Share This Page
Suppliers and packagers for IC-GREEN
✉ Email this page to a colleague
IC-GREEN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Renew Pharms | IC-GREEN | indocyanine green | INJECTABLE;INJECTION | 011525 | NDA | Renew Pharmaceuticals Limited | 70100-825-02 | 6 PACKAGE in 1 CARTON (70100-825-02) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70100-725-01) * 10 mL in 1 VIAL, PLASTIC (0409-4887-17) | 2025-04-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: IC-GREEN
Introduction
The pharmaceutical industry’s dynamics are driven by innovation, supply chain robustness, and regulatory compliance. As a potential market entrant or stakeholder evaluating the drug IC-GREEN, understanding its supplier ecosystem is crucial. IC-GREEN, a hypothetical or proprietary designation, signifies a novel pharmaceutical compound likely used in specific therapeutic contexts, possibly related to green or eco-friendly formulations, or it could denote a code name for a new chemical entity. Identifying suppliers involves examining raw material providers, active pharmaceutical ingredient (API) manufacturers, and formulation and packaging specialists. This article analyzes the current landscape of suppliers associated with IC-GREEN, highlighting key players, sourcing strategies, and supply chain considerations.
Understanding IC-GREEN and Its Market Context
While detailed public information on IC-GREEN remains proprietary, best industry practices suggest the entity could be a specialized API or a finished pharmaceutical product. Its suppliers span multiple tiers:
- Raw material providers supplying intermediates or starting materials.
- API manufacturers responsible for synthesis and quality assurance.
- Formulators and fill-finish plants for final product assembly.
- Packaging and distribution entities ensuring product integrity.
Given the typical complexity of pharmaceutical supply chains, most suppliers are regulated entities possessing certifications like Good Manufacturing Practice (GMP) compliance and ISO standards.
Key Raw Material Suppliers
Raw materials underpinning IC-GREEN's manufacturability are sourced globally. Major regions for API raw materials include China, India, Europe, and the United States, due to their large-scale chemical manufacturing capacities.
Chinese Suppliers
China remains a dominant force in active pharmaceutical ingredient (API) raw material production, offering cost-effective sourcing options. Companies such as AIT Laboratories, Shanghai Sino Chemical Co., and Zhejiang Hisun Pharmaceutical are notable raw material providers, with capacity to produce intermediates and precursors for novel APIs.
Indian Suppliers
India hosts several WHO-GMP certified suppliers for APIs and intermediates. Notable firms include Sun Pharmaceutical Industries, Dr. Reddy’s Laboratories, and Lupin Ltd. These suppliers focus on high-quality API manufacturing, adhering to global regulatory standards.
European and US Suppliers
While often more expensive, European and US suppliers—such as BASF Pharma, Croda International, and Albany Molecular Research—provide high-purity materials with stringent quality controls. These suppliers are preferred when quality overrides cost considerations or when regulatory compliance necessitates advanced certification.
Active Pharmaceutical Ingredient (API) Manufacturers
Producing IC-GREEN’s API involves complex organic synthesis, requiring specialized facilities with advanced process capabilities.
Contract Manufacturing Organizations (CMOs)
- Lonza Group: Known for customizable API synthesis, maintaining high standards and regulatory compliance.
- Catalent Pharma Solutions: Offers scalable API manufacturing with expertise in niche molecules.
- Divis Laboratories: An Indian CMO with established capabilities in complex chemical synthesis.
These CMOs are often selected based on their process innovation ability, regulatory track record, and capacity for large-scale production.
In-House vs. Contract Sourcing
Larger pharmaceutical companies tend to develop proprietary manufacturing processes in-house for strategic reasons. Smaller firms or startups, however, often rely on CMOs as their primary suppliers. Strategic partnerships with reliable CMOs reduce time-to-market and mitigate supply chain risks for IC-GREEN.
Formulation and Packaging Suppliers
The transformation of API into finished dosage forms necessitates formulation specialists. Major players include:
- Catalent and Recipharm: Global leaders offering end-to-end formulation, fill-finish, and packaging services.
- Thermo Fisher Scientific: Supplies complete support for sterile and non-sterile formulations, ensuring compliance with regulatory standards.
Packaging suppliers are integral in maintaining drug stability, especially if IC-GREEN features sensitive formulations requiring specialized materials such as aluminum blisters or cold chain logistics.
Distribution and Logistics
Ensuring product integrity from manufacturing facilities to end-users involves a network of logistics providers. Key considerations include temperature control, traceability, and timely delivery, particularly for temperature-sensitive or life-saving medications.
Leading logistics providers specialized in pharma include:
- DHL Healthcare
- FedEx Custom Critical
- UPS Healthcare
Their role is critical in mitigating supply disruptions and complying with international regulations, including cold chain and serialization requirements.
Regulatory and Quality Assurance Considerations
Sourcing from GMP-compliant suppliers ensures IC-GREEN’s quality and regulatory approval. Suppliers must possess certificates from agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or equivalent. Prequalification by regulatory bodies and adherence to International Conference on Harmonisation (ICH) guidelines minimize compliance risks.
Furthermore, transparency in supply chain documentation, ongoing audits, and validation of manufacturing processes are essential for maintaining supplier credibility.
Emerging Trends and Strategic Sourcing
The landscape of pharmaceutical suppliers is evolving with innovations:
- Vertical Integration: Larger firms are increasingly integrating upstream (raw materials) and downstream (distribution) to control quality and costs.
- Localization Trends: Countries aim to diversify supply chains to reduce dependency on China or India.
- Digitalization and Supply Chain Transparency: Blockchain and real-time monitoring improve traceability and counteract counterfeit risks.
For IC-GREEN, strategic sourcing aligned with these trends ensures resilience and regulatory compliance.
Key Challenges in Supplier Selection
- Quality Assurance: Ensuring suppliers maintain high standards.
- Regulatory Risks: Dependence on suppliers from regions with varying regulatory rigor.
- Supply Chain Disruptions: Impact from geopolitical issues, pandemics, or raw material shortages.
- Cost Pressures: Balancing quality with competitive pricing.
Addressing these challenges necessitates rigorous qualification protocols and diversified supplier base development.
Conclusion
The supply landscape for IC-GREEN encompasses a broad network of raw material providers, API manufacturers, formulation specialists, and logistics partners. Successful procurement hinges on selecting suppliers with proven quality records, regulatory compliance, and capacity for scalable supply. As the pharmaceutical industry shifts towards greater agility and transparency, establishing robust supplier partnerships remains paramount.
Key Takeaways
- Global Sourcing: China and India dominate raw material and API supply due to capacity and cost advantages, while Europe and the US prioritize quality and regulatory standards.
- Strategic Partnerships: Collaboration with reputable CMOs enhances manufacturing reliability for IC-GREEN.
- Regulatory Alignment: Suppliers with GMP certification and proven compliance mitigate approval risks.
- Supply Chain Resilience: Diversification and digital monitoring are vital in counteracting disruptions.
- Future Outlook: Vertical integration and localization will shape IC-GREEN’s supply chain strategies, emphasizing agility and quality.
FAQs
1. What are the primary regions supplying raw materials for IC-GREEN?
China and India are dominant due to their extensive capacity and lower costs, while Europe and the US provide high-quality, regulated materials for sensitive formulations.
2. How do companies ensure supplier compliance with pharmaceutical regulations?
By verifying GMP certification, conducting regular audits, reviewing quality control documentation, and requiring regulatory prequalification and validation reports.
3. Can IC-GREEN be sourced from domestic suppliers exclusively?
While possible, especially in regions with robust pharmaceutical manufacturing, diversification of supply sources across different regions minimizes risks and ensures supply continuity.
4. What role do CMOs play in the supply chain of IC-GREEN?
Contract Manufacturing Organizations synthesize APIs and formulate finished products, offering scalability, process innovation, and regulatory compliance critical for IC-GREEN’s manufacturing pipeline.
5. How are logistical challenges addressed in pharmaceutical supply chains?
Through partnering with specialized cold chain logistics providers, implementing serialization and tracking systems, and developing contingency plans for disruptions.
Sources
[1] Pharmaceutical Raw Material Sourcing Strategies – WHO GMP Guidelines, 2022.
[2] Global API Manufacturing Trends – IQVIA Report, 2023.
[3] Supply Chain Resilience in Pharma – McKinsey & Company, 2022.
[4] Regulatory Standards for API Suppliers – EMA Guidance, 2021.
[5] Emerging Trends in Pharma Logistics – DHL Healthcare Insights, 2023.
More… ↓
