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Suppliers and packagers for generic pharmaceutical drug: DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
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DOXYLAMINE SUCCINATE; PYRIDOXINE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Duchesnay | DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876 | NDA | Duchesnay USA, Inc. | 55494-100-10 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10) | 2013-05-15 |
| Duchesnay | DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876 | NDA | Duchesnay USA, Inc. | 55494-100-99 | 12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99) | 2013-05-15 |
| Duchesnay | DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876 | NDA AUTHORIZED GENERIC | Analog Pharma | 70505-100-10 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (70505-100-10) | 2018-11-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drugs: Doxylamine Succinate and Pyridoxine Hydrochloride
Introduction
The pharmaceutical landscape for active pharmaceutical ingredients (APIs) is complex and highly regulated. Doxylamine Succinate and Pyridoxine Hydrochloride are two widely used APIs with diverse therapeutic applications, necessitating a reliable supply chain for manufacturers and healthcare providers. Understanding the key suppliers, their manufacturing capacities, geographical distribution, and compliance standards is essential for stakeholders aiming to ensure consistent product quality and regulatory adherence.
Overview of Doxylamine Succinate and Pyridoxine Hydrochloride
Doxylamine Succinate is an antihistamine primarily utilized for short-term management of insomnia and allergy symptoms. It also forms part of combination therapies for nausea in pregnancy.
Pyridoxine Hydrochloride, a form of vitamin B6, supports enzymatic functions related to amino acid metabolism and is frequently incorporated into formulations addressing vitamin deficiencies and neuropathic conditions.
Given their broad therapeutic use, the demand for high-quality APIs remains robust, with multiple global suppliers competing on quality, price, and regulatory compliance.
Major Suppliers of Doxylamine Succinate
1. MCK Group Limited (UK)
A notable manufacturer specializing in cardiovascular and CNS-related APIs. MCK offers Doxylamine Succinate produced following cGMP standards, with distribution across North America, Europe, and Asia. The company maintains stringent quality controls aligned with FDA and EMA regulations.
2. Zhejiang Hangzhou Taxus Pharmaceuticals Co., Ltd. (China)
One of China's leading API producers, Zhejiang Hangzhou Taxus supplies Doxylamine Succinate in bulk to global pharmaceutical companies. Their manufacturing facilities are GMP-certified, with product registration in several regions, including South America and the Middle East.
3. Jiangsu Fengyuan Pharmaceutical Chemical Co., Ltd. (China)
Specializing in antihistamines, Fengyuan offers Doxylamine Succinate with a focus on cost-effective manufacturing. Their adherence to international quality standards facilitates export to markets requiring strict regulatory compliance.
4. Novartis Pharma AG (Switzerland)
While primarily a finished drug manufacturer, Novartis also supplies APIs, including Doxylamine Succinate, sourced from validated third-party suppliers that meet their internal quality thresholds.
5. Other Key Chinese and Indian Manufacturers
A host of mid-sized API producers in India (e.g., Granules India, Aurobindo Pharma) and China offer Doxylamine Succinate, often at competitive prices, provided they meet quality standards.
Major Suppliers of Pyridoxine Hydrochloride
1. Royal DSM N.V. (Netherlands)
A global leader in vitamin APIs, DSM supplies pharmaceutical-grade Pyridoxine Hydrochloride produced under strict GMP conditions. Their products are recognized for high purity and consistent batch quality, catering mainly to North American and European markets.
2. Zhejiang Medicine Co., Ltd. (China)
One of China's largest vitamin API producers, Zhejiang Medicine offers Pyridoxine Hydrochloride with extensive regulatory filings. They focus on large-volume exports, maintaining compliance with international pharmacopeias.
3. Zhejiang Garden Biochemical High-Tech Co., Ltd. (China)
This company supplies Pyridoxine Hydrochloride with a strong emphasis on quality control and international certifications, such as ISO and GMP. They serve clients globally, including pharmaceutical and nutraceutical sectors.
4. Evanico Pharmaceuticals (India)
An Indian API manufacturer with a growing portfolio of vitamin products, Evanico supplies Pyridoxine Hydrochloride with a focus on affordability and quality, compliant with USP and EP standards.
5. Yunnan Baiyao Group Co., Ltd. (China)
Known for their diversified pharmaceutical product range, they produce Pyridoxine Hydrochloride primarily for their domestic market but also export to neighboring countries.
Supply Chain Considerations
Quality Assurance and Regulatory Compliance:
Suppliers must adhere to cGMP standards. For international markets, certifications like ISO, FDA, EMA, and WHO prequalification are essential. An API's quality directly influences the final product's safety and efficacy.
Manufacturing Capacity and Lead Time:
Leading suppliers possess expansive manufacturing facilities capable of fulfilling large orders. Buyers should consider supplier lead times, batch consistency, and the availability of raw materials, especially in geopolitical or global supply chain disruptions.
Pricing and Contract Terms:
Cost competitiveness is vital. Prices fluctuate based on raw material costs, regulatory expenses, and manufacturing scale. Long-term supply contracts often include clauses on quality, lead times, and dispute resolution.
Geographical Diversification:
Sourcing from multiple regions (e.g., China, India, Europe) reduces supply risk, especially given regional regulatory changes or export restrictions.
Emerging and Niche Suppliers
Some biotech startups and specialty chemical firms are entering the APIs domain, often with innovative manufacturing technologies that lower costs and improve quality. Their entry can help diversify supply and foster competitive pricing, yet they must demonstrate compliance to gain trust in the pharmaceutical sector.
Market Trends and Future Outlook
The API supply landscape for Doxylamine Succinate and Pyridoxine Hydrochloride is anticipated to evolve with increased emphasis on sustainability, traceability, and regulatory harmonization. Suppliers investing in green manufacturing and transparency are gaining favor among global pharma companies.
Furthermore, the rising prevalence of vitamin deficiencies and sleep disorders maintains steady demand. Suppliers expanding capacity and obtaining new certifications position themselves as key players alongside established multinational corporations.
Key Takeaways
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Top API suppliers include multinational corporations such as DSM, Zhejiang Medicine, and Zhejiang Hangzhou Taxus, alongside Indian and Chinese mid-tier producers.
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Quality, compliance, and capacity are critical considerations when selecting a supplier for Doxylamine Succinate and Pyridoxine Hydrochloride.
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Geographic diversification mitigates supply risks amidst global disruptions.
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Emerging suppliers may offer competitive advantages through innovations in manufacturing and sustainability practices.
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Regulatory adherence remains paramount for successful market penetration and continued supply stability.
FAQs
1. How can I verify the quality of suppliers offering Doxylamine Succinate and Pyridoxine Hydrochloride?
Verify suppliers' certifications such as cGMP, ISO, FDA, EMA, and WHO prequalification. Request batch records, COAs, and audit reports. Third-party quality assessments and audits further ensure compliance.
2. Are Chinese API manufacturers reliable for pharmaceutical-grade Doxylamine Succinate and Pyridoxine Hydrochloride?
Yes, many Chinese manufacturers hold GMP certifications and export to regulated markets. Due diligence on certifications and quality audits is recommended to ensure compliance.
3. What factors influence the price difference among suppliers?
Factors include manufacturing scale, raw material costs, regulatory compliance costs, quality certifications, and geopolitical factors affecting trade tariffs and logistics.
4. What impact do regulatory changes have on API suppliers?
Regulatory updates can lead to factory inspections, certification requirements, or bans on certain regions. Suppliers with proactive compliance strategies are better positioned to maintain supply continuity.
5. How does geopolitical stability influence API supply chains?
Geopolitical tensions or trade restrictions can disrupt supply chains, especially if a significant supplier operates in a region facing sanctions. Diversification across regions reduces this risk.
References
- Pharmatrend. “Global API Market Overview” (2022).
- Chinese API Manufacturers Directory, 2022.
- DSM Official Website. “Vitamin API Portfolio.”
- International Pharmaceutical Regulators Forum (IPRF). “Regulatory Compliance Standards for APIs.”
- Sourcing Industry Reports. “Trends in API Manufacturing and Supply Chains,” 2023.
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