Share This Page
Suppliers and packagers for DARANIDE
✉ Email this page to a colleague
DARANIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Xeris | DARANIDE | dichlorphenamide | TABLET;ORAL | 011366 | NDA | Xeris Pharmaceuticals, Inc. | 72065-001-01 | 100 TABLET in 1 BOTTLE (72065-001-01) | 2021-12-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DARANIDE
Introduction
DARANIDE (chlorpheniramine maleate, phenylephrine hydrochloride, and ephedrine sulfate) is a combination medication primarily used to treat symptoms associated with allergic conditions, cold, and respiratory issues. Its formulation leverages antihistamine and decongestant properties to provide symptomatic relief. As with many over-the-counter and prescription pharmaceuticals, identifying reliable suppliers is critical for pharmaceutical companies, healthcare providers, and distributors to ensure quality, compliance, and uninterrupted supply chains.
This article examines the global landscape of suppliers involved in the manufacturing and distribution of DARANIDE, emphasizing sourcing options, key manufacturers, regulatory considerations, and market dynamics.
Understanding the Composition and Manufacturing of DARANIDE
DARANIDE combines three active pharmaceutical ingredients (APIs):
- Chlorpheniramine maleate: An antihistamine that alleviates allergy symptoms.
- Phenylephrine hydrochloride: A decongestant restoring nasal airflow.
- Ephedrine sulfate: A bronchodilator and decongestant.
The manufacturing process involves sourcing each API from specialized chemical producers, ensuring they meet Good Manufacturing Practice (GMP) standards, followed by formulation and packaging by pharmaceutical manufacturers.
Global API Suppliers for DARANIDE Components
The supply chain for DARANIDE hinges on the availability of high-quality APIs. The primary suppliers of each component are often located in key regions with established pharmaceutical manufacturing hubs.
1. Chlorpheniramine Maleate
Chlorpheniramine maleate is widely manufactured by numerous API suppliers, notably:
- Hikma Pharmaceuticals (Jordan): A prominent generic API producer with a comprehensive portfolio.
- Mundipharma, India: Specializes in antihistamine APIs and intermediates.
- Sino Bioway (China): A leader in the production of antihistamine APIs, including chlorpheniramine, operating under strict GMP standards.
- Jubilant Life Sciences (India): Produces various pharmaceutical intermediates and APIs, including antihistamines.
2. Phenylephrine Hydrochloride
Key suppliers include:
- Otsuka Pharmaceutical (Japan): Innovator and supplier investing heavily in decongestant APIs.
- Shandong Xinhua Pharmaceutical (China): Large-scale producer of phenylephrine derivatives, known for cost-effective manufacturing.
- Taj Pharmaceuticals (India): Noted for its high-quality phenylephrine API supply.
- Moezin (Korea): Offers phenylephrine hydrochloride to global markets.
3. Ephedrine Sulfate
Although ephedrine has regulatory restrictions in some regions, its API remains available through:
- Jubilant Life Sciences (India): One of the largest global suppliers.
- Piramal Enterprises (India): A significant producer with compliance to GMP and international standards.
- Amneal Pharmaceuticals (USA): Supplies ephedrine for medicinal use, adhering to stringent regulations.
- Shandong Xinhua Pharmaceutical (China): Major manufacturer with extensive export capabilities.
Pharmaceutical Formulation and Finished Product Suppliers
While API suppliers are crucial, the production of DARANIDE as a finished dosage form involves contract manufacturing organizations (CMOs) and pharmaceutical companies specializing in formulation.
-
Pharmaceutical giants in India and China frequently serve as primary formulators, including:
- Sun Pharma (India): Known for aerosols, tablets, and syrups.
- Dr. Reddy’s Laboratories (India): Produces a wide range of combination medications.
- Hikma Pharmaceuticals (Jordan): Active in formulations for global markets.
- China-based companies such as North China Pharmaceutical Group Corporation: Often involved in generic formulations.
These firms often source APIs from above-mentioned suppliers, complying with international quality standards.
Regulatory and Quality Considerations
- GMP Compliance: Ensures APIs and formulations meet safety and efficacy standards. Suppliers accredited by agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or equivalent bodies are preferred.
- Certifications: Certificates of Analysis (CoA), Drug Master Files (DMF), and batch certifications are critical for compliance.
- Regional Regulatory Constraints: Ephedrine’s legal status varies globally. Suppliers must adhere to local restrictions, such as the Combat Methamphetamine Epidemic Act (CMEA) in the U.S.
Market Dynamics Influencing Supplier Selection
- Price and Cost Efficiency: Suppliers from India and China dominate owing to manufacturing economies.
- Supply Chain Stability: Long-term relationships and diversified sourcing mitigate risks of shortages.
- Regulatory Track Record: Suppliers with proven compliance histories reduce regulatory hurdles.
- Innovative Capacity: Suppliers investing in quality improvements and process innovations are preferred.
Emerging Trends and Future Outlook
- Continued Expansion in Asia: Indian and Chinese manufacturers dominate the API landscape for components of DARANIDE.
- Shift Towards Quality and Compliance: Regulatory tightening globally emphasizes high-quality API sourcing.
- Supply Chain Resilience: Post-pandemic disruptions prompt pharmaceutical companies to diversify suppliers and explore local manufacturing options.
- Sustainability and Green Chemistry Initiatives: Suppliers adopting eco-friendly practices may have competitive advantages.
Conclusion
The supply ecosystem for DARANIDE comprises global API manufacturers, with Indian and Chinese companies leading in terms of capacity and cost-efficiency. Key API suppliers include Jubilant Life Sciences, Shandong Xinhua Pharmaceutical, and Piramal Enterprises. The formulation is predominantly handled by regional pharmaceutical firms with established GMP compliance.
Ensuring a robust supply chain entails selecting suppliers with proven quality standards, regulatory compliance, and stable production capacities. Future trends point toward intensified regulatory scrutiny, diversification of supply sources, and sustainability initiatives. Stakeholders must continuously monitor supplier performance, regulatory updates, and market developments to sustain reliable access to DARANIDE.
Key Takeaways
- Reliable suppliers of DARANIDE’s APIs are primarily located in India, China, and Japan, with prominent players establishing a global presence.
- API quality, GMP compliance, and regulatory approvals are critical factors in supplier selection.
- The market is evolving towards increased regulatory oversight, emphasizing quality over cost.
- Diversification of supplier base reduces risk and enhances supply chain resilience.
- Emerging trends emphasize sustainable manufacturing practices, influencing future supplier choices.
FAQs
1. What are the primary regions producing APIs for DARANIDE?
India and China dominate the manufacturing of APIs like chlorpheniramine, phenylephrine, and ephedrine due to their large-scale, cost-effective production capabilities.
2. How does regulatory compliance impact API supplier selection?
Suppliers must adhere to GMP standards and hold necessary certifications (e.g., FDA, EMA) to ensure API quality and facilitate regulatory approval of finished products.
3. Are there regional restrictions on the supply of ephedrine sulfate?
Yes. Ephedrine is subject to strict regulations in many regions due to its potential use in methamphetamine synthesis, necessitating careful supplier screening and compliance.
4. How do supply chain disruptions affect DARANIDE availability?
Disruptions in API production or logistics, especially in regions with concentrated suppliers, can lead to shortages. Diversifying sourcing is vital for stability.
5. What future trends will influence suppliers of DARANIDE?
An increasing focus on regulatory compliance, quality, sustainability, and supply chain resilience will shape the selection and development of API suppliers in the coming years.
References
[1] US FDA Database. (2022). API Manufacturer Information.
[2] IMS Health. Pharmaceutical Market Reports. (2021). Global API Production Trends.
[3] European Medicines Agency. Certification and Compliance Standards. (2022).
[4] Industry Reports. Indian and Chinese API Manufacturers' Market Share. (2022).
[5] World Health Organization. Guidelines on Good Manufacturing Practices. (2020).
More… ↓
