NALLPEN IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	NALLPEN IN PLASTIC CONTAINER	nafcillin sodium	INJECTABLE;INJECTION	050655	NDA	Baxter Healthcare Corporation	0338-1019-48	100 mL in 1 BAG (0338-1019-48)	1989-10-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

The pharmaceutical industry relies heavily on the sourcing of both active pharmaceutical ingredients (APIs) and packaging materials to ensure quality, efficacy, and safety. When considering the supply chain for a drug like NALLPEN, particularly packaged in plastic containers, it is essential to identify reputable suppliers of the drug itself and those supplying high-quality plastic containers. NALLPEN, an injection drug, is commonly used for deep vein thrombosis and pulmonary embolism, and its packaging plays a critical role in maintaining sterility and stability. Consequently, sourcing reliable suppliers for both the pharmaceutical and packaging components is an integral part of risk management, regulatory compliance, and supply chain resilience.

Understanding NALLPEN and its Packaging

NALLPEN contains the active component nadroparin calcium, a low molecular weight heparin. It is supplied in pre-filled syringes or vials, typically housed within plastic containers that serve for transportation, storage, and handling. The plastic container, often made from high-grade medical-grade polypropylene or PET (polyethylene terephthalate), must meet rigorous standards:

Sterility and biocompatibility: To prevent contamination
Chemical inertness: To avoid interactions with the drug
Durability and transparency: For visual inspection

Packaging suppliers specialize in manufacturing containers that conform to pharmacopeial standards, ensuring compliance with global regulatory requirements such as those from the FDA, EMA, or WHO.

Key Suppliers of Pharmaceutical-grade Packaging for NALLPEN

1. Leading Global Plastic Container Manufacturers

a) Gerresheimer AG

Overview: A German firm with a global footprint, Gerresheimer supplies high-quality drug delivery systems including plastic containers, prefilled syringes, and cartridges.
Product Offerings: Polypropylene and PET containers suitable for pharmaceuticals, including prefilled syringes with integrated stoppers.
Certifications: ISO 15378, CE, and FDA approvals.

b) West Pharmaceutical Services

Overview: An industry leader known for precision manufacturing of primary packaging components for injectables.
Product Offerings: Plastic containers, stoppers, and seals designed for compatibility with injectable drugs.
Certifications: cGMP, ISO 9001.

c) Schott AG

Overview: A German glass and plastic packaging supplier with a focus on healthcare.
Product Offerings: Blister packs, cartridges, and sterile plastic containers.
Certifications: ISO 13485, GMP compliance.

d) Nipro Corporation

Overview: Japanese manufacturer with a broad portfolio of medical packaging, including plastic containers for pharmaceuticals.
Product Offerings: Medical-grade plastics used for prefilled syringes and containers.
Certifications: ISO and GMP standards.

Specialized Suppliers of Pharmaceutical-grade Plastic Containers

2. Regional and Custom Containers Suppliers

a) Medisca

Region: North America
Offering: Customizable plastic containers and sterile packaging solutions.

b) Almeida & Sons

Region: India
Offering: Cost-effective plastic bottles and containers for pharmaceutical applications.

c) NuoNuo Packaging

Region: Asia-Pacific
Offering: Lightweight, sterile plastic bottles in various sizes designed for injectables.

Key Factors in Selecting Suppliers for NALLPEN Packaging

Regulatory compliance: Suppliers must meet international standards such as ISO 13485, cGMP, and approvals specific to the target markets (FDA, EMA).
Material quality: Medical-grade polymers like polypropylene or PET, with proven inertness and stability.
Sterility assurance: Robust sterilization processes (e.g., ethylene oxide, gamma irradiation).
Compatibility: Ensuring the container material does not interact adversely with nadroparin calcium.
Supply chain reliability: Ability to meet large-volume demands with consistent quality and timely delivery.

Current Market Trends and Challenges

Supply chain disruptions: Global logistic constraints can impact the availability of raw materials and packaging containers.
Regulatory hurdles: Compliance with evolving quality standards necessitates ongoing validation and certification.
Sustainable packaging initiatives: Transition toward biodegradable or recyclable plastics to meet environmental standards.
Customization needs: Growing demand for tailored containers with specific features like volume, venting, or closure systems.

Strategic Sourcing Approaches

Partner with multiple suppliers: To mitigate risks related to supply shortages or quality issues.
Engage in early qualification: Engage suppliers early to validate compliance and manufacturing capabilities.
Leverage regional manufacturing hubs: For cost savings and reduced lead times.
Implement quality audits: Regular inspections and audits to ensure ongoing compliance.

Conclusion

The procurement of high-quality plastic containers for NALLPEN necessitates selecting reputable, compliant suppliers capable of delivering sterile, inert, and durable packaging solutions. Leading global manufacturers such as Gerresheimer, West Pharmaceutical Services, Schott AG, and Nipro are prominent providers in this space, complemented by regional suppliers offering tailored or cost-effective options. Strategic sourcing, rigorous qualification, and ongoing quality assurance are crucial for maintaining supply chain resilience and ensuring patient safety.

Key Takeaways

Regulatory and quality compliance are non-negotiable for pharmaceutical plastic container suppliers.
Global leaders like Gerresheimer and West Pharmaceutical dominate the market but regional suppliers can provide cost-effective alternatives.
Material inertness and sterility assurance are vital for maintaining drug stability and safety in NALLPEN packaging.
Diversified sourcing reduces dependency on single suppliers, mitigating supply chain risks.
Emerging trends include sustainable packaging initiatives and customized container designs to meet evolving clinical and regulatory requirements.

FAQs

1. What are the primary materials used for plastic containers for NALLPEN?
High-grade medical polypropylene and PET are commonly used due to their inertness, clarity, and compatibility with injectable drugs, ensuring sterility and drug stability.

2. How do suppliers ensure the sterility of plastic containers?
Sterilization methods such as gamma irradiation or ethylene oxide treatment are employed, with rigorous validation to ensure containers meet bioburden and endotoxin standards.

3. Are there regional suppliers capable of delivering containers for NALLPEN?
Yes, regional suppliers in North America, Europe, and Asia-Pacific offer customizable, sterile plastic containers suited for local market regulations and demand.

4. What regulatory standards should suppliers of pharmaceutical plastic containers meet?
They should comply with ISO 13485, cGMP guidelines, and various approvals (FDA, EMA) relevant to the destination markets.

5. How does sustainability impact the selection of plastic containers for pharmaceuticals?
Growing environmental concerns lead to the adoption of recyclable and biodegradable plastics, although material inertness and sterility remain primary considerations.

Sources

Gerresheimer AG, "Pharmaceutical Packaging Solutions," Gerresheimer Official Website.
West Pharmaceutical Services, "Drug Delivery & Packaging Solutions," West Pharma.
Schott AG, "Healthcare Packaging," Schott Medical Solutions.
Nipro Corporation, "Medical Packaging," Nipro Official Website.
regulatory standards including ISO 13485 and cGMP guidelines, World Health Organization (WHO) and FDA publications.

Suppliers and packagers for NALLPEN IN PLASTIC CONTAINER