Bulk Pharmaceutical API Sources for DIZAC

Bulk Pharmaceutical API Sources for DIZAC

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		D0899_SIGMA
Hangzhou APIChem Technology		AC-10561
AKos Consulting & Solutions		AKOS003367969
Vitas-M Laboratory		STK735517
Amadis Chemical		A826456

Bulk Active Pharmaceutical Ingredient (API) Sources for DIZAC (Dizepam Hydrochloride)

Last updated: July 29, 2025

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Introduction

Dizepam hydrochloride, known commercially as DIZAC, is a benzodiazepine derivative primarily used for its anxiolytic, sedative, and anticonvulsant properties. As a controlled substance, the sourcing of high-quality bulk API is central to pharmaceutical manufacturing, regulatory compliance, and supply chain integrity. Identifying reliable API suppliers is crucial for pharmaceutical companies and generic drug manufacturers aiming to meet quality standards, cost-efficiency, and regulatory demands.

Overview of DIZAC API Market Landscape

The market landscape for DIZAC API is characterized by limited but specialized suppliers, often situated in countries with established pharmaceutical manufacturing capabilities in Asia and Europe. Unlike mass production APIs, DIZAC's active ingredient sourcing involves stringent quality control, given benzodiazepines' regulatory oversight. Accordingly, suppliers must adhere to Good Manufacturing Practices (GMP) and possess relevant certification.

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Major API Suppliers for DIZAC

1. Chinese API Manufacturers

China remains a dominant hub for the production of generic APIs, including benzodiazepines like Dizepam Hydrochloride, due to its extensive API manufacturing infrastructure and cost advantages.

• Zhejiang Hisun Pharmaceutical Co., Ltd.
  A leading producer recognized for high-quality benzodiazepine APIs. The company holds GMP certification and supplies to global markets, including North America and Europe. Their compliance with international standards is verified through regulatory audits.

• Qingdao Eastchem Co., Ltd.
  Specialized in the production of benzodiazepine APIs with a broad product portfolio. Eastchem emphasizes quality assurance, customer service, and regulatory compliance, making it a reputable choice for bulk API procurement.

• Jiangsu Hengrui Medicine Co., Ltd.
  An innovator with a broad API manufacturing portfolio, Hengrui supplies benzodiazepine APIs globally, including Dizepam Hydrochloride, adhering to stringent manufacturing standards.

2. Indian API Manufacturers

India's API industry is renowned for compliant manufacturing practices and a comprehensive regulatory framework.

• Bidachem Ltd.
  A well-established manufacturer with GMP-certified facilities, Bidachem supplies benzodiazepine APIs, including Dizepam Hydrochloride, focusing on quality and consistency.

• Sun Pharmaceutical Industries Ltd.
  Although primarily a finished dosage form producer, Sun Pharmaceutical's API division supplies benzodiazepine APIs compliant with global standards, serving large international clients.

• Granules India Ltd.
  Offers reliable API solutions with a focus on quality and regulatory compliance, suitable for generic formulations of D IZAC.

3. European API Manufacturers

European companies often prioritize compliance with stricter regulatory environments, particularly for markets such as the U.S. and EU.

• Carbosynth Ltd.
  Based in the UK, Carbosynth supplies high-purity APIs, including benzodiazepines, supporting pharmaceutical R&D and commercial manufacturing with rigorous quality standards.

• Hikma Pharmaceuticals
  A major international supplier with manufacturing facilities in Europe, Hikma maintains compliance with GMP, providing bulk API for benzodiazepine derivatives.

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Supplier Qualification Criteria

When sourcing DIZECAP API, buyers should prioritize vendors that meet the following criteria:

• GMP Certification: Ensures manufacturing compliance with international quality standards.
• Regulatory Approvals: Certifications for markets such as the U.S. FDA, European EMA, or other relevant authorities.
• Quality Assurance: Certificates of Analysis (CoA), stability data, and purity certifications.
• Supply Chain Stability: Reliable delivery timelines, capacity for bulk orders, and contingency plans.
• Pricing and Lead Time: Competitive pricing aligned with manufacturing scale and lead-time flexibility.

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Regulatory and Compliance Considerations

DIZECAP being a benzodiazepine, is a controlled substance in many jurisdictions, including the U.S. (Schedule IV), EU, and other regions. Due diligence on vendor compliance with Controlled Substances Act (CSA) regulations and import/export controls is essential. Regulatory audits and supplier documentation must demonstrate adherence to the strictest standards to avoid legal or customs issues.

Emerging Trends and Outlook

• Supply Chain Diversification: To mitigate risks associated with geopolitical tensions or regulatory clampdowns, pharma companies are diversifying API sourcing to include multiple suppliers across different regions.
• GMP and Regulatory Stringency: As regulatory bodies tighten controls, API manufacturers are investing in better quality management systems, increasing transparency, and obtaining certifications, which enhances supplier credibility.
• Technological Advances: Increased automation and process standardization promote higher purity APIs with consistent batch quality, critical for benzodiazepine APIs.

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Conclusion: Ensuring Access to Quality API

The key to securing reliable DIZAC API supply lies in partnering with reputable, GMP-certified vendors with proven regulatory compliance. Given the sensitive nature of benzodiazepines, due diligence in vetting supplier certifications, quality control measures, and supply chain robustness remains vital. Companies must also monitor evolving regulatory frameworks to mitigate compliance risks and ensure uninterrupted production.

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Key Takeaways

• The primary sources of DIZECAP API are Chinese, Indian, and European manufacturers, with each region offering distinct advantages in compliance, cost, and supply reliability.
• Rigorous qualification of suppliers with GMP certifications and adherence to regulatory standards is imperative for legal and quality assurance.
• Supply chain diversification and continuous monitoring of regulatory changes can mitigate risks associated with controlled substance APIs.
• As global demand for benzodiazepine APIs persists, investment in supplier relationships and compliance infrastructure is essential to sustain supply and support market expansion.
• Emerging industry trends emphasize transparency, technological innovation, and regulatory alignment, which improve API quality and sourcing security.

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Frequently Asked Questions (FAQs)

Q1: What are the primary considerations when selecting an API supplier for DIZECAP?
A1: Critical factors include GMP certification, compliance with regulatory authorities, consistent quality, supply chain reliability, and competitive pricing.

Q2: Are there any regulatory restrictions on importing DIZECAP API?
A2: Yes, as a controlled substance, DIZECAP APIs are subject to strict regulations in many jurisdictions, requiring proper licensing, controlled substance registration, and adherence to import/export controls.

Q3: How can companies verify the quality of DIZECAP API from a supplier?
A3: Verification involves reviewing Certificates of Analysis, batch records, quality certifications, and conducting audits or third-party testing as needed.

Q4: What regions are considered the most reliable sources for DIZECAP APIs?
A4: Regions with established GMP standards and strict regulatory oversight, notably Europe, India, and China, are considered reliable sources.

Q5: How does geopolitical risk impact the sourcing of DIZECAP API?
A5: Geopolitical tensions can disrupt supply chains, leading companies to diversify sourcing across multiple regions, establish local manufacturing, or maintain inventory buffers.

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References

1. US Food and Drug Administration (FDA) API compliance guidelines.
2. European Medicines Agency (EMA) manufacturing standards.
3. Industry reports on API manufacturing and supplier certifications.