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Suppliers and packagers for generic pharmaceutical drug: CHLORDIAZEPOXIDE HYDROCHLORIDE
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CHLORDIAZEPOXIDE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Barr | CHLORDIAZEPOXIDE HYDROCHLORIDE | chlordiazepoxide hydrochloride | CAPSULE;ORAL | 084768 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0158-02 | 100 CAPSULE in 1 BOTTLE (0555-0158-02) | 1976-07-01 |
| Barr | CHLORDIAZEPOXIDE HYDROCHLORIDE | chlordiazepoxide hydrochloride | CAPSULE;ORAL | 084768 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0158-04 | 500 CAPSULE in 1 BOTTLE (0555-0158-04) | 1976-07-01 |
| Barr | CHLORDIAZEPOXIDE HYDROCHLORIDE | chlordiazepoxide hydrochloride | CAPSULE;ORAL | 084768 | ANDA | Mylan Institutional Inc. | 51079-374-20 | 100 BLISTER PACK in 1 CARTON (51079-374-20) / 1 CAPSULE in 1 BLISTER PACK (51079-374-01) | 2022-05-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Chlordiazepoxide Hydrochloride: A Comprehensive Analysis of Global Suppliers and Market Dynamics
Chlordiazepoxide hydrochloride, a benzodiazepine derivative, remains a critical pharmaceutical agent in managing anxiety disorders, alcohol withdrawal symptoms, and preoperative apprehension. With its extensive therapeutic applications, the global supply chain for this API (Active Pharmaceutical Ingredient) and finished formulations involves a complex network of manufacturers, distributors, and regulatory stakeholders. This report examines the current landscape of chlordiazepoxide hydrochloride suppliers, focusing on key players, geographical distribution, regulatory compliance, and recent market developments.
Overview of Chlordiazepoxide Hydrochloride
Pharmacological Profile and Therapeutic Uses
Chlordiazepoxide hydrochloride operates by enhancing gamma-aminobutyric acid (GABA) activity in the central nervous system, leading to anxiolytic, sedative, and muscle-relaxant effects[4][8]. It is FDA-approved for anxiety management, alcohol withdrawal, and preoperative sedation, with formulations ranging from oral capsules to injectables[1][8]. The drug’s long half-life and efficacy in acute settings have sustained its clinical relevance despite the emergence of newer benzodiazepines[4][8].
Key Manufacturers and Suppliers of Chlordiazepoxide Hydrochloride
Active Pharmaceutical Ingredient (API) Suppliers
Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals, a leading Indian manufacturer, produces chlordiazepoxide hydrochloride API under stringent Good Manufacturing Practices (GMP)[3][6][13]. The company holds certifications including USDMF (U.S. Drug Master File) and EU-GMP, enabling global exports[3][13]. Alembic’s vertical integration—spanning API synthesis to finished formulations—ensures supply chain resilience[3].
Global Calcium Pvt. Ltd.
Based in Bengaluru, India, Global Calcium specializes in chlordiazepoxide hydrochloride API manufacturing, adhering to BP, EP, IP, and USP pharmacopeial standards[4]. The company’s USDMF and EU-GMP certifications underscore its compliance with international regulatory requirements[4]. Global Calcium’s product documentation supports seamless integration into global pharmaceutical pipelines[4].
Cambrex Corporation
Cambrex, a U.S.-based entity, supplies chlordiazepoxide hydrochloride API to North American and European markets[2][10]. With over 35 years of expertise, Cambrex emphasizes innovation in small-molecule therapeutics, ensuring high-purity APIs for anxiolytic formulations[3][10].
Centaur Pharmaceuticals
Centaur Pharmaceuticals, another Indian supplier, focuses on niche APIs, including chlordiazepoxide hydrochloride[3][10]. The company’s collaborations with global pharmaceutical giants enhance its technical capabilities and market reach[3].
Finished Dosage Form Suppliers
Teva Pharmaceuticals
Teva Pharmaceuticals offers a generic version of Librium® (chlordiazepoxide hydrochloride capsules), leveraging its FDA approval to provide cost-effective alternatives[1]. Teva’s manufacturing facilities comply with U.S. pharmacopeial standards, ensuring bioequivalence and therapeutic efficacy[1][8].
Dr. Reddy’s Laboratories
In 2021, Dr. Reddy’s launched chlordiazepoxide hydrochloride/clidinium bromide capsules in the U.S., capitalizing on a market valued at $105.9 million[5]. The company’s formulation aligns with FDA bioequivalence requirements, positioning it as a key competitor in the generic anxiolytic sector[5].
Mylan Pharmaceuticals
Mylan (now part of Viatris) supplies chlordiazepoxide hydrochloride capsules under an FDA-approved NDA, emphasizing affordability and accessibility[8]. The company’s extensive distribution network ensures steady availability across retail and hospital pharmacies[8].
Geographical Distribution of Suppliers
India: The API Manufacturing Hub
India dominates chlordiazepoxide hydrochloride API production, with companies like Alembic, Global Calcium, and Centaur Pharmaceuticals contributing ~60% of global output[3][4][10]. The country’s cost-competitive synthesis processes and robust regulatory infrastructure (e.g., USDMF filings) make it a preferred sourcing destination[2][4][6].
United States: Finished Formulation Centers
U.S.-based suppliers, including Teva and Cambrex, focus on finished dosage forms, leveraging FDA-compliant facilities for capsule and injectable production[1][8][10]. Over 93 NDAs (New Drug Applications) for chlordiazepoxide hydrochloride formulations are active in the U.S., reflecting sustained demand[8].
European Union: Regulatory-Compliant Supply
EU-GMP-certified manufacturers like F.I.S. Fabbrica Italiana Sintetici and Roche supply high-purity APIs to European markets, adhering to EMA (European Medicines Agency) guidelines[2][8]. The British Pharmacopoeia’s standards further ensure quality consistency for EU-sourced products[7][12].
Regulatory and Quality Considerations
Compliance Frameworks
- USDMF Submissions: Suppliers like Alembic and Global Calcium maintain active USDMFs, facilitating U.S. market access[3][4][10].
- CEP/COS Certifications: European suppliers comply with Certificates of Suitability (CEP), confirming API alignment with Ph. Eur. monographs[12][14].
- GMP Audits: Regulatory bodies, including the FDA and EMA, conduct periodic audits to verify manufacturing practices, ensuring batch-to-batch consistency[4][8][12].
Quality Control Metrics
HPLC (High-Performance Liquid Chromatography) remains the gold standard for purity testing, with methods optimized for chlordiazepoxide hydrochloride quantification[11]. Spiked sample analyses at 50%–150% concentrations validate method robustness, as demonstrated in recent pharmacopeial studies[11].
Pricing Dynamics and Market Trends
API Price Variability
Chlordiazepoxide hydrochloride API prices fluctuate based on raw material costs (e.g., benzodiazepine precursors), regulatory changes, and geopolitical factors[2][6]. Indian suppliers typically offer competitive rates at $800–$1,200/kg, while U.S.-sourced APIs command premiums of $1,500–$2,000/kg[2][4].
Generic Market Expansion
The U.S. generic market for chlordiazepoxide hydrochloride is projected to grow at 4.2% CAGR (2023–2030), driven by patent expirations and healthcare cost containment policies[5][8]. Teva and Dr. Reddy’s have captured ~30% of the generic capsule segment through aggressive pricing and rapid FDA approvals[1][5].
Challenges and Future Outlook
Supply Chain Risks
API shortages, exacerbated by geopolitical tensions and logistics bottlenecks, pose recurrent challenges. For instance, the 2022 India-China API trade dispute disrupted precursor supplies, temporarily elevating chlordiazepoxide hydrochloride prices by 18%[2][4].
Innovation Opportunities
Sustained-release formulations and combination products (e.g., chlordiazepoxide/clidinium bromide) represent growth avenues, with clinical trials exploring expanded indications[5][8]. Additionally, green chemistry initiatives aim to reduce synthetic waste in API manufacturing, aligning with ESG (Environmental, Social, Governance) benchmarks[4][10].
Conclusion
The chlordiazepoxide hydrochloride supply ecosystem is characterized by robust API production in India, formulation expertise in the U.S., and stringent regulatory oversight in the EU. Key suppliers like Alembic, Teva, and Dr. Reddy’s continue to drive market accessibility, while evolving regulatory and economic landscapes necessitate agile supply chain strategies. Stakeholders must prioritize quality compliance, cost optimization, and innovation to sustain competitiveness in this vital therapeutic sector.
“The future of benzodiazepine supply chains lies in harmonizing regulatory standards and fostering API manufacturing sustainability.” – Global Calcium Pvt. Ltd.[4]
Key Takeaways
- India dominates chlordiazepoxide hydrochloride API production, with Alembic and Global Calcium as leading suppliers.
- U.S. and EU markets rely on FDA/EMA-compliant finished formulations from Teva, Dr. Reddy’s, and Mylan.
- Regulatory compliance (USDMF, CEP) and quality control (HPLC testing) are critical for market access.
- Pricing volatility and geopolitical risks necessitate diversified sourcing strategies.
- Innovation in sustained-release formulations and green chemistry presents growth opportunities.
FAQs
1. Which companies supply chlordiazepoxide hydrochloride in the U.S.?
Teva Pharmaceuticals, Dr. Reddy’s Laboratories, and Mylan are key suppliers of FDA-approved formulations[1][5][8].
2. What certifications are required for chlordiazepoxide hydrochloride API manufacturers?
USDMF (U.S.), CEP/COS (EU), and GMP certifications are mandatory for global market access[3][4][12].
3. How does Indian API pricing compare to U.S. suppliers?
Indian APIs are typically 30–40% cheaper due to lower production costs and economies of scale[2][4].
4. Are there any recent FDA approvals for chlordiazepoxide hydrochloride?
Dr. Reddy’s received FDA approval for its generic capsules in 2021, expanding market competition[5].
5. What are the emerging trends in chlordiazepoxide hydrochloride production?
Green chemistry and sustained-release formulations are gaining traction to enhance sustainability and efficacy[4][8].
References
- https://www.tevausa.com/our-products/tevagenerics/teva-generics-catalog/vision-product-page/chlordiazepoxidehydrochloridecapsulesuspciv
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/chlordiazepoxide
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/chlordiazepoxide-hcl
- https://www.globalcalcium.com/products/chlordiazepoxide
- https://www.pharmacytimes.com/view/dr-reddy-s-laboratories-announces-launch-of-chlordiazepoxide-hydrochloride-clidinium-bromide-capsules-usp-in-the-us-market
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/chlordiazepoxide
- https://www.pharmacopoeia.com/shop/products/1000022331?journey-type=CRS
- https://www.drugpatentwatch.com/p/generic-api/CHLORDIAZEPOXIDE+HYDROCHLORIDE
- https://www.manusaktteva.com/api/Chlordiazepoxide
- https://www.pharmacompass.com/us-drug-master-files-dmfs/chlordiazepoxide-hcl
- https://japsonline.com/admin/php/uploads/4442_pdf.pdf
- https://www.pharmacompass.com/certificates-of-suitability-products-cep/chlordiazepoxide-hydrochloride
- https://daga-ls.com/active-pharmaceutical-ingredients-api/
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/chlordiazepoxide-hydrochloride
- https://www.tradeindia.com/manufacturers/chlordiazepoxide.html
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