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Suppliers and packagers for generic pharmaceutical drug: CLOMIPRAMINE HYDROCHLORIDE
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CLOMIPRAMINE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Specgx Llc | ANAFRANIL | clomipramine hydrochloride | CAPSULE;ORAL | 019906 | NDA | SpecGx LLC | 0406-8806-01 | 100 CAPSULE in 1 BOTTLE (0406-8806-01) | 2015-06-01 |
| Specgx Llc | ANAFRANIL | clomipramine hydrochloride | CAPSULE;ORAL | 019906 | NDA | SpecGx LLC | 0406-8807-01 | 100 CAPSULE in 1 BOTTLE (0406-8807-01) | 2015-06-01 |
| Specgx Llc | ANAFRANIL | clomipramine hydrochloride | CAPSULE;ORAL | 019906 | NDA | SpecGx LLC | 0406-8808-01 | 100 CAPSULE in 1 BOTTLE (0406-8808-01) | 2015-06-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CLOMIPRAMINE HYDROCHLORIDE
Introduction
Clomipramine Hydrochloride, a tricyclic antidepressant (TCA), is primarily indicated for treating obsessive-compulsive disorder (OCD) and depression. As a critical pharmaceutical ingredient, its sourcing involves multiple reputable suppliers specializing in high-purity active pharmaceutical ingredients (APIs). Reliable, regulatory-compliant suppliers are crucial for pharmaceutical companies seeking to ensure drug efficacy, safety, and consistent manufacturing standards. This article provides a comprehensive overview of key suppliers for Clomipramine Hydrochloride, guiding stakeholders in procurement, quality assurance, and strategic sourcing.
Manufacturers and Suppliers of Clomipramine Hydrochloride
Global Producers of Clomipramine Hydrochloride
The primary suppliers of Clomipramine Hydrochloride are established API manufacturers, predominantly based in Asia, Europe, and North America. These entities facilitate global distribution channels serving pharmaceutical companies worldwide. Notably, suppliers differ in their capacity, certification standards, and customization capabilities, affecting their suitability for various procurement needs.
Major Suppliers and Exporters
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Sun Pharmaceutical Industries Ltd. (India)
- Overview: As one of India's largest pharmaceutical companies, Sun Pharma offers a broad portfolio of APIs, including Clomipramine Hydrochloride.
- Capabilities: Certified with WHO-GMP and ISO standards; extensive export network.
- Strengths: High production capacity, rigorous quality control, competitive pricing.
- Regulatory Status: Compliant with USFDA, EDQM, and other global standards.
-
Hetero Labs Limited (India)
- Overview: Recognized for high-quality APIs, Hetero supplies Clomipramine Hydrochloride to international markets.
- Manufacturing: Equipped with state-of-the-art facilities adhering to cGMP.
- Certifications: USFDA, EU GMP, and ISO certifications assure regulatory compliance.
-
Zhejiang Xianju Pharmaceutical Co., Ltd. (China)
- Overview: A prominent Chinese API manufacturer with a focus on psychiatric and neurological drugs.
- Capacity & Quality: Capable of large-scale production with stringent quality assurance measures.
- Certifications: ISO9001, ISO14001, and cGMP compliance.
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Shimi Pharma (India)
- Overview: A specialized supplier for neuropsychiatric APIs, including Clomipramine Hydrochloride.
- Features: Emphasis on quality, affordability, and flexibility in formulation specifications.
- Certifications: ISO standards, and some facilities comply with USFDA requirements.
-
LGM Pharma (USA)
- Overview: A US-based distributor specializing in high-quality APIs, including Clomipramine Hydrochloride.
- Advantages: Quality-controlled supply chain, comprehensive documentation, regulatory support.
- Approach: Focus on sourcing from cGMP-certified manufacturers to ensure compliance.
Selection Criteria for Clomipramine Hydrochloride Suppliers
When choosing a supplier, pharmaceutical companies consider several critical factors:
- Regulatory Compliance: Ensuring suppliers hold certifications such as USFDA, EMA, EDQM, or WHO prequalification.
- Quality Assurance: Robust quality control processes, batch consistency, and stability data.
- Production Capacity: Ability to meet demand volume and delivery timelines.
- Pricing: Competitive costing aligned with quality standards.
- Supply Chain Security: Reliable logistics, inventory management, and contingency plans.
- Technical Support: Assistance with stability data, formulation development, and regulatory documentation.
Emerging Markets and New Entrants
As demand for psychiatric medications grows globally, emerging manufacturers in countries like South Korea, Vietnam, and Turkey are entering the market with certified APIs. These suppliers often focus on cost-effective solutions, though buyers must verify quality compliance.
Regulatory Considerations
Suppliers compliant with international standards simplify approval processes. Notable certifications include:
- USFDA: Essential for markets in the United States.
- EUGMP (European Good Manufacturing Practices): Facilitates EU market entry.
- ISO 9001/ISO 14001: Indicates quality and environmental management.
- WHO Prequalification: Engages suppliers for low- and middle-income country access.
Challenges in Supplier Selection
- Quality Variability: Differing manufacturing standards can impact API consistency.
- Regulatory Barriers: Non-compliant suppliers pose risks for market approval.
- Supply Chain Disruptions: Global geopolitical issues or pandemics may affect delivery schedules.
- Pricing Fluctuations: Currency fluctuations and raw material availability influence costs.
Due Diligence and Vendor Verification
Effective due diligence involves auditing manufacturing facilities, reviewing quality documents, and verifying certifications. Engaging third-party verifiers or consultancy services can mitigate procurement risks. Establishing long-term partnerships with reputable suppliers promotes supply stability and quality assurance.
Future Trends in API Supply for Clomipramine Hydrochloride
Advances in continuous manufacturing, process automation, and quality by design (QbD) are likely to improve API quality and supply security. Additionally, increasing regulatory emphasis on transparent supply chains supports the growth of certified and inspected suppliers.
Key Takeaways
- Trusted suppliers for Clomipramine Hydrochloride include Sun Pharma, Hetero Labs, Zhejiang Xianju, and LGM Pharma, among others.
- Regulatory compliance and quality standards are paramount for procurement success.
- Comprehensive supplier evaluation encompassing capacity, certifications, and supply chain robustness ensures drug manufacturing reliability.
- The emergence of regional suppliers in Asia provides cost-effective options, but quality verification remains critical.
- Ongoing innovation in manufacturing processes enhances API quality, stability, and supply security.
FAQs
Q1: How can pharmaceutical companies verify the quality of Clomipramine Hydrochloride supplied by vendors?
A: Companies should request certifications (e.g., USFDA, EMA, WHO), batch analytical data, stability reports, and conduct on-site audits or third-party inspections to verify quality.
Q2: Are there alternative suppliers to major Indian and Chinese manufacturers for Clomipramine Hydrochloride?
A: Yes. Emerging manufacturers globally, including firms in South Korea, Turkey, and Eastern Europe, are developing compliant APIs, though due diligence is essential to verify quality and regulatory standing.
Q3: What are the primary regulatory hurdles in importing Clomipramine Hydrochloride API?
A: Regulatory barriers include obtaining GMP certifications, aligning with country-specific registration procedures, ensuring traceability, and meeting import/export documentation requirements.
Q4: How does geopolitical instability affect API supply chains for Clomipramine Hydrochloride?
A: Geopolitical tensions can disrupt manufacturing, export policies, and logistics, leading to delays or shortages. Diversifying suppliers and maintaining safety stock mitigate such risks.
Q5: What future developments could influence the supply landscape of Clomipramine Hydrochloride?
A: Innovations in continuous manufacturing, regulatory pathways for biosimilars, and global focus on transparency will shape supply dynamics, potentially improving quality, cost, and availability.
Sources
[1] PharmaCompass. API manufacturers directory.
[2] U.S. Food & Drug Administration. Establishment Registration & Drug Listing.
[3] EDQM. Certificate of Suitability (CEP) for APIs.
[4] International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). Global API Supply Chains.
[5] GlobalTrade. Regulations on pharmaceutical imports and certifications.
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