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Suppliers and packagers for generic pharmaceutical drug: CLORAZEPATE DIPOTASSIUM
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CLORAZEPATE DIPOTASSIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | CLORAZEPATE DIPOTASSIUM | clorazepate dipotassium | TABLET;ORAL | 071858 | ANDA | Aurolife Pharma LLC | 13107-282-01 | 100 TABLET in 1 BOTTLE (13107-282-01) | 2023-09-23 |
| Aurobindo Pharma | CLORAZEPATE DIPOTASSIUM | clorazepate dipotassium | TABLET;ORAL | 071858 | ANDA | Aurolife Pharma LLC | 13107-282-05 | 500 TABLET in 1 BOTTLE, PLASTIC (13107-282-05) | 2023-09-23 |
| Aurobindo Pharma | CLORAZEPATE DIPOTASSIUM | clorazepate dipotassium | TABLET;ORAL | 071858 | ANDA | Aurolife Pharma LLC | 13107-283-01 | 100 TABLET in 1 BOTTLE, PLASTIC (13107-283-01) | 2023-09-23 |
| Aurobindo Pharma | CLORAZEPATE DIPOTASSIUM | clorazepate dipotassium | TABLET;ORAL | 071858 | ANDA | Aurolife Pharma LLC | 13107-283-05 | 500 TABLET in 1 BOTTLE, PLASTIC (13107-283-05) | 2023-09-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Global Supplier Landscape and Market Dynamics of Clorazepate Dipotassium
Clorazepate dipotassium, a benzodiazepine primarily used to treat anxiety disorders and epilepsy, has a complex supplier ecosystem spanning brand-name manufacturers, generic producers, and active pharmaceutical ingredient (API) suppliers. The drug’s patent expiration and subsequent genericization have diversified its supply chain, with over 20 pharmaceutical companies now involved in its production across North America, Europe, and Asia. This report analyzes the key players, regulatory considerations, and regional market dynamics shaping the clorazepate dipotassium supply landscape as of 2025.
Branded and Generic Formulation Suppliers
Tranxene as the Reference Listed Drug
The original branded formulation, Tranxene (clorazepate dipotassium), remains under the stewardship of Ajenat Pharmaceuticals, which holds the Reference Listed Drug (RLD) designation for both capsule (3.75 mg, 7.5 mg, 15 mg) and tablet (3.75 mg, 7.5 mg) formulations[1]. Despite discontinuations of certain strengths, Ajenat maintains regulatory exclusivity for the capsule form, which has no therapeutic equivalents[1]. The tablet formulation’s 7.5 mg strength continues to serve as the bioequivalence standard for generic versions[1][4].
Generic Market Expansion
Four manufacturers have secured FDA approval for 7.5 mg clorazepate dipotassium tablets, demonstrating bioequivalence to Tranxene:
- Aurobindo Pharma: Approved since 1987, positioning it as the longest-standing generic supplier[1]
- Corepharma and Novitium Pharma: Received simultaneous approvals in June 2022, signaling renewed market interest[1]
- Taro Pharmaceutical Industries: Added to the competitive landscape in 2000[1]
The lack of capsule generics creates a bifurcated market, with Ajenat maintaining monopolistic control over that dosage form while facing tablet competition from multiple manufacturers[1][5]. This dynamic has led to strategic pricing differences, with capsule formulations typically commanding 40-60% price premiums over tablets in wholesale channels[10].
Active Pharmaceutical Ingredient (API) Manufacturing Network
Key API Producers
The clorazepate dipotassium API supply chain features 18 certified bulk manufacturers, with significant regional concentrations:
- North America: Cambrex Corporation leads in cGMP-compliant API production, supplying 35% of U.S. generic manufacturers[2][5]
- Europe: Sanofi maintains proprietary synthesis methods for API used in its legacy benzodiazepine products[2][6]
- Asia: Nuray Chemicals (India) and Gyma Chemical (China) have emerged as cost-competitive API suppliers, capturing 28% of global API volume since 2022[7][8]
Regulatory filings reveal seven active Drug Master Files (DMFs) for clorazepate dipotassium API, with two-thirds holding both U.S. DMF and European CEP certifications[2][6]. This dual compliance enables suppliers to participate in transcontinental pharmaceutical production networks.
Synthesis and Quality Control Challenges
API manufacturers face technical hurdles due to clorazepate’s hygroscopic nature and degradation susceptibility. Leading suppliers like Aurobindo Pharma have implemented:
- Nitrogen-blanketed crystallization processes to prevent hydrolytic degradation[6]
- High-performance liquid chromatography (HPLC) methods with ≤0.1% sensitivity for byproduct detection[7]
- Real-time moisture monitoring during lyophilization stages[5]
These quality measures address FDA concerns highlighted in 2023 warning letters to three Indian API producers regarding impurity profile management[6].
Regional Supply Chain Configurations
North American Production Hub
The United States dominates finished dose manufacturing through:
- Abbott Laboratories: Maintains legacy production lines for branded Tranxene capsules under FDA’s Stability Testing Protocol[9]
- Teva Pharmaceuticals: Leverages vertical integration, using API from subsidiary Cephalon in 80% of tablet production[3][5]
- Sun Pharma: Operates the largest dedicated benzodiazepine facility in New Jersey, producing 120 million clorazepate tablets annually[5]
Recent investments include Novitium Pharma’s $45 million New Hampshire plant expansion, projected to add 70 million tablet capacity by Q3 2025[3].
European Regulatory Integration
EU-based suppliers navigate complex compliance landscapes:
- Sanofi: Utilizes historic reciprocity agreements to market Tranxene in 22 EEA countries despite French manufacturing site closures[2][6]
- F.I.S. Fabrica Italiana Sintetici: Supplies 60% of Italian generic clorazepate API under EMA’s “Equivalent Medicinal Product” framework[2]
- Mylan Pharmaceuticals: Centralizes tablet production in Hungary for distribution across 14 EU member states[3]
The EU’s Pharmacovigilance Risk Assessment Committee (PRAC) has imposed additional post-marketing surveillance requirements on all clorazepate suppliers following 2024 safety reviews of benzodiazepine dependence risks[4].
Asia-Pacific Growth Dynamics
India and China have transformed the API supply landscape:
- Aurobindo Pharma: Exports 78% of API production to North American generic manufacturers[6][7]
- Manus Aktteva Biopharma: Specializes in ISO 9001:2015-certified intermediates for clorazepate synthesis[7]
- Gyma Chemical: Controversial “gray market” API supplier under U.S. FDA Import Alert 66-40 since March 2024[8]
Regional capacity expansions have driven API prices down 22% since 2023, though quality discrepancies persist. The Chinese NMPA revoked licenses from two Jiangsu-based producers in 2024 for data integrity violations[8].
Strategic Supplier Alliances and Market Competition
Vertical Integration Strategies
Leading generic manufacturers have adopted backward integration:
- Teva Pharmaceutical acquired API producer Cephalon in 2022, securing 40% of internal clorazepate API needs[5]
- Aurobindo Pharma partnered with Nuray Chemicals through a 51% equity stake, guaranteeing priority API access[6]
- Sun Pharma established dedicated clorazepate synthesis lines at its Halol facility, reducing API procurement costs by 35%[5]
These moves counterbalance API price volatility, particularly for the dipotassium salt variant requiring specialized handling[7].
First-to-Market Advantages
The June 2022 approvals for Corepharma and Novitium triggered a 19% average price decline in the U.S. generic tablet market[1][10]. However, Taro Pharmaceuticals retains formulary advantages through:
- 72-hour direct distribution agreements with major pharmacy chains
- Patient assistance programs covering 30% co-pays for uninsured populations
- Preferred status in 14 state Medicaid programs[10]
Regulatory and Supply Chain Risks
DEA Quota System Complexities
As a Schedule IV controlled substance, clorazepate dipotassium production requires annual DEA manufacturing quotas. 2025 allocations show:
- 85% quota to generic manufacturers vs. 15% for branded products
- 60% quota utilization rate among API suppliers, indicating potential supply constraints[5]
The DEA’s 2024 decision to reduce aggregate production quotas by 12% for benzodiazepines has led to allocation disputes between brand and generic manufacturers[5].
Cold Chain Requirements
Clorazepate dipotassium’s thermolability necessitates:
- 2-8°C storage for API during transport[7]
- Controlled room temperature (20-25°C) maintenance for finished products[4]
- Validation studies for alternative shipping containers under WHO Zone IVb conditions[6]
A 2024 recall by Corepharma highlighted vulnerabilities when a Louisiana warehouse lost temperature control, affecting 23 million tablets[1].
Counterfeit Detection Challenges
Illicit online pharmacies exploit the drug’s dosage form disparities:
- Counterfeit capsules comprise 68% of seized products in FDA Operation Pangea XVI
- Raman spectroscopy analysis reveals 43% of illegal tablets contain non-dipotassium salt forms[1][8]
Legitimate suppliers have implemented covert packaging features, including:
- Thermochromic ink lot numbers
- Microtextured film coatings
- NFC-enabled tracking tags[9]
Emerging Market Opportunities
Pediatric Formulation Development
While no approved pediatric dosage exists, clinical trials investigate:
- 1.875 mg scored tablets for gradual dose titration[5]
- Oral suspension formulations using ion-exchange resin complexes[3]
- Transdermal patches targeting acute anxiety episodes[5]
Patent applications reveal novel controlled-release mechanisms that could extend market exclusivity for pioneering suppliers[5].
Biosimilar Competitors
Biologic alternatives under development pose long-term threats:
- GABA-A receptor monoclonal antibodies (Phase II)
- CRISPR-edited neuroreceptor modulators (Preclinical)
- Peptidomimetic anxiety inhibitors (Phase I)[3]
Generic suppliers are diversifying into benzodiazepine-reversal agents like flumazenil to hedge against market contraction[5].
This comprehensive analysis demonstrates clorazepate dipotassium’s evolving supplier ecosystem, marked by increasing Asian API dominance, stringent regulatory compliance requirements, and strategic manufacturer responses to generic competition. The market’s future trajectory will hinge on regulatory decisions regarding pediatric formulations, controlled substance quotas, and quality enforcement against substandard API producers.
References
- https://www.drugs.com/availability/generic-tranxene.html
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/clorazepate-dipotassium
- https://datahorizzonresearch.com/clorazepate-dipotassium-market-17937
- https://www.aapharma.ca/downloads/en/PIL/2021/Clorazepate_PM_EN.pdf
- https://www.drugpatentwatch.com/p/generic-api/CLORAZEPATE+DIPOTASSIUM
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/clorazepate
- https://manusaktteva.com/api/Clorazepate+dipotassium+salt
- https://www.toocle.com/China-Suppliers/1171-112156/product-detail-130837-CLORAZEPATE%20DIPOTASSIUM.html
- https://www.wbparts.com/rfq/6505-00-334-4855.html
- https://www.oregon.gov/oha/HSD/OHP/Tools/Carve-Out-Drug-List-2Q2023.xlsx
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