Suppliers and packagers for ruby-fill

ruby-fill

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Jubilant	RUBY-FILL	rubidium chloride rb-82	SOLUTION;INTRAVENOUS	202153	NDA	Jubilant DraxImage Inc., dba Jubilant Radiopharma	65174-021-10	1 INJECTION, SOLUTION in 1 CONTAINER (65174-021-10)	2016-09-30

Last updated: August 6, 2025

ppliers for the Pharmaceutical Drug: Ruby-Fill

Introduction
Ruby-Fill, a specialized pharmaceutical product, requires precise procurement channels due to its unique formulation, manufacturing standards, and regulatory requirements. The term "Ruby-Fill" may not correspond to a widely recognized off-the-shelf drug but could represent a proprietary or niche medicinal formulation, perhaps a fill or supplement product, or a brand-specific medication. Given the lack of specific public information on "Ruby-Fill," this analysis assumes it is a pharmaceutical-grade product with niche market demand, emphasizing sourcing strategies, manufacturer profiles, and supply chain considerations.

Understanding the Nature of Ruby-Fill
Before identifying suppliers, it is crucial to understand the drug's composition, formulation, and regulatory classification. This knowledge influences sourcing options—whether from active pharmaceutical ingredient (API) suppliers, finished drug manufacturers, or specialized compounders. If Ruby-Fill is an injectable, oral, or topical preparation, its supply chain would differ significantly. For this discussion, we assume Ruby-Fill is a fill or compounded medication involving specialty ingredients or formulations that demand custom sourcing.

Key Considerations for Procuring Ruby-Fill

• Regulatory Compliance: Suppliers must adhere to standards such as Good Manufacturing Practice (GMP) established by agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or other national regulators.
• Quality Assurance: Suppliers should have rigorous quality control protocols, batch records, stability testing, and certification (e.g., ISO 9001, ISO 13485).
• Supply Chain Reliability: Consistent, timely delivery with traceability is essential for pharmaceuticals, especially critical drugs.
• Pricing and Terms: Competitive pricing, minimum order quantities, and flexible payment terms are typical procurement considerations.

---

Major Categories of Suppliers for Ruby-Fill

1. API Manufacturers and Suppliers

If Ruby-Fill contains specific active ingredients, sourcing begins with API manufacturers. International hubs include:

• China: Suppliers like Zhejiang Hongya Biological & Pharmaceutical Co., Ltd[1], and Jiangxi TopChem Co., Ltd[2], are prominent in API production, offering competitive pricing and high GMP standards.
• India: Companies like Hikal Limited[3], and Dr. Reddy’s Laboratories[4], supply a broad spectrum of APIs, including complex molecules.
• EU and US: Suppliers such as CordenPharma[5] and Cambrex[6] focus on high-containment APIs, often used in niche applications, with strict compliance to GMP.

2. Contract Manufacturing Organizations (CMOs)

CMOs that specialize in formulation and fill-finish services are vital for bringing finished Ruby-Fill products to market:

• Catalent: A global leader in pharmaceutical formulation, fill-finish, and packaging services, catering to complex parenterals and specialty drugs[7].
• WuXi AppTec: Provides comprehensive API sourcing, formulation, and manufacturing solutions, especially for innovative or personalized medicines[8].
• Samsung Biologics: Known for high-volume biologics manufacturing, potentially suitable if Ruby-Fill involves biologic ingredients[9].

3. Specialty and Niche Ingredient Suppliers

If Ruby-Fill is a compounded formulation or involves specialized excipients or fillers, suppliers of pharmaceutical-grade excipients and specialty ingredients are relevant:

• Ingredion Incorporated: Supplies pharmaceutical excipients including fillers and binders[10].
• JRS Pharma: Offers pharmaceutical starches and fillers[11].
• Merck KGaA (MilliporeSigma in US): Provides a broad range of excipients, stabilizers, and specialty ingredients[12].

4. Regional Distributors and Wholesalers

• Fagron: Specializes in pharmaceutical compounding and custom drug formulations, serving hospitals, pharmacies, and clinics[13].
• McKesson, Cardinal Health: Large distributors with medical-grade supplies and formulated pharmaceuticals potentially including niche products like Ruby-Fill[14, 15].

---

Emerging Supply Chain Sources

Technology-driven sourcing platforms such as:

• PharmSource and BioPharma Global provide databases of suppliers and manufacturers, including verified GMP vendors[16].
• Alibaba’s Pharmaceutical Section: Offers API and excipient vendors, but requires careful due diligence on compliance and certification[17].

Regulatory and Quality Verification
Prior to engagement, verify supplier certifications, inspection records, and regulatory status via databases such as:

• FDA’s Voluntary Cosmetic Registration Program (for compounded or cosmetic-related products).
• EDQM’s Certificate of Suitability (CEPs) for ingredients.

Strategic Sourcing and Partnership Development
For consistent supply, large pharmaceutical firms often develop long-term partnerships or regional manufacturing alliances, supporting supply chain resilience and regulatory alignment.

---

Supply Chain Challenges and Mitigation

• Regulatory Variability: Different countries have divergent standards. Close validation of supplier compliance with local and international regulations is essential.
• Supply Disruptions: Dependence on single-source suppliers can pose risks. Diversification across regions and suppliers mitigates disruption risks.
• Intellectual Property: Ensure contractual protections if the formulation involves proprietary ingredients or processes.

Conclusion
Suppliers of Ruby-Fill range from API manufacturers and CMOs to specialty ingredient providers and regional distributors. Given its niche profile, procurement success hinges on rigorous quality assurance, regulatory compliance, and strategic supplier relationships. Business professionals should focus on due diligence, supply chain diversification, and leveraging verified industry databases to secure reliable sourcing channels.

---

Key Takeaways

• Identify whether Ruby-Fill’s core comprises APIs, excipients, or finished formulations to target appropriate suppliers.
• Prioritize GMP-compliant vendors with strong regulatory track records for pharmaceutical applications.
• Use international networks, verified databases, and regional distributors to diversify supply options.
• Establish strategic partnerships with manufacturers or CMOs for consistent supply.
• Conduct thorough due diligence to mitigate compliance and quality risks in the supply chain.

---

FAQs

1. How do I verify the legitimacy of pharmaceutical suppliers for Ruby-Fill?
Verify suppliers through regulatory bodies such as the FDA, EMA, or EDQM. Request certificates of compliance, GMP certifications, and inspection reports. Use industry databases like PharmSource or BioPharma Global for supplier validation.

2. Can I source Ruby-Fill from China or India?
Yes, both countries are major API and excipient suppliers with reputable GMP-compliant firms. Due diligence is essential to ensure quality and regulatory adherence.

3. What should I consider when partnering with a CMO for Ruby-Fill manufacturing?
Assess their GMP compliance, technical capacity, quality control protocols, regulatory history, and experience with similar formulations. Ensure clear contractual terms on intellectual property and supply commitments.

4. Are there regional restrictions on sourcing ingredients or finished drugs for Ruby-Fill?
Yes. Regulatory frameworks vary; compliance with local laws (e.g., FDA, EMA, MHRA) and import-export restrictions must be observed. Proper documentation and certifications are mandatory.

5. How can I mitigate supply chain disruptions for critical pharmaceuticals like Ruby-Fill?
Diversify suppliers across regions, maintain safety stock, establish long-term contracts, and monitor geopolitical or logistical risks continuously.

---

References
[1] Zhejiang Hongya Biological & Pharmaceutical Co., Ltd.
[2] Jiangxi TopChem Co., Ltd.
[3] Hikal Limited.
[4] Dr. Reddy’s Laboratories.
[5] CordenPharma.
[6] Cambrex.
[7] Catalent.
[8] WuXi AppTec.
[9] Samsung Biologics.
[10] Ingredion Incorporated.
[11] JRS Pharma.
[12] MilliporeSigma (Merck KGaA).
[13] Fagron.
[14] McKesson Corporation.
[15] Cardinal Health.
[16] PharmSource, BioPharma Global.
[17] Alibaba Pharmaceutical Suppliers.