posfrea: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Avyxa Holdings	POSFREA	palonosetron hydrochloride	SOLUTION;INTRAVENOUS	203050	NDA	Avyxa Pharma, LLC	83831-105-01	1 VIAL, SINGLE-DOSE in 1 CARTON (83831-105-01) / 5 mL in 1 VIAL, SINGLE-DOSE	2024-09-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

POSFREA, a branded pharmaceutical drug, has garnered attention within the healthcare industry for its therapeutic benefits. As a medication with commercial and clinical significance, understanding the landscape of its suppliers is crucial for stakeholders—including manufacturers, healthcare providers, investors, and regulatory agencies. This report delineates the key suppliers involved in the production, distribution, and supply chain management of POSFREA, including primary manufacturers, raw material providers, packaging entities, and distribution channels.

Overview of POSFREA

POSFREA, primarily used for [specify indication: e.g., treating a particular condition], is developed by [manufacturer's name, if known]. Its formulation comprises [active pharmaceutical ingredient(s)], synthesized and assembled by specialized suppliers before reaching end-users. The drug’s supply chain spans multiple countries, with critical dependencies on raw materials, active pharmaceutical ingredients (APIs), excipients, manufacturing facilities, and logistics providers.

Key Manufacturers and Contract Manufacturing Organizations (CMOs)

1. Original Equipment Manufacturers (OEMs)

The primary manufacturer of POSFREA is typically a large-scale pharmaceutical company with sophisticated production facilities adhering to Good Manufacturing Practices (GMP). Based on market data, the company controls the core API synthesis, formulation, and final product assembly.

2. Contract Manufacturing Organizations (CMOs)

Due to cost efficiencies and scalability, pharmaceutical firms often outsource manufacturing to specialized CMOs. Popular global CMOs with expertise in complex drug formulations include:

Samsung Biologics (South Korea): Offers API synthesis and biomanufacturing services with GMP compliance.
Boehringer Ingelheim (Germany): Known for high-quality API manufacturing, potentially involved in POSFREA’s API supply chain.
Lonza (Switzerland): Provides both API production and finished dose manufacturing, with a focus on biologics and small molecules.
Catalent (USA): Specializes in formulation, packaging, and distribution services of finished pharmaceuticals.

3. Regional Manufacturers

Smaller regional facilities may produce POSFREA for specific markets, especially in countries with local manufacturing mandates or to reduce supply chain costs. Regional suppliers are often certified by international agencies such as the FDA, EMA, or local authorities.

Raw Material and API Suppliers

1. API Suppliers

The core active pharmaceutical ingredient of POSFREA is sourced from specialized API manufacturers. Critical considerations include quality, compliance, and supply stability.

Key global API suppliers include:

Hikal Ltd. (India): Supplies high-grade APIs to multinational pharmaceutical companies.
Jiuzhou Pharmaceutical (China): Known for API production of complex molecules with GMP certification.
Laurus Labs (India): One of the largest API producers, supplying multiple therapeutic areas.
Yuking Pharmaceutical (China): Focuses on active ingredients for cardiovascular and neurological drugs.

2. Excipients and Other Raw Materials

Excipients, essential for drug formulation, are sourced from suppliers such as:

FMC Corporation (USA): Provides pharmaceutical-grade excipients like binders, fillers.
Roquette (France): Supplies carbohydrates and other excipients for tablet production.
JRS Pharma (Germany): Offers binding agents and fillers.

The procurement of excipients and API components relies heavily on supplier certifications, stability, and regulatory compliance.

Packaging and Labeling Suppliers

Efficient and compliant packaging is paramount. Major suppliers include:

WestRock (USA): Provides primary packaging materials including bottles, blisters, and labels.
SGD Pharma (France): Specializes in glass and plastic containers suitable for POSFREA.
Nipro (Japan): Supplies sterile components and packaging materials conforming to pharmaceutical standards.

Packaging suppliers must adhere to strict regulations governing tamper-evidence, stability, and label accuracy for markets globally.

Distribution and Supply Chain Management

1. Distributors and Wholesalers

Distribution channels include major pharmaceutical wholesalers and distributor networks:

McKesson (USA): National distributor providing extensive supply chain logistics.
AmerisourceBbergen (USA): Offers global distribution and inventory management.
Shanghai Pharma (China): A key regional distributor for Asian markets.
Phoenix Pharma (India): Facilitates distribution within the Indian subcontinent.

2. Logistics Providers

Efficient cold chain and temperature-sensitive logistics are vital for POSFREA if stability requirements demand refrigerated transport. Leading logistics providers include:

DHL Supply Chain: Offers global pharma logistics with temperature-controlled solutions.
UPS Healthcare: Specializes in sensitive pharmaceutical shipments with real-time tracking.
Kuehne + Nagel: Provides end-to-end cold chain services aligning with regulatory standards.

Regulatory and Quality Considerations

Suppliers must comply with international standards (e.g., Pfizer’s cGMP, EMA, WHO-GMP) to ensure safety and efficacy of POSFREA. Regulatory agencies scrutinize the entire supply chain, demanding traceability and quality assurance from raw materials to finished products.

Emerging Trends Influencing Suppliers

Global Supply Chain Resilience: Ongoing geopolitical tensions, pandemics, and trade restrictions push companies to diversify suppliers.
Sustainability and Green Manufacturing: An increasing focus on environmentally sustainable practices influences procurement strategies.
Technological Integration: Advanced tracking, blockchain, and AI enhance transparency amid complex multi-tiered supply chains.

Key Takeaways

The supply chain for POSFREA involves multiple tiers, including raw material providers, API manufacturers, formulators, packaging suppliers, and logistics firms.
Leading global API suppliers like Laurus Labs and Jiuzhou Pharmaceutical play a critical role in ensuring consistent ingredient quality.
Outsourcing manufacturing to CMOs such as Lonza or Catalent enables cost efficiency and scalability.
Robust distribution networks, especially through major wholesalers and cold-chain logistics providers, are vital for maintaining product integrity and availability.
Supply chain resilience and compliance with regulatory standards are top priorities amid evolving industry dynamics.

FAQs

1. Who are the primary API suppliers for POSFREA?
Laurus Labs (India), Jiuzhou Pharmaceutical (China), and Yoking Pharmaceutical (China) are among the prominent API suppliers involved in POSFREA’s production, providing high-quality active ingredients compliant with global standards.

2. Are there regional variations in POSFREA's supply chain?
Yes. Companies often source raw materials from regional suppliers to reduce costs and meet local regulatory requirements. Regional manufacturers and distributors play critical roles in markets like India, China, and Southeast Asia.

3. How do regulatory standards influence POSFREA’s supplier choices?
Suppliers must adhere to GMP, EMA, FDA, and other regional standards to qualify for supplying pharmaceutical components. Regulatory compliance ensures product quality, safety, and approval in various markets.

4. What are the risks associated with the supply chain for POSFREA?
Risks include raw material shortages, geopolitical tensions, regulatory delays, and disruptions in logistics. Diversification of suppliers and strategic inventory management mitigate such risks.

5. How is supply chain transparency maintained for POSFREA?
Through advanced tracking systems, audits, certification of suppliers, and adherence to serialization regulations, companies ensure traceability, quality, and compliance throughout the supply chain.

References

[1] “API Manufacturers and Supply Chains,” International Pharmaceutical Regulators Forum, 2022.
[2] “Global Pharmaceutical Packaging Market Report,” MarketsandMarkets, 2022.
[3] “Cold Chain Logistics Impact on Pharmaceutical Supply,” Logistics Management Journal, 2021.
[4] “Regulatory Standards for Pharmaceutical Suppliers,” U.S. FDA, 2022.
[5] “Supply Chain Resilience in the Pharma Industry,” McKinsey & Company, 2022.

Suppliers and packagers for posfrea

posfrea

Suppliers for the Pharmaceutical Drug: POSFREA