competitive Pressures

The Clobazam API market was valued at $216 million in 2023, with projections suggesting a compound annual growth rate (CAGR) of 4.8% to reach $344 million by 2033[7]. Branded products like Onfi® and Sympazan® (an oral film formulation) initially drove revenue, but generics now account for 65% of U.S. prescriptions[2][6]. Price erosion, however, remains a challenge: average API costs have declined by 12% since 2020 due to oversupply from Indian and Chinese manufacturers[7][12].

Innovation in Dosage Forms

While generic tablets and suspensions dominate, Aquestive Therapeutics licenses Sympazan®, a patented oral film approved in 2018. With no generics available until at least 2040 (due to patent 11,541,002), Sympazan® targets patients with dysphagia, offering a differentiated product in a crowded market[5][6].

---

Challenges and Risk Mitigation

Supply Chain Vulnerabilities

Historical shortages, such as the 2016 Canadian crisis caused by production halts at Apotex and Teva, underscore the fragility of Clobazam supply chains[13]. To mitigate risks, regulators now mandate dual sourcing strategies, and manufacturers like MSN Laboratories maintain buffer stocks equivalent to six months of demand[9][13].

Regulatory Scrutiny

FDA warning letters to Harman Finochem (2022) and Raks Pharma (2023) for GMP violations highlight quality control risks in API production[1]. Suppliers addressing these concerns, such as Piramal Pharma Solutions, invest in advanced analytics and real-time monitoring systems to ensure batch consistency[1][3].

---

Strategic Recommendations for Stakeholders

1. Diversification of Suppliers: Procure Clobazam API from multiple GMP-certified manufacturers to avoid dependency on single sources.
2. Investment in Novel Formulations: Explore patent-protected delivery systems (e.g., extended-release tablets) to capture premium pricing segments.
3. Geographic Expansion: Target underserved regions like Sub-Saharan Africa, where epilepsy prevalence exceeds 7 per 1,000 individuals, through partnerships with local distributors[12].

---

Conclusion

The Clobazam supply ecosystem is characterized by robust generic competition, regulatory complexity, and innovation in patient-centric dosage forms. As the global burden of epilepsy rises, suppliers must balance cost efficiency with quality assurance, while stakeholders prioritize supply chain resilience to ensure uninterrupted access to this life-saving therapy.

---

Key Takeaways

• Over 15 generic Clobazam suppliers operate in the U.S., with Indian API manufacturers dominating global exports.
• Sympazan® oral film holds exclusivity until 2040, offering a niche market opportunity.
• Regulatory compliance and supply chain diversification are critical to mitigating shortages and quality risks.

FAQs

1. Which companies produce generic Clobazam tablets?
   Amneal, Lupin, and Hetero Labs are key suppliers, with FDA approvals dating to 2018–2022[2][4][9].

2. Is there a generic version of Sympazan®?
   No. Aquestive’s oral film formulation remains under patent protection until 2040[5][6].

3. What is the role of Drug Master Files (DMFs) in Clobazam supply?
   DMFs ensure API quality by detailing manufacturing processes, reviewed by regulators during generic approvals[1][3].

4. How has India influenced the Clobazam market?
   Indian firms supply 60% of global Clobazam API, leveraging cost-efficient production and regulatory expertise[10][12].

5. What caused the 2016 Clobazam shortage?
   Production halts at Apotex and Teva disrupted Canadian supplies, prompting reforms in inventory management[13].

"Generic competition has transformed Clobazam from a high-cost specialty drug to an accessible therapy, benefitting millions of epilepsy patients worldwide." – PharmaCompass Industry Report[1][3]

References

1. https://www.pharmacompass.com/manufacturers-suppliers-exporters/clobazam
2. https://www.drugs.com/availability/generic-onfi.html
3. https://www.pharmacompass.com/us-drug-master-files-dmfs/clobazam
4. https://www.lupin.com/lupin-launches-clobazam-tablets/
5. https://aquestive.com/aquestive-therapeutics-licenses-sympazan-clobazam-oral-film-to-assertio-holdings-inc/
6. https://www.drugs.com/availability/generic-sympazan.html
7. https://datahorizzonresearch.com/clobazam-api-market-10146
8. https://investors.amneal.com/news/press-releases/press-release-details/2018/Amneal-Announces-Approval-and-Launch-of-Clobazam-Tablets-and-Clobazam-Oral-Suspension/default.aspx
9. https://pharsight.greyb.com/ingredient/clobazam-patent-expiration
10. https://www.tajdrug.com/Clobazam.htm
11. https://healthyinc.co.in/product/clobazam-tablets-who-gmp-manufacturer-supplier-export-healthy-inc/
12. https://www.globalcalcium.com/products/clobazam
13. https://epilepsyontario.org/wp-content/uploads/2016/06/Clobazam-Shortage_ver6_June-20_2016_FINAL.pdf