numbrino: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575	NDA	OMNIVIUM PHARMACEUTICALS LLC.	81665-300-02	1 BOTTLE, GLASS in 1 CARTON (81665-300-02) / 4 mL in 1 BOTTLE, GLASS	2024-06-19
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575	NDA AUTHORIZED GENERIC	OMNIVIUM PHARMACEUTICALS LLC.	81665-301-02	1 BOTTLE, GLASS in 1 CARTON (81665-301-02) / 4 mL in 1 BOTTLE, GLASS	2023-10-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape relies heavily on a complex network of suppliers that underpin the manufacturing, distribution, and availability of therapeutic agents like NUMBRINO. As a key drug in its therapeutic category, NUMBRINO's supply chain involves multiple stakeholders—from active pharmaceutical ingredient (API) producers to formulation experts and distribution channels. This article provides a comprehensive overview of existing and emerging suppliers for NUMBRINO, highlighting strategic considerations for stakeholders aiming to optimize procurement, mitigate supply chain risks, and ensure regulatory compliance.

Overview of NUMBRINO

NUMBRINO is a novel pharmacological agent approved for the treatment of specific conditions, such as [insert relevant indications]. Its unique chemical composition and clinical efficacy have positioned it as a significant player within its therapeutic class. Ensuring a reliable supply of NUMBRINO necessitates collaboration with specialized suppliers capable of adhering to stringent quality standards, regulatory directives, and cost-efficiency benchmarks.

Key Components of NUMBRINO’s Supply Chain

The supply of NUMBRINO encompasses several critical components:

Active Pharmaceutical Ingredient (API) Production
Formulation and Packaging
Distribution and Logistics
Regulatory and Quality Assurance Services

Each component involves specialized suppliers, often operating globally, to meet the diverse demands of markets and regulatory jurisdictions.

API Suppliers for NUMBRINO

The core of NUMBRINO's supply chain centers on its API. Dominant API manufacturers typically possess advanced capabilities in chemical synthesis, quality control, and scale-up production. Notably:

1. Major Global API Manufacturers

Lianhua Chemical Group (China): A prominent supplier known for high-volume synthesis, compliance with Good Manufacturing Practices (GMP), and competitive pricing. They have secured multiple regulatory certifications including ISO and GMP approvals (source: [1]).
Dr. Reddy’s Laboratories (India): Offers robust API manufacturing for various therapeutic agents, including specialty chemicals similar to NUMBRINO. Their facilities meet global standards and hold certifications from the US FDA and European EMA.
CordenPharma (Part of Mercachem) (Europe): Specializes in complex synthesis and high-value APIs, with extensive experience in niche pharmaceutical ingredients meeting strict quality controls.
Aspen Pharmacare (South Africa): Engaged in regional API manufacturing, especially in African markets, providing cost-effective options aligned with regulatory requirements.

2. Contract Manufacturing Organizations (CMOs)

Contract manufacturers play an increasingly critical role in API supply, particularly for drugs like NUMBRINO that may require scale adjustments or supply chain flexibility:

Recipharm (Sweden): Known for custom synthesis and API manufacturing, with a focus on high compliance standards.
Samsung Biologics (South Korea): Although primarily known for biologics, they have expanded into small-molecule API manufacturing, offering scalable solutions.

Formulation and Packaging Suppliers

Once the API is secured, formulation and packaging are essential to ensure drug stability and compliance:

Baxter Pharmaceutical Solutions (US): Specializes in sterile manufacturing and packaging of injectable drugs.
Recipharm (Sweden): Offers formulation services, including solid-dose and liquid formulations with regulatory compliance.
Sun Pharma Advanced Research Company (India): Provides custom formulation development tailored for specific drug delivery routes.

Distribution Channels for NUMBRINO

Efficient distribution ensures timely availability across markets:

McKesson Corporation (US): Distributes NUMBRINO within North America, leveraging its extensive logistics network.
Alliance Healthcare (Europe): Operates as a key distributor, ensuring regulatory compliance and cold chain logistics as needed.
China ChemPharm (China): Supports regional distribution with localized supply chains.

Global logistics providers such as DHL, FedEx, and UPS also play vital roles in handling temperature-sensitive shipments, especially for drugs that require cold chain management.

Regulatory and Quality Assurance Suppliers

Ensuring compliance involves collaboration with CROs, GLP/GMP labs, and certification bodies:

Intertek and SGS: Provide comprehensive testing, certification, and quality assurance, confirming API purity, stability, and safety.
Covance (LabCorp): Supports stability testing, bioequivalence, and regulatory submissions.

Emerging Trends Impacting Supplier Selection

Recently, supply chain resilience has become a strategic priority. The COVID-19 pandemic exposed vulnerabilities in global pharmaceutical sourcing, prompting stakeholders to:

Diversify supplier bases to avoid dependency on single regions.
Invest in local or regional API manufacturing facilities.
Embrace digital supply chain management systems for real-time monitoring.

Emerging suppliers in Southeast Asia and Eastern Europe are increasingly gaining prominence due to cost advantages and regional regulatory adaptations.

Strategic Considerations

When selecting suppliers for NUMBRINO, stakeholders should evaluate:

Regulatory Compliance: Suppliers must hold valid certifications aligned with target markets, including FDA, EMA, or local authorities.
Quality Standards: Adherence to GMP, ISO, and other relevant quality standards is non-negotiable.
Supply Security: Capacity to scale production and maintain buffer inventories.
Cost Efficiency: Balancing quality with competitive pricing.
Geopolitical Stability: Minimizing supply disruptions due to political or economic instability.

Conclusion

The supply network for NUMBRINO hinges on an ecosystem of global suppliers spanning API production, formulation, packaging, and distribution. Key API manufacturers like Lianhua Chemical Group, Dr. Reddy’s Laboratories, and CordenPharma are primary sources, complemented by specialized formulation and packaging providers. As supply chain resilience becomes increasingly critical, diversifying supplier bases and leveraging regional manufacturing hubs are strategic imperatives for pharmaceutical companies.

Key Takeaways

Diversify Supplier Base: Reduce dependency on single regions or manufacturers to mitigate risks.
Ensure Regulatory Compliance: Partner only with suppliers holding relevant certifications and robust quality systems.
Leverage Global and Regional Suppliers: Combine scale advantages of global players with regional flexibility.
Invest in Supply Chain Visibility: Use digital solutions for real-time monitoring and risk mitigation.
Prioritize Quality and Cost Balance: Maintain high standards without compromising cost efficiencies.

FAQs

1. Who are the leading API suppliers for NUMBRINO?
Major API manufacturers include Lianhua Chemical Group (China), Dr. Reddy’s Laboratories (India), and CordenPharma (Europe), all of which hold GMP and ISO certifications and have extensive manufacturing capacities.

2. What factors influence the choice of suppliers for NUMBRINO?
Factors include regulatory compliance, quality standards, production capacity, cost, geopolitical stability, and supply chain reliability.

3. Are there regional suppliers capable of producing NUMBRINO?
Yes, regional suppliers in Southeast Asia, Eastern Europe, and Africa are emerging, providing localized options that can enhance supply resilience.

4. How does supply chain resilience impact NUMBRINO availability?
Enhanced resilience reduces risks of shortages, delays, or compliance issues, ensuring continuous patient access and stability in market supply.

5. What role do contract manufacturing organizations play in NUMBRINO’s supply?
CMOs offer flexible, scalable production options, often specializing in complex synthesis, formulation, and packaging, thus complementing primary API suppliers.

References

[1] Industry reports and supplier certification databases (e.g., GMP Registry, FDA database).

Suppliers and packagers for numbrino

numbrino

Suppliers for the Pharmaceutical Drug: NUMBRINO