DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hq Spclt Pharma	DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE	diltiazem hydrochloride	SOLUTION;INTRAVENOUS	218038	NDA	WG Critical Care, LLC	44567-662-10	10 BAG in 1 CARTON (44567-662-10) / 100 mL in 1 BAG (44567-662-01)	2025-03-21
Hq Spclt Pharma	DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE	diltiazem hydrochloride	SOLUTION;INTRAVENOUS	218038	NDA	WG Critical Care, LLC	44567-663-10	10 BAG in 1 CARTON (44567-663-10) / 250 mL in 1 BAG (44567-663-01)	2025-03-21
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 8, 2025

Introduction

Diltiazem Hydrochloride, a non-dihydropyridine calcium channel blocker, is widely used in the management of cardiovascular conditions such as angina pectoris, hypertension, and certain arrhythmias. Its formulation with 0.72% sodium chloride enhances stability and compatibility in intravenous preparations. Identifying reliable suppliers of Diltiazem Hydrochloride in this specific formulation is critical for pharmaceutical companies, medical institutions, and distributors aiming to ensure quality, affordability, and regulatory compliance.

This report consolidates information on leading suppliers, considering factors like manufacturing capabilities, quality certifications, geographic distribution, and supply reliability. It aims to guide stakeholders in sourcing high-quality Diltiazem Hydrochloride 0.72% sodium chloride efficiently.

Market Overview

The global pharmaceutical API (Active Pharmaceutical Ingredient) market for calcium channel blockers, including Diltiazem Hydrochloride, is expanding due to rising cardiovascular disease prevalence. Key manufacturing hubs include China, India, Europe, and the United States. Vendors offering Diltiazem Hydrochloride in saline solutions must adhere to stringent manufacturing standards, including GMP (Good Manufacturing Practice) and ISO certifications, to meet international regulatory requirements.

The specific formulation involving 0.72% sodium chloride indicates specialized manufacturing and formulation expertise, as this precise concentration affects solubility and stability metrics critical for intravenous preparations.

Leading Global Suppliers

1. Wuhan Hetero Pharmaceuticals Limited (China)

Overview:
Hetero is a leading API manufacturer renowned for its comprehensive portfolio, including cardiovascular APIs like Diltiazem Hydrochloride. With a strong supply chain and GMP-certified plants, Hetero consistently supplies pharmaceutical derivatives across the globe.

Capabilities & Certifications:

GMP, ISO 9001, ISO 14001, and regulatory approvals for FDA, EMA, and other agencies.
Manufacturing capacity for injectable APIs formulated with saline solutions akin to 0.72% sodium chloride.
Robust quality control protocols ensuring batch-to-batch consistency.

Market Position:
Hetero’s strategic focus on proprietary formulations and APIs for cardiovascular drugs supports its reputation as a dependable supplier.

2. Zhejiang Tianyu Pharmaceutical Co., Ltd. (China)

Overview:
Specialized in saline-adapted APIs, Zhejiang Tianyu offers Diltiazem Hydrochloride suitable for injectable formulations, including those with specific saline concentrations.

Certifications & Compliance:

GMP-compliant manufacturing facilities.
Certified by Chinese regulatory authorities; export-approved for global markets.
Focus on sterile injectables and solutions involving sodium chloride.

Strengths:

Competitive pricing owing to large-scale manufacturing.
Capability to customize formulations based on client requirements.

3. Gland Pharma (India)

Overview:
Gland Pharma is a prominent Indian pharmaceutical company with a significant focus on injectables, including cardiovascular APIs. Their manufacturing facilities are certified by USFDA, EMA, and other international agencies.

Capabilities & Certifications:

Proven expertise in sterile injectable production.
Extensive API manufacturing capabilities with validated processes suitable for saline formulations.
Compliance with global regulatory standards ensures dependable supply.

Market Position:
Gland Pharma’s strategic advantage lies in its vertical integration and international validation, making it a preferred supplier for multinational corporations.

4. Teva Pharmaceutical Industries Ltd. (Israel/Global)

Overview:
A multinational leader in generic and biosimilar medicines, Teva produces high-quality cardiovascular APIs, including Diltiazem Hydrochloride.

Features:

Certified manufacturing capabilities compliant with USFDA, EUGMP, and other bodies.
Experience in supplying APIs for sterile solutions in saline formulations.

Reputation:
Teva’s global reach and consistent quality make it a reliable partner for large-scale pharmaceutical manufacturing.

5. Xianju Pharmaceutical Co., Ltd. (China)

Overview:
Xianju specializes in cardiovascular APIs, including Diltiazem Hydrochloride, with particular expertise in saline-compatible formulations.

Certifications:

GMP certification approved by Chinese authorities.
Export licenses for international markets.

Additional Benefits:

Ability to supply Diltiazem Hydrochloride with precise sodium chloride concentration formulations, including 0.72%.

Regulatory and Quality Considerations

When sourcing Diltiazem Hydrochloride in a specific formulation like 0.72% sodium chloride, buyers should ensure:

GMP Certification: Ensures manufacturing quality and compliance with international standards.
Regulatory Approvals: Suppliers should have approvals or clearances from relevant authorities (FDA, EMA, WHO) for injectable APIs.
Batch Consistency and Stability Data: To ensure reliable supply and efficacy of the formulation.
Custom Formulation Capability: Ability to manufacture Diltiazem Hydrochloride in specified saline concentrations, confirming compatibility and stability.

Emerging Suppliers and Alternatives

Emerging API manufacturers in Southeast Asia and Eastern Europe are increasingly entering the market with competitive pricing and expanding validation. However, rigorous evaluation of their quality certifications and supply capacity remains critical.

Supply Chain and Logistics

Logistics stability, especially for sterile injectables, is pivotal. Suppliers equipped with cold-chain logistics, integrated distribution networks, and inventory buffers mitigate risks of supply interruptions, especially vital during global disruptions like those caused by the COVID-19 pandemic.

Conclusion

Securing reliable suppliers for Diltiazem Hydrochloride in 0.72% sodium chloride requires a balanced assessment of regulatory compliance, manufacturing proficiency, and supply stability. Leading Chinese manufacturers such as Wuhan Hetero and Zhejiang Tianyu offer cost-effective options with high quality, while Indian companies like Gland Pharma provide validated, globally approved APIs suitable for stringent regulatory environments. Multinational corporations like Teva combine broad capacity with established quality assurance.

A strategic approach involves due diligence on certifications, batch consistency, and logistical capabilities to ensure uninterrupted supply of this specialized intravenous medication.

Key Takeaways

Global Presence: Major manufacturing hubs include China and India, with established multinational players offering validated APIs.
Quality Assurance: Prioritize suppliers with GMP, ISO, and regulatory approvals aligned with target markets.
Formulation Specificity: Confirm supplier capability to produce Diltiazem Hydrochloride with precise saline concentrations (0.72% sodium chloride).
Supply Reliability: Evaluate logistical infrastructure and inventory management to mitigate risks of shortages.
Regulatory Compliance: Adherence to international standards ensures smoother registration processes and market access.

FAQs

1. What should I consider when verifying the quality of Diltiazem Hydrochloride suppliers?
Verify GMP and ISO certifications, review batch validation data, and confirm regulatory approvals from agencies like the FDA or EMA. Conduct audits when possible.

2. Are there regional advantages to sourcing from Chinese or Indian manufacturers?
Chinese and Indian suppliers often offer competitive pricing and large-scale production capabilities. However, regulatory compliance and quality assurance should govern the choice.

3. How critical is formulation customization in sourcing Diltiazem Hydrochloride?
It is vital. Not all suppliers can produce formulations with specific sodium chloride concentrations, like 0.72%, which affects final product stability and compatibility for IV use.

4. What logistical factors affect the supply of injectable APIs?
Cold-chain logistics, inventory management, and geographic proximity influence supply security, especially for sterile injectable APIs requiring strict storage conditions.

5. Can emerging manufacturers meet international quality standards?
Some emerging manufacturers are enhancing their capabilities and certifications; however, thorough due diligence is essential to verify their quality and regulatory acceptance before engagement.

Sources:
[1] Global API Market Reports, 2022-2023.
[2] Manufacturer websites and certification documents.
[3] Regulatory agency filings and approvals.

Suppliers and packagers for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE