Suppliers and packagers for ojjaara

ojjaara

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873	NDA	GlaxoSmithKline LLC	81864-101-30	30 TABLET in 1 BOTTLE (81864-101-30)	2023-09-15
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873	NDA	GlaxoSmithKline LLC	81864-102-30	30 TABLET in 1 BOTTLE (81864-102-30)	2023-09-15
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873	NDA	GlaxoSmithKline LLC	81864-103-30	30 TABLET in 1 BOTTLE (81864-103-30)	2023-09-15

Last updated: July 27, 2025

ppliers for the Pharmaceutical Drug: OJJAARA

Introduction
In the highly competitive and regulated pharmaceutical industry, securing reliable suppliers for a novel or existing drug like OJJAARA is critical for ensuring product availability, quality, and compliance. OJJAARA’s supplier landscape can influence manufacturing continuity, regulatory adherence, and ultimately, market success. This analysis provides a comprehensive overview of potential suppliers for OJJAARA, including key considerations for partnership, quality assurance, regulatory compliance, and supply chain resilience.

Overview of OJJAARA
OJJAARA is a therapeutically targeted pharmaceutical compound currently in the advanced stages of development or approved for specific indications. While specific details about OJJAARA, including its chemical composition or therapeutic class, are proprietary or unpublished in this context, its procurement and supply chain strategies are universal in scope for pharmaceuticals of similar complexity.

Key Criteria for OJJAARA Suppliers
Selecting appropriate suppliers for OJJAARA hinges on several criteria:

• GMP Compliance: Suppliers must adhere to Good Manufacturing Practices (GMP) prescribed by regulatory agencies such as the FDA, EMA, or equivalents.
• Quality and Purity: High-quality raw materials and active pharmaceutical ingredients (APIs) with verified purity levels.
• Regulatory Approval and Documentation: Valid certifications, batch records, and compliance reports.
• Supply Chain Security: Reliable delivery schedules, contingency plans, and capacity for scale-up.
• Cost and Lead Times: Competitive pricing balanced with operational timelines.
• Innovation and R&D Support: Potential for collaboration in process optimization or formulation improvements.

Types of Suppliers for OJJAARA

1. API Manufacturers
   The core component of OJJAARA’s supply chain starts with the API manufacturer. These entities synthesize or isolate the active ingredient essential for drug efficacy. Leading global API producers typically include:

• Lonza (Switzerland): Renowned for high-quality APIs and custom manufacturing.
• Catalent (USA): Known for comprehensive development and manufacturing services.
• WuXi AppTec (China): A major player with a broad API portfolio and global reach.
• Fujifilm Toyama Chemical (Japan): Specialists in complex APIs with stringent quality protocols.

2. Excipient Suppliers
   Depending on OJJAARA’s formulation, excipient suppliers play an integral role. Key excipients might include binders, fillers, stabilizers, or preservatives. Leading excipient providers include:

• Raymond Limited (India): Known for pharmaceutical excipients.
• DuPont Nutrition & Health (USA): Provides a wide range of pharmaceutically accepted excipients.
• BASF (Germany): Supplies various pharmaceutical-grade excipients across the globe.

3. Packaging and Labeling Suppliers
   For ensuring compliance with tamper-evidence, stability, and regulatory labeling, specialized packaging suppliers are essential. Notable providers include:

• Gerresheimer (Germany): Glass and plastic vials and ampoules.
• West Pharmaceutical Services (USA): Blister packs, prefilled syringes.

4. Contract Manufacturers (CMOs) and Contract Development and Manufacturing Organizations (CDMOs)
   In some cases, manufacturing is outsourced to CMOs/CDMOs with specialized expertise. These organizations may handle bulk production, packaging, or distribution. Examples are:

• Samsung Biologics (South Korea): Large-scale biologics and chemical manufacturing.
• Boehringer Ingelheim (Germany): For complex small molecule production.
• Thermo Fisher Scientific (USA): For specialty formulation and packaging.

Emerging and Strategic Suppliers
Given global supply chain vulnerabilities, diversification of suppliers is prudent. This includes developing relationships with regional suppliers to mitigate risks from geopolitical or pandemic disruptions.

Regulatory and Quality Considerations
Suppliers for OJJAARA must demonstrate endorsement by stringent regulatory agencies. Quality audits, documentation, and continuous validation ensure compliance. Suppliers with SAE (Supply Acceptance Evaluation) status or recognized certifications (ISO 9001/13485, GDP) foster confidence.

Supply Chain Resilience and Risk Management
In recent years, the importance of a robust supply chain has risen. Strategies include dual sourcing, inventory buffers, and early supplier engagement. For OJJAARA, integrating suppliers with proven track records for timely delivery and quality underpins operational success.

Strategic Partnerships and Raw Material Sourcing
Proactive engagement with suppliers often extends beyond transactional relationships to strategic partnerships. These can involve joint process improvements, technology transfer, or early-stage formulation collaboration, enhancing flexibility and reducing lead times.

Conclusion
The supplier network for OJJAARA encompasses a complex ecosystem critical to its success. Prioritizing quality, compliance, and resilience will facilitate uninterrupted supply flow. As the pharmaceutical landscape evolves, active supplier management and diversification remain paramount for delivering this medication efficiently worldwide.

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Key Takeaways

• Selecting GMP-compliant API manufacturers, excipient providers, and CMOs is essential for ensuring product integrity.
• A diversified supplier base mitigates risks associated with geopolitical, regulatory, or supply disruptions.
• Regular audits, certifications, and compliance documentation underpin supplier credibility.
• Strategic supplier engagement can drive process innovation and improve time-to-market.
• Building resilient supply chains protects against unforeseen disruptions and sustains market access.

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FAQs

1. How are API suppliers for OJJAARA selected?
Suppliers are chosen based on GMP compliance, quality standards, regulatory approval history, manufacturing capacity, and reliability in delivery. Vendor audits and review of certification documents are standard procedures.

2. What role do excipient suppliers play in OJJAARA’s supply chain?
Excipient suppliers provide inert ingredients essential for drug formulation. Selecting suppliers with pharmacopeial-grade excipients ensures product stability and regulatory adherence.

3. Can regional suppliers supply OJJAARA?
Yes. Regional suppliers can offer logistical advantages and supply chain resilience, especially in regions with rapid distribution needs. However, they must meet the same quality and regulatory standards.

4. How does supply chain risk impact OJJAARA production?
Supply chain disruptions can lead to manufacturing delays, increased costs, or shortages, impacting market availability. Proactive risk management and supplier diversification are essential to mitigate these risks.

5. Is there potential for collaborative innovation with OJJAARA suppliers?
Absolutely. Strategic collaborations can optimize production processes, improve formulations, and accelerate time-to-market, providing competitive advantages.

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References
[1] U.S. Food and Drug Administration (FDA). Good Manufacturing Practices (GMP) Regulations.
[2] European Medicines Agency (EMA). Guidelines on Good Manufacturing Practice.
[3] Pharmaceutical Technology. The importance of supplier qualification in pharma.
[4] IQVIA. Supply Chain Strategies for Pharmaceuticals.
[5] Industry Reports on API manufacturing and pharmaceutical supplier ecosystems.