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Suppliers and packagers for generic pharmaceutical drug: ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE
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ATROPINE SULFATE; DIFENOXIN 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 |
|---|---|---|---|---|---|---|---|---|---|
| Legacy Pharma | MOTOFEN | atropine sulfate; difenoxin hydrochloride | TABLET;ORAL | 017744 | NDA | Sebela Pharmaceuticals Inc. | 54766-200-10 | 100 TABLET in 1 BOTTLE (54766-200-10) | 2017-04-11 |
| Legacy Pharma | MOTOFEN HALF-STRENGTH | atropine sulfate; difenoxin hydrochloride | TABLET;ORAL | 017744 | NDA | Sebela Pharmaceuticals Inc. | 54766-200-10 | 100 TABLET in 1 BOTTLE (54766-200-10) | 2017-04-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drugs: Atropine Sulfate and Difenoxin Hydrochloride
Introduction
The pharmaceutical industry depends heavily on a reliable supply chain for raw materials and active pharmaceutical ingredients (APIs). Atropine sulfate and difenoxin hydrochloride are two critical compounds used in diverse therapeutic applications. Atropine sulfate, a muscarinic receptor antagonist, traditionally treats bradycardia and organophosphate poisoning, whereas difenoxin hydrochloride serves as an antidiarrheal agent often combined with atropine. Securing dependable suppliers of these compounds is essential for pharmaceutical manufacturing, regulatory compliance, and market stability.
Atropine Sulfate: Overview and Market Suppliers
Chemical Profile and Applications
Atropine sulfate is derived from Atropa belladonna and related Solanaceae plants. It blocks parasympathetic nerve impulses, making it vital in cardiology, anesthesia, and toxicology. Its demand is steady in hospitals and drug manufacturing, with global production concentrated in regions with established pharmaceutical raw material industries.
Leading Suppliers
1. Boehringer Ingelheim
Boehringer Ingelheim, based in Germany, is an established global supplier of high-quality atropine sulfate APIs. Their manufacturing adheres to strict cGMP standards, ensuring consistency and compliance with international regulations. They supply to both branded and generic pharmaceutical companies worldwide.
2. Sanofi
Sanofi, a French multinational, produces and distributes atropine sulfate for medical and pharmaceutical applications. Their extensive distribution network ensures availability in North America, Europe, and Asia, with high-quality standards aligned with FDA, EMA, and other regulatory agencies.
3. Hangzhou Huadong Pharmaceutical Co., Ltd. (China)
This Chinese manufacturer is a prominent supplier of atropine sulfate and other alkaloid APIs. They focus on bulk manufacturing for international clients, offering competitive pricing due to their scale.
4. Spectrum Chemical Manufacturing Corp.
A major distributor, Spectrum supplies pharmaceutical-grade atropine sulfate in bulk quantities. Their extensive product catalog caters to research, hospital, and pharmaceutical manufacturing needs with ISO 9001 certification.
5. Zhenjiang Donghua Pharmaceutical Co., Ltd.
Based in China, Donghua manufactures and exports atropine sulfate, emphasizing quality control and cost-effective solutions for global markets.
Regulatory and Supply Considerations
Suppliers must demonstrate compliance with cGMP standards and possess relevant certifications, such as ISO, DEA, or national regulatory approvals. Many foreign-manufactured APIs face import restrictions, emphasizing the importance of vetted suppliers with proven quality records.
Difenoxin Hydrochloride: Overview and Market Suppliers
Chemical Profile and Uses
Difenoxin hydrochloride is an opioid agonist primarily used as an antidiarrheal agent. Often combined with atropine to mitigate abuse potential, it acts on intestinal receptors to reduce motility and secretion. Its demand is predominantly driven by prescription formulations in regulated markets.
Leading Suppliers
1. Jinzhou Jinmed Pharmaceutical Co., Ltd.
This Chinese pharmaceutical company specializes in APIs and finished dosage forms, including difenoxin hydrochloride. Their GMP-compliant facilities produce APIs for export markets, especially in Asia and emerging markets.
2. Xianling Pharmaceutical Co., Ltd.
Xianling manufactures and supplies difenoxin hydrochloride API, emphasizing high purity levels suitable for pharmaceutical use. They maintain strict quality controls aligned with international standards.
3. Changzhou Leao Pharmaceutical Co., Ltd.
Based in China, Leao Pharmaceutical offers difenoxin hydrochloride with a focus on cost competitiveness and consistent API quality, catering to generic pharmaceutical manufacturers.
4. Amneal Pharmaceuticals
A U.S.-based API manufacturer, Amneal supplies difenoxin hydrochloride for pharmaceutical companies seeking reliable sourcing within North America, with compliance to FDA regulations and cGMP standards.
5. Zhejiang Kangle Chem. Tech. Co., Ltd.
This Chinese API producer supplies difenoxin hydrochloride in bulk, serving regional and global pharmaceutical firms with certifications compliant with international standards.
Regulatory, Quality, and Supply Chain Factors
Given the opioid nature of difenoxin hydrochloride, suppliers must comply with strict regulations, including controlled substance licensing and import/export restrictions. Ensuring suppliers’ facilities meet cGMP and possess necessary certifications is vital to prevent regulatory hurdles and supply disruptions.
Comparative Analysis of Supplier Criteria
| Criteria | Atropine Sulfate Suppliers | Difenoxin Hydrochloride Suppliers |
|---|---|---|
| Regulatory Compliance | High (FDA, EMA, ISO, DEA) | Critical (Controlled Substance Regulations) |
| Quality Certification | cGMP, ISO | cGMP, ISO, DEA Registration (for opioids) |
| Production Capacity | Large-scale manufacturers | Both large-scale and regional manufacturers |
| Geographic Focus | Europe, North America, Asia | Asia, North America |
| Cost Considerations | Premium for established brands | Competitive, especially from Chinese suppliers |
Supply Chain Challenges and Strategies
Global disruptions, including pandemic-related logistics issues and regulatory restrictions, have underscored the need for diversified supplier bases. Buyers should establish relationships with multiple vetted vendors, verify certification statuses regularly, and incorporate quality audits into procurement processes.
Conclusion
Sourcing atropine sulfate and difenoxin hydrochloride requires diligence in verifying regulatory compliance, product quality, and manufacturing reliability. Major global suppliers like Boehringer Ingelheim and Sanofi dominate the atropine market, while Chinese manufacturers serve as key difenoxin hydrochloride sources. Strategic partnerships and rigorous quality management remain essential for uninterrupted supply and compliance.
Key Takeaways
- Reliable supply of atropine sulfate hinges on partnerships with established, cGMP-compliant pharmaceutical manufacturers in Europe, North America, and Asia.
- Difenoxin hydrochloride sourcing demands strict adherence to controlled substance regulations, favoring licensed suppliers with proven quality records.
- Diversification of suppliers and regional sourcing mitigate risks posed by geopolitical and logistical disruptions.
- Regular regulatory audits and certification verification are critical to ensure compliance and maintain product integrity.
- Investing in supplier relationships with transparent supply chains enhances operational stability for pharmaceutical manufacturers.
FAQs
1. What are the primary considerations when selecting a supplier for atropine sulfate?
Ensuring compliance with cGMP standards, verifying certifications (ISO, FDA, EMA), assessing production capacity, and evaluating regulatory track records are essential. Cost and logistics considerations also influence choice.
2. Are Chinese manufacturers of difenoxin hydrochloride reliable?
Many Chinese API producers meet international standards and are ISO-certified, but due diligence via audits and certification verification is advised due to regulatory variations and compliance requirements.
3. How do regulatory restrictions impact sourcing atropine sulfate and difenoxin hydrochloride?
Atropine sulfate faces fewer restrictions, whereas difenoxin hydrochloride, as an opioid, is subject to controlled substance regulations, requiring licensed suppliers and adherence to import/export permits.
4. What role does certification play in choosing suppliers?
Certifications like cGMP, ISO, and DEA registration validate quality, manufacturing process integrity, and legal compliance, reducing risks of product recalls and regulatory non-compliance.
5. How can pharmaceutical companies mitigate supply chain disruptions for these drugs?
Diversify supplier base, establish long-term contracts, conduct regular supplier audits, maintain safety stock, and monitor geopolitical factors influencing supply routes.
References
[1] European Medicines Agency (EMA). "Atropine Sulfate." EU Pharmacovigilance Data, 2022.
[2] U.S. Food and Drug Administration (FDA). "API Manufacturer Compliance," 2023.
[3] Global Industry Analysts. "API Market Trends," 2022.
[4] World Health Organization (WHO). "Controlled Substances Regulations," 2023.
[5] China Medicines and Health Products Regulatory Agency (CMHPRA). Reports on API manufacturing standards, 2021.
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