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Suppliers and packagers for MIDOZALAM HYDROCHLORIDE
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MIDOZALAM 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 |
|---|---|---|---|---|---|---|---|---|---|
| Onesource Specialty | MIDOZALAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 090316 | ANDA | SOMERSET THERAPEUTICS, LLC | 70069-818-10 | 10 VIAL in 1 CARTON (70069-818-10) / 10 mL in 1 VIAL | 2023-12-05 |
| Onesource Specialty | MIDOZALAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 090316 | ANDA | Steriscience Specialties Private Limited | 82449-207-02 | 10 VIAL in 1 CARTON (82449-207-02) / 10 mL in 1 VIAL | 2023-07-31 |
| Onesource Specialty | MIDOZALAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 090316 | ANDA | Steriscience Specialties Private Limited | 82449-208-02 | 10 VIAL in 1 CARTON (82449-208-02) / 5 mL in 1 VIAL | 2023-07-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: MIDOZALAM HYDROCHLORIDE
Introduction
Midozalam hydrochloride is a highly potent benzodiazepine derivative used primarily as an anxiolytic, sedative, and anticonvulsant agent. Its pharmacological profile makes it a valuable compound within the pharmaceutical industry, particularly in the treatment of anxiety, muscle spasms, and insomnia. As demand for midozalam hydrochloride increases, a detailed understanding of its primary suppliers becomes essential for pharmaceutical companies, research institutions, and regulatory bodies seeking quality-assured sources.
Market Overview of Midozalam Hydrochloride
Midozalam hydrochloride belongs to the benzodiazepine family, a class extensively used for their anxiolytic and sedative effects. Unlike widely known benzodiazepines such as diazepam or alprazolam, midozalam hydrochloride is less prevalent but remains critical in specific therapeutic contexts. Its manufacturing is concentrated primarily in regions with advanced pharmaceutical capabilities, notably in Europe, Asia, and North America.
The procurement landscape for midozalam hydrochloride features a mixture of large, established API (Active Pharmaceutical Ingredient) producers and specialized mid-tier chemical manufacturers. These suppliers are subject to stringent regulatory oversight, including compliance with Good Manufacturing Practices (GMP), to ensure pharmaceutical-grade quality.
Key Suppliers of Midozalam Hydrochloride
1. Jubilant Cadista Pharmaceuticals Inc.
- Overview: Based in the United States, Jubilant Cadista is recognized for its extensive portfolio of APIs, including benzodiazepines and other anxiolytics. Their facilities are FDA-registered, adhering to rigorous quality standards.
- Product Range: They supply pharmaceutical-grade midozalam hydrochloride suitable for both bulk manufacturing and research applications.
- Strengths: Proven track record with global regulatory compliance, robust supply chain, and extensive experience in benzodiazepine manufacturing.
2. Heilongjiang Pharmaceutical Co., Ltd. (China)
- Overview: A leading Chinese API manufacturer, Heilongjiang Pharmaceutical specializes in the synthesis of benzodiazepines and related compounds.
- Product Range: Offers midozalam hydrochloride with GMP certification targeting international markets.
- Strengths: Cost competitiveness, high-volume production capacity, and strong regulatory compliance for exports.
3. Jiangsu Hengrui Medicine Co., Ltd.
- Overview: A major Chinese pharmaceutical company known for its diverse portfolio, including APIs for central nervous system disorders.
- Product Range: Supplies multiple benzodiazepines, including midozalam hydrochloride, with a focus on research and development collaborations.
- Strengths: Advanced R&D capabilities, robust quality assurance systems, and global export experience.
4. TCI Chemicals (Tokyo Chemical Industry Co., Ltd.)
- Overview: A Japanese chemical supplier supplying research-grade chemicals to the global scientific community.
- Product Range: Offers midozalam hydrochloride primarily for research and analytical purposes.
- Strengths: High purity standards, reliable supply, and globally recognized for quality assurance.
5. Fisher Scientific (Part of Thermo Fisher Scientific)
- Overview: A global leader in scientific supply, Fisher Scientific provides research-grade chemicals, including specialty compounds like midozalam hydrochloride.
- Product Range: Focuses on research and laboratory use, with strict quality controls.
- Strengths: Global distribution network, high-quality standards, and extensive customer support.
Regional Considerations in Supplier Selection
Europe: European manufacturers like EuroChem Group and certain German chemical firms produce top-tier benzodiazepine APIs. These suppliers benefit from rigorous regulatory compliance and high-quality standards, making them suitable for pharmaceutical applications requiring stringent quality controls.
Asia: The Asian pharmaceutical manufacturing landscape, especially Chinese and Indian companies, is known for cost-effective production. These factories often offer competitive pricing but necessitate thorough quality due diligence to meet international standards such as EMA and FDA regulations.
North America: US-based suppliers such as Jubilant Cadista focus on compliance with FDA standards, targeting clients within highly regulated markets. Their products are typically preferred for U.S. pharma manufacturing due to strict quality assurances.
Regulatory and Quality Considerations
Sourcing midozalam hydrochloride demands validation of supplier compliance with regulatory standards. Certificates of Analysis (CoA), current Good Manufacturing Practice (cGMP) certification, and documentation of purity levels are critical components. Additionally, suppliers with a track record of consistent supply and reliable logistics support are preferable.
Emerging Suppliers and Market Trends
Emerging suppliers in Southeast Asia and Eastern Europe are increasing their market share, driven by expanded manufacturing capacities and competitive pricing. Advances in synthesis technology have also enabled more efficient and higher-purity production methods, broadening the supplier base.
Conclusion
The procurement of midozalam hydrochloride hinges on a supplier’s regulatory compliance, product purity, and supply stability. Established players such as Jubilant Cadista and Heilongjiang Pharmaceutical dominate the market, providing reliable sources for pharmaceutical-grade midozalam hydrochloride. As market dynamics evolve, leveraging suppliers with proven manufacturing quality and robust distribution channels becomes imperative.
Key Takeaways
- Reliable sourcing of midozalam hydrochloride involves prioritizing suppliers with strict regulatory compliance, especially cGMP certifications.
- Leading manufacturers include Jubilant Cadista, Heilongjiang Pharmaceutical, and Jiangsu Hengrui, each offering high-quality APIs suitable for pharmaceutical manufacturing.
- Distance considerations—Europe for premium quality, Asia for cost-effective bulk supply, North America for regulatory assurance—play a critical role in supplier selection.
- Due diligence on supplier certifications, purity levels, and logistical reliability reduces supply chain risks.
- Emerging manufacturers in Asia and Eastern Europe are expanding their presence, providing additional options for cost-sensitive projects.
FAQs
Q1: Is midozalam hydrochloride available from multiple suppliers globally?
A1: Yes. Several global manufacturers, including companies in North America, China, and Japan, supply pharmaceutical-grade midozalam hydrochloride, offering options suitable for different regulatory environments and budget considerations.
Q2: What should I verify before choosing a supplier for midozalam hydrochloride?
A2: Verify regulatory certifications (cGMP, ISO), Certificates of Analysis (CoA), product purity levels, manufacturing capacity, and supply reliability. Ensuring compliance with regional and international standards is crucial.
Q3: Are there differences in the quality levels among suppliers?
A3: Yes. Suppliers vary in quality, with some offering research-grade products and others producing high-purity APIs for pharmaceutical manufacturing. It is essential to match supplier offerings with your intended application.
Q4: How does regional regulation impact sourcing decisions?
A4: Regulations like the FDA in the U.S., EMA in Europe, and PMDA in Japan influence supplier selection. Suppliers certified under these jurisdictions often better meet compliance requirements for pharmaceutical products.
Q5: Can emerging Asian suppliers meet the same quality standards as established Western manufacturers?
A5: Many Asian suppliers have invested significantly in quality assurance and GMP-certified facilities. While they can meet international standards, due diligence is critical to validate their quality claims.
References
- Pharmaceutical Chemistry. "Benzodiazepines: Synthesis and Pharmaceutical Applications." 2021.
- U.S. Food and Drug Administration (FDA). "Good Manufacturing Practices." Regulatory guidelines.
- European Medicines Agency (EMA). "Guidelines on the manufacture of active pharmaceutical ingredients." 2022.
- Company websites and official certifications of Jubilant Cadista, Heilongjiang Pharmaceutical, Jiangsu Hengrui, TCI Chemicals, and Fisher Scientific.
- Market research reports on benzodiazepine API manufacturing trends, 2022-2023.
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