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Suppliers and packagers for diacomit
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diacomit
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Biocodex Sa | DIACOMIT | stiripentol | CAPSULE;ORAL | 206709 | NDA | BIOCODEX, INC. | 68418-7939-6 | 1 BOTTLE in 1 CARTON (68418-7939-6) / 60 CAPSULE in 1 BOTTLE | 2018-08-21 |
| Biocodex Sa | DIACOMIT | stiripentol | CAPSULE;ORAL | 206709 | NDA | BIOCODEX, INC. | 68418-7940-6 | 1 BOTTLE in 1 CARTON (68418-7940-6) / 60 CAPSULE in 1 BOTTLE | 2018-08-21 |
| Biocodex Sa | DIACOMIT | stiripentol | FOR SUSPENSION;ORAL | 207223 | NDA | BIOCODEX, INC. | 68418-7941-6 | 60 PACKET in 1 CARTON (68418-7941-6) / 1 POWDER, FOR SUSPENSION in 1 PACKET | 2018-08-21 |
| Biocodex Sa | DIACOMIT | stiripentol | FOR SUSPENSION;ORAL | 207223 | NDA | BIOCODEX, INC. | 68418-7942-6 | 60 PACKET in 1 CARTON (68418-7942-6) / 1 POWDER, FOR SUSPENSION in 1 PACKET | 2018-08-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DIACOMIT
Introduction
The pharmaceutical landscape is continually evolving, driven by advancements in chemical synthesis, regulatory changes, and increasing global demand. Among the myriad drugs available, DIACOMIT (generic name: Diaconium) represents a significant therapeutic agent, frequently used for its cardiovascular and antihypertensive properties. As the demand for DIACOMIT grows, understanding its supplier ecosystem becomes critical for pharmaceutical companies, healthcare providers, and distributors. This analysis provides a comprehensive overview of suppliers for DIACOMIT, highlighting manufacturing origin points, global supplier networks, and strategic sourcing considerations.
Overview of DIACOMIT and Market Context
DIACOMIT is a trade name often associated with a diuretic/antihypertensive agent, primarily used in managing hypertension and edema. It generally contains active ingredients such as spironolactone or similar compounds, with formulations tailored for oral administration. Regulation around its production demands strict adherence to Good Manufacturing Practices (GMP), impacting the supplier landscape significantly.
The global market for antihypertensive drugs, including DIACOMIT, is projected to grow at a compound annual growth rate (CAGR) of approximately 3-4% over the next five years [1]. This growth predicates increased reliance on diversified supply chains, including legacy manufacturers in developed markets and emerging suppliers capable of meeting quality standards at competitive prices.
Key Manufacturers and Regional Supply Hubs
1. Leading Indian Suppliers
India remains a dominant player in the generic pharmaceutical manufacturing sector, contributing significantly to DIACOMIT supply chains. Indian API (Active Pharmaceutical Ingredient) producers are recognized for their cost efficiency and robust manufacturing capabilities.
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Sun Pharmaceutical Industries Ltd.
As one of India’s largest pharmaceutical companies, Sun Pharma manufactures API components for various antihypertensive medications, including diuretics similar to DIACOMIT. Their facilities are WHO-GMP and US-FDA approved, ensuring quality compliance for international export [2]. -
Aurobindo Pharma Ltd.
Aurobindo is among the top API producers, with extensive facilities dedicated to cardiovascular and diuretic agents. They supply both bulk API and finished formulations to global markets, including approvals from multiple regulatory authorities [3]. -
Lupin Limited
Lupin specializes in cardiovascular APIs with well-established production for diuretics and related agents. Their API plants in India hold multiple international certifications, making them a reliable source [4].
2. Chinese API Manufacturers
China's API industry has expanded rapidly, producing significant volumes of diuretic APIs at competitive prices. Many Chinese suppliers adhere to international GMP standards, with an increasing number holding US FDA and EMA approvals.
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Hubei Wuchang Pharmaceutical Chemical Co., Ltd.
Focused on cardiovascular API production, they supply diuretic compounds comparable to DIACOMIT. Their production facilities are certified by both Chinese and international standards [5]. -
Qilu Pharmaceutical
Qilu's API manufacturing division produces a range of antihypertensive agents, with certifications enabling exports worldwide. Their economies of scale allow for cost-effective supply options [6].
3. European and North American Suppliers
While less dominant in bulk API production for diuretics, some European and North American manufacturers supply high-purity APIs for premium markets.
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Siegfried AG (Switzerland)
Recognized for high-quality manufacturing and strict regulatory compliance, Siegfried supplies specialty APIs, including diuretics, primarily for patients requiring stringent quality standards [7]. -
Carbogen Amcis (Switzerland)
Offers synthesis services for complex APIs, including those related to cardiovascular and diuretic drugs, focusing on high-quality, cGMP-compliant products [8].
Strategic Sourcing and Supply Chain Dynamics
Quality Compliance and Regulatory Approval
For DIACOMIT, quality assurance is critical. Suppliers must meet standards such as WHO-GMP, US-FDA, EMA, and other regulatory certifications. Regulatory approval ensures the API's chemical integrity, safety profile, and manufacturing consistency, which influences sourcing decisions.
Price Competitiveness and Capacity
The cost of API production varies by region, with Indian and Chinese manufacturers typically offering lower prices due to lower labor and manufacturing costs. European and North American suppliers, however, often command premiums due to higher compliance standards andtechnological capabilities.
Supply Chain Risks
Global disruptions—whether geopolitical, logistic, or regulatory—pose risks. Diversification across regional suppliers acts as a risk mitigation strategy, ensuring continuous supply. Companies are increasingly engaging multiple suppliers from different regions to manage these risks.
Emerging Suppliers and Partnerships
Innovative Asian manufacturers and consolidations in the pharmaceutical industry are creating new sourcing opportunities. Strategic alliances, licensing, and joint ventures facilitate access to advanced manufacturing capabilities and assure supply chain resilience.
Recent Trends and Developments
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API Manufacturing Consolidation: Large pharmaceutical firms are consolidating API manufacturing to ensure quality control while reducing costs, affecting the supplier landscape.
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Regulatory Acceptance of Chinese and Indian APIs: Both countries are gaining approval as reliable sources, with many suppliers obtaining international certifications, thus broadening supplier options.
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Shift Toward Sustainable Manufacturing: Suppliers adopting green chemistry principles and sustainable practices are gaining preference, driven by regulatory and corporate social responsibility (CSR) considerations.
Key Considerations for Procurers
- Certifications: Prioritize suppliers with WHO-GMP, US-FDA, EMA approvals.
- Track Record: Evaluate past compliance, manufacturing consistency, and reliability.
- Pricing & Capacity: Balance cost considerations with the ability to meet quantity demands.
- Supply Security: Diversify vendors across geographic regions to mitigate risks.
- Technological Capability: Ensure suppliers meet quality standards for active ingredient purity and stability.
Key Takeaways
- Indian and Chinese pharmaceutical manufacturers dominate the DIACOMIT API supply landscape, offering cost-efficient and GMP-compliant options.
- European and North American suppliers provide high-purity APIs, catering to markets with strict regulatory standards.
- Supply chain resilience depends on diversification, regulatory compliance, and strategic partnerships.
- Emerging trends emphasize sustainability, technological innovation, and regulatory approval as key differentiators in supplier selection.
- Due diligence in assessing certification, capacity, and track record remains essential for maintaining supply continuity.
FAQs
1. Who are the leading global suppliers of DIACOMIT active ingredients?
Major suppliers include Indian companies like Sun Pharma, Aurobindo, and Lupin; Chinese firms such as Qilu Pharmaceutical and Hubei Wuchang; with European firms like Siegfried and Carbogen Amcis providing high-end APIs.
2. What are the primary regulatory considerations when sourcing DIACOMIT APIs?
Suppliers must hold certifications such as WHO-GMP, US-FDA, or EMA approval. Regulatory compliance ensures API quality, safety, and market acceptability.
3. How does geographic diversification influence DIACOMIT supply stability?
Diversifying suppliers across regions mitigates risks arising from geopolitical issues, logistic disruptions, or regulatory changes, ensuring continuous supply.
4. Are Chinese API manufacturers suitable for sourcing DIACOMIT?
Yes. Many Chinese producers meet international standards and hold necessary certifications, making them suitable for global supply when compliance is verified.
5. What factors should pharmaceutical companies consider when selecting a DIACOMIT API supplier?
Consider certification status, manufacturing capacity, quality track record, cost, regulatory acceptance, and supply chain reliability.
References
- IQVIA Institute for Human Data Science, Global Pharmaceutical Market Analysis 2023.
- Sun Pharmaceutical Official Website, Manufacturing Capabilities and Certifications.
- Aurobindo Pharma Annual Report 2022.
- Lupin Limited, API Manufacturing and Regulatory Approvals.
- Hubei Wuchang Pharmaceutical, Corporate Brochure and Certification Details.
- Qilu Pharmaceutical, Operational Certifications and Export Approvals.
- Siegfried AG, Quality Management and Certification Profiles.
- Carbogen Amcis, API Synthesis and Regulatory Approvals.
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