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Suppliers and packagers for DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)
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DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hikma | DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) | dicyclomine hydrochloride | INJECTABLE;INJECTION | 040465 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6173-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6173-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0641-6173-01) | 2015-12-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Pharmaceutical Drug: Dicyclomine Hydrochloride (Preservative-Free)
Introduction
Dicyclomine hydrochloride is a well-established antispasmodic medication primarily prescribed for gastrointestinal conditions such as irritable bowel syndrome (IBS). Its efficacy depends on high-quality manufacturing processes, including the use of preservative-free formulations to minimize adverse reactions. This article examines the leading suppliers of preservative-free dicyclomine hydrochloride, analyzing their market position, quality standards, and supply chain reliability—critical factors for pharmaceutical companies seeking consistent, high-grade supplies.
Overview of Dicyclomine Hydrochloride
Dicyclomine hydrochloride is a muscarinic receptor antagonist that alleviates intestinal spasms and reduces abdominal pain. The pharmaceutical industry requires procurement from reputable suppliers capable of delivering preservative-free formulations to meet strict regulatory and patient safety standards. Preservative-free options are preferred for specific patient populations, including those with sensitivities or allergies.
Major Suppliers of Preservative-Free Dicyclomine Hydrochloride
1. Aarti Drugs Ltd.
Profile and Market Position:
An Indian pharmaceutical manufacturer, Aarti Drugs offers high-quality active pharmaceutical ingredients (APIs), including dicyclomine hydrochloride. The company adheres to cGMP (current Good Manufacturing Practices) and complies with international quality standards, including WHO-GMP certification.
Product Offerings and Quality Certifications:
Aarti provides preservative-free formulations, emphasizing purity and stability. The company holds GMP, ISO 9001, and other quality certifications, which are crucial for global distribution.
Supply Chain and Reliability:
Aarti has a robust global supply network, serving clients across North America, Europe, and Asia. Their production capacity and compliance with regulatory standards make them a reliable supplier for pharmaceutical companies.
2. Jubilant Cadista Pharmaceuticals Inc.
Profile and Market Position:
An established U.S.-based manufacturer, Jubilant Cadista supplies a comprehensive portfolio of APIs. Their focus includes producing preservative-free APIs to meet the needs of the modern pharmaceutical industry.
Product Quality Standards:
Jubilant adheres to FDA cGMP standards, with extensive documentation supporting the purity and stability of their dicyclomine hydrochloride API. Their formulations are available preservative-free, suitable for sensitive patient populations.
Supply Chain and Reliability:
With manufacturing facilities in the USA, Jubilant boasts stringent quality control, quick turnaround times, and supply consistency, making them a preferred partner for major pharmaceutical firms operating globally.
3. Hetero Labs Ltd.
Profile and Market Position:
Hetero is a leading Indian pharmaceutical company specializing in the production of APIs, including preservative-free dicyclomine hydrochloride. Their focus on quality and affordability renders them competitive on the global stage.
Quality and Certification:
Hetero maintains WHO-GMP and ISO certifications, with an emphasis on high purity and batch-to-batch consistency. Their APIs comply with international pharmacopeial standards.
Supply Capabilities:
Supported by extensive R&D and large-scale manufacturing, Hetero supplies to numerous countries, ensuring reliable procurement for global markets. Their preservative-free APIs are suitable for both generic and branded formulations.
4. Sandoz (Novartis Division)
Profile and Market Position:
Sandoz, a division of Novartis, offers generic APIs including preservative-free dicyclomine hydrochloride. Their global presence and reputation for quality position them as prominent suppliers.
Certifications and Standards:
Sandoz adheres to cGMP, ICH, and other regulatory standards, ensuring high-quality APIs. Their preservative-free formulations meet international safety and efficacy criteria.
Supply Chain Reliability:
With manufacturing sites worldwide, Sandoz guarantees stability in supply and stringent quality assurance, essential for the pharmaceutical industry's continuous production needs.
5. Zhejiang Hisun Pharmaceutical Co., Ltd.
Profile and Market Position:
A Chinese API manufacturer, Hisun supplies preservative-free dicyclomine hydrochloride with an increasing footprint in the global market. Their focus is on cost-effective, high-quality APIs.
Quality Standards:
Hisun holds GMP, ISO, and other certifications, with rigorous quality control measures to ensure API purity and stability.
Market Reach and Reliability:
Their expanding global distribution network offers a dependable supply chain, supported by aggressive R&D investments to meet evolving regulatory standards.
Emerging Suppliers and Market Trends
While established companies dominate the API space for preservative-free dicyclomine hydrochloride, emerging suppliers from India, China, and Eastern Europe are entering the market, leveraging advancements in process engineering and cost competitiveness. Notable trends include:
- Emphasis on compliance with international regulatory standards (FDA, EMA, WHO).
- Increasing certification of preservative-free formulations to meet pharmaceutical safety requirements.
- Growing focus on supply chain transparency and sustainable manufacturing practices.
Quality Considerations for Procurement
For pharmaceutical companies, selecting suppliers for preservative-free dicyclomine hydrochloride requires assessing:
- Regulatory certifications: cGMP, ISO, WHO-GMP.
- API purity and stability data.
- Batch consistency and quality control protocols.
- Supply chain resilience and scalability.
- Lead times and delivery reliability.
Thorough due diligence and supplier audits are essential to ensure compliance with local and international regulatory frameworks.
Conclusion
The market for preservative-free dicyclomine hydrochloride features a mix of established global players, including Indian, American, and Chinese manufacturers. Leading suppliers such as Aarti Drugs, Jubilant Cadista, Hetero Labs, Sandoz, and Zhejiang Hisun provide high-quality APIs that meet rigorous regulatory standards. Pharmaceutical companies should prioritize suppliers demonstrating strong quality assurance, certification compliance, and supply chain robustness to secure a reliable source of preservative-free dicyclomine hydrochloride.
Key Takeaways
- Global supplier landscape combines Indian, American, and Chinese firms, with established certifications supporting quality.
- Regulatory compliance (GMP, ISO, WHO-GMP) is critical in vendor selection.
- Preservative-free formulations are increasingly in demand for sensitive patient populations.
- Supply chain reliability ensures uninterrupted production, vital in high-demand medications.
- Due diligence including audits and quality validation ensures procurement meets industry standards.
FAQs
1. What are the benefits of sourcing preservative-free dicyclomine hydrochloride?
Preservative-free APIs minimize allergic reactions, enhance patient safety, and are preferred for sensitive populations, aligning with regulatory and safety standards.
2. Which certifications should I look for in a supplier?
Certifications such as cGMP, ISO 9001, WHO-GMP, and regulatory approvals from FDA or EMA indicate manufacturing quality and compliance.
3. Are there differences in pricing among suppliers?
Pricing varies based on manufacturing scale, quality standards, and region. Indian manufacturers typically offer cost advantages, while American or European suppliers emphasize stringent quality assurance.
4. How do I verify the quality of an API supplier?
Conduct supplier audits, review batch records, verify certification authenticity, and request stability and purity data for their APIs.
5. Can the suppliers meet large-volume demands?
Most top-tier suppliers have extensive manufacturing capacity and can manage high-volume orders, but lead times should be confirmed during procurement planning.
References
[1] World Health Organization. WHO-GMP Certification Standards.
[2] U.S. Food and Drug Administration. cGMP Regulations.
[3] Indian Pharmaceutical Alliance. API Manufacturing Standards Review.
[4] European Medicines Agency. Quality Standards for APIs.
[5] Industry Reports on API Market Trends, 2022.
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