ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	SOLUTION;ORAL	087708	ANDA	Hikma Pharmaceuticals USA Inc.	0054-3194-46	1 BOTTLE in 1 CARTON (0054-3194-46) / 60 mL in 1 BOTTLE	1982-05-03
Ani Pharms	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	086727	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-594-30	30 TABLET in 1 BOTTLE (43353-594-30)	2017-06-20
Ani Pharms	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	086727	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-594-53	60 TABLET in 1 BOTTLE (43353-594-53)	2017-06-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

The global pharmaceutical landscape depends heavily on a complex network of manufacturers and suppliers for active pharmaceutical ingredients (APIs). Atropine sulfate and diphenoxylate hydrochloride, vital components in various therapeutic formulations, have diverse applications ranging from anesthesia to antidiarrheal treatments. Securing reliable sources for these chemicals is crucial for pharmaceutical companies, regulatory bodies, and healthcare providers to ensure consistent drug supply and compliance with regulatory standards.

Overview of Atropine Sulfate and Diphenoxylate Hydrochloride

Atropine sulfate is a tropane alkaloid derived from plants like Atropa belladonna (deadly nightshade) and Datura stramonium. It acts as a competitive antagonist of the parasympathetic neurotransmitter acetylcholine, making it essential in ophthalmology, anesthesiology, and antispasmodic agents.

Diphenoxylate hydrochloride is an opioid antidiarrheal agent, often combined with atropine in formulations (e.g., Lomotil), to inhibit gut motility and reduce diarrhea. Its pharmaceutical synthesis involves complex chemical processes, and sourcing high-quality API is paramount for patient safety and regulatory compliance.

Major Suppliers for Atropine Sulfate

1. Global API Manufacturers

The primary suppliers for atropine sulfate are established pharmaceutical raw material producers, particularly in countries with robust chemical manufacturing infrastructure such as India, China, and Europe.

Sun Pharmaceutical Industries Ltd. (India): One of the world’s leading pharmaceutical companies, Sun Pharma manufactures a wide range of APIs, including atropine sulfate. Their products adhere to international quality standards and are supplied globally.
Siegfried AG (Switzerland): Renowned for synthesizing complex APIs, Siegfried supplies atropine sulfate for bulk pharmaceutical production, emphasizing high purity and compliance with cGMP standards.
Zhejiang Hisun Pharmaceutical Co., Ltd. (China): A major Chinese API producer that supplies atropine sulfate to international markets, with manufacturing facilities compliant with international quality regulations.
Hovione (Portugal): An API manufacturer, known for complex molecule synthesis, including atropine sulfate, with a focus on quality control and environmental sustainability.

2. Domestic Suppliers and Distributors

Many regional pharmaceutical distributors in North America and Europe source atropine sulfate from international suppliers, often adhering to regulatory standards such as USP or EP specifications. Notable distributors include:

Fagron and Baxter—distributing bulk APIs and excipients compliant with their respective regional standards.
APICs and Contract Manufacturing Organizations (CMOs)—who source from established API manufacturers to meet supply chain demands.

Suppliers for Diphenoxylate Hydrochloride

1. Prominent Global Manufacturers

Diphenoxylate hydrochloride is less commonly manufactured by smaller suppliers due to its complex synthesis and strict regulatory controls. Major manufacturers include:

Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Also produces diphenoxylate hydrochloride, ensuring consistent supply to international markets.
Hubei Wushi Pharmaceutical Co., Ltd. (China): Offers diphenoxylate hydrochloride APIs, emphasizing quality and compliance with pharmacopeial standards.
Shandong Luwei Pharmaceutical Co. (China): Supplies pharmaceutical-grade diphenoxylate hydrochloride, with exports to North America and Europe.
Domestic US and European Suppliers: Some U.S. and European companies, such as American Regent or Mikro+Polymer, source from Chinese manufacturers or produce via in-house synthesis under strict cGMP regulations.

2. Regulatory Compliance and Quality Considerations

Manufacturers supplying diphenoxylate hydrochloride must adhere to stringent analytical, pharmacopoeial, and cGMP standards owing to its opioid nature. Regulatory approvals are essential, especially in markets like the US (FDA-approved) and Europe (EMA regulations).

Regional Market Dynamics and Regulatory Considerations

India and China as Major API Hubs

India and China dominate the global API manufacturing sector, accounting for over 60% of the world's raw material supply, largely due to cost advantages, large-scale manufacturing capacity, and evolving quality standards. Suppliers from these regions often provide APIs at competitive prices, but buyers should rigorously assess compliance with international quality standards such as USP, EP, or JP.

European and North American Suppliers

European and North American companies tend to focus on high-quality, high-purity APIs with advanced quality assurance protocols. These regions have stricter regulatory oversight, which often translates into higher costs but guarantees product consistency and safety.

Supply Chain Challenges and Risk Management

Sourcing atropine sulfate and diphenoxylate hydrochloride poses specific challenges:

Regulatory Variability: Different countries have varying standards, necessitating comprehensive qualification and validation processes for suppliers.
Intellectual Property and Patent Status: Both APIs are off-patent, but manufacturing processes are proprietary to some manufacturers, impacting licensing and sourcing agreements.
Quality Assurance: Ensuring API purity, pharmacopoeial compliance, and batch-to-batch consistency is critical to avoid regulatory rejections and ensure drug efficacy.
Supply Chain Disruptions: Political instability, trade restrictions, and global health crises (e.g., COVID-19 pandemic) can impact the supply of APIs. Multiple sourcing and inventory management are essential strategies.

Emerging Trends and Future Outlook

Vertical Integration: Some pharmaceutical companies are investing in in-house API manufacturing to secure supply chains for low-margin APIs like atropine sulfate and diphenoxylate hydrochloride.
Regulatory Harmonization: Ongoing global efforts aim to harmonize API standards, reducing barriers to international sourcing.
Sustainability Initiatives: Suppliers adopting environmentally sustainable manufacturing practices are gaining favor, aligning with global pharma ESG initiatives.
Biotechnological Alternatives: R&D efforts continue into alternative synthetic pathways and biotechnological production methods to improve yield and reduce costs.

Key Takeaways

The primary global suppliers for atropine sulfate are companies in India, China, Switzerland, and Portugal, with strict quality standards underpinning their supply chains.
Diphenoxylate hydrochloride manufacturers predominantly operate within China, with quality and regulatory compliance as critical differentiators.
Regional sourcing strategies must consider regulatory approval, quality assurance, and supply chain resilience.
Diversification of suppliers and proactive qualification processes mitigate the risk of supply disruptions.
The evolving landscape underscores the importance of compliance with international standards for APIs, emphasizing quality, traceability, and sustainable manufacturing practices.

FAQs

1. Are there genuine US-based suppliers for atropine sulfate and diphenoxylate hydrochloride?
Yes. While many APIs are manufactured abroad, US-based suppliers such as American Regent or sterile pharmaceutical companies may directly produce or import high-quality APIs, ensuring regulatory compliance tailored to markets like the US.

2. What regulatory standards should suppliers for these APIs meet?
Suppliers should comply with pharmacopoeial standards such as USP, EP, or JP, and adhere to cGMP regulations set by agencies like the FDA or EMA to ensure product quality and safety.

3. How can buyers verify the quality of APIs from international suppliers?
Buyers should conduct comprehensive vendor qualification including audit reports, batch testing, analytical dossiers, and certifications guaranteeing batch-to-batch consistency and purity.

4. What are the main risks associated with sourcing these APIs from Asia?
Risks include variable quality levels, regulatory discrepancies, intellectual property concerns, and supply chain disruptions. Due diligence and supplier qualification are essential to mitigate these risks.

5. Is there a trend towards local manufacturing of these APIs?
Yes. Increased investment in regional manufacturing facilities aims to reduce dependence on overseas APIs, improve supply chain security, and meet regional regulatory requirements.

Sources

[1] Pharmaceutical Provider Directories, 2023.
[2] World Health Organization (WHO) Global Pharmaceutical Market Reports, 2022.
[3] US FDA API Manufacturer Directory, 2023.
[4] European Medicines Agency (EMA) Approved API Suppliers, 2023.
[5] Industry Reports on API Manufacturing and Supply Chain Trends, 2022.

Suppliers and packagers for generic pharmaceutical drug: ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE