BACTOCILL IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	BACTOCILL IN PLASTIC CONTAINER	oxacillin sodium	INJECTABLE;INJECTION	050640	NDA	Baxter Healthcare Corporation	0338-1015-41	50 mL in 1 BAG (0338-1015-41)	1989-10-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 4, 2025

Introduction

The pharmaceutical industry’s supply chain for antibiotics such as BACTOCILL (a brand often associated with Amoxicillin formulations) necessitates meticulous sourcing of raw materials, active pharmaceutical ingredients (APIs), excipients, and packaging components. For BACTOCILL supplied in plastic containers, it is crucial to identify reliable vendors capable of adhering to stringent quality, regulatory, and safety standards to ensure product integrity and compliance.

This article provides a comprehensive analysis of key suppliers involved in the production, raw material sourcing, and packaging of BACTOCILL in plastic containers. Emphasis is placed on global manufacturers, their capabilities, and compliance infrastructure, enabling pharmaceutical companies to optimize procurement strategies.

Raw Material and API Suppliers

Active Pharmaceutical Ingredient (API) Producers

The core of BACTOCILL’s formulation centers on Amoxicillin trihydrate, a broad-spectrum penicillin antibiotic. Several pharmaceutical-grade API manufacturers dominate the global market, offering high-quality Amoxicillin suitable for finished dosage form (FDF) production.

Sun Pharmaceutical Industries Ltd.
Sun Pharma ranks among the largest APIs producers worldwide, with extensive facilities manufacturing Amoxicillin. Its APIs are compliant with USFDA, EMA, and other global regulatory standards, making it a preferred choice for generic antibiotic manufacturing [1].
Hikma Pharmaceuticals plc.
Hikma supplies high-grade Amoxicillin APIs, emphasizing consistent batch quality, adherence to GMP, and global regulatory approvals for their manufacturing sites.
Aurobindo Pharma Limited
Aurobindo offers a broad portfolio of antibiotics, including Amoxicillin, with significant export reach. Their APIs are certified by major regulatory agencies, faciliating global supply.
Mannkind Technologies Inc.
Specializes in producing pharmaceutical-grade APIs with an emphasis on compliance with international manufacturing practices, serving generic and innovator drug producers.
Kusum Pharmachem Ltd.
An Indian manufacturer that supplies APIs to the domestic and global markets, with ongoing efforts to expand their API production capabilities and quality certifications.

Raw Material Excipients Suppliers

Excipients such as fillers, binders, solvents, and preservatives are critical in tablet and capsule formulations. Suppliers like Draxis Pharma, Colorcon Inc., and Norevo provide high-quality excipients compliant with pharmacopeial standards, crucial for maintaining product stability.

Manufacturers of BACTOCILL in Finished Form

Most pharmaceutical companies producing BACTOCILL in plastic containers source APIs and excipients from multiple suppliers, assemblying final products in GMP-certified facilities.

GlaxoSmithKline (GSK)
Historically associated with BACTOCILL and other Amoxicillin-based antibiotics, GSK’s manufacturing facilities are globally certified, and they employ rigorous quality control measures for their finished products.
Sandoz (Novartis division)
As a leading generics manufacturer, Sandoz supplies BACTOCILL formulations in plastic containers, leveraging a global supply chain of high-quality APIs and excipients.
Amneal Pharmaceuticals
Known for cost-effective antibiotics, Amneal sources APIs from Indian and international suppliers with WHO-GMP certification, assembling BACTOCILL in their facilities.
Mylan/Norhund
Mylan, now part of Viatris, produces BACTOCILL formulations in various markets, aligning with strict regulatory standards.

Packaging Suppliers for Plastic Containers

The packaging of BACTOCILL in plastic containers involves sourcing high-grade polyethylene or polypropylene bottles that meet pharmaceutical packaging standards, including compatibility, barrier properties, and tamper-evidence.

Primary Packaging Suppliers

Gerresheimer AG
A global leader in pharmaceutical and medical packaging, providing high-quality plastic bottles suitable for antibiotics. Their containers are certified and comply with ISO standards.
AptarGroup Inc.
Supplying dispensing and closure systems, Aptar offers plastic bottles with child-resistant features and tamper-evident caps appropriate for pharmaceutical applications.
Berry Global Inc.
Provides a wide variety of plastic containers designed specifically for pharmaceuticals, with customizable features and compliance to pharmacopeial standards.
Gerard Spectacle Plastic (GSP)
A specialized manufacturer of pharmaceutical-grade bottles, offering various molding options tailored for antibiotics.

Secondary Packaging Components

West Pharmaceutical
Supplies sealing and tamper-evident caps that ensure product stability and safety throughout the supply chain.
Nemera
Offers customized closure solutions, ensuring airtight seals compatible with plastic containers.

Regulatory and Quality Considerations

Suppliers for BACTOCILL in plastic containers must comply with multiple regulations:

GMP (Good Manufacturing Practice)
Ensures consistent quality of manufacturing processes, critical for APIs, excipients, and packaging components.
FDA, EMA, and WHO Approvals
Suppliers must hold certifications or approval for their manufacturing sites and products.
ISO Certifications
ISO 9001 and ISO 15378 certifications validate quality management and pharmaceutical packaging standards.

Establishing supplier audits and validation protocols aids in mitigating risks related to contamination, counterfeit, or substandard materials.

Strategies for Selecting Reliable Suppliers

Regulatory Compliance: Prioritize suppliers with current certifications and active regulatory approvals.
Quality Track Record: Review past audits, batch consistency, and incident reports.
Capacity and Scalability: Ensure suppliers can meet current and future demand.
Supply Chain Security: Opt for diversified sourcing to mitigate supply disruptions.
Cost and Lead Time: Balance quality with competitive pricing and reliable delivery schedules.

Key Takeaways

API sourcing is centralized around leading Indian and global manufacturers like Sun Pharma, Aurobindo, and Hikma, which offer GMP-compliant Amoxicillin trihydrate suitable for BACTOCILL production.
High-quality excipients are procured from established providers such as Draxis Pharma and Colorcon to ensure formulation stability and compliance.
Finished BACTOCILL formulations in plastic containers are typically produced by global generic manufacturers like Sandoz, Amneal, and Mylan, leveraging their extensive supply chain networks.
Plastic container suppliers like Gerresheimer, Aptar, Berry, and Gerard Spectacle Plastic deliver pharmaceutical-grade bottles with compliance certifications that meet regulatory standards for safety and stability.
Robust supplier qualification, adherence to regulatory requirements, and diversified sourcing strategies are essential to mitigate risks in the BACTOCILL supply chain.

FAQs

Q1: What are the key factors when selecting a supplier for BACTOCILL in plastic containers?
A1: Regulatory compliance, quality certification, manufacturing capacity, supply reliability, cost-effectiveness, and ability to meet specific packaging requirements.

Q2: Are there specific regulatory certifications that suppliers must hold?
A2: Yes. Suppliers should have GMP certification, ISO 9001/15378, and approvals from relevant regulatory authorities like FDA or EMA.

Q3: How does the choice of plastic container material impact drug stability?
A3: Materials such as HDPE or PP must be compatible with the drug to avoid reactions, ensure barrier properties for preventing moisture or oxygen ingress, and meet safety standards.

Q4: Can I source APIs from multiple suppliers for BACTOCILL production?
A4: Yes, but it requires rigorous quality assurance processes and validation to ensure batch consistency and regulatory compliance across sources.

Q5: What measures ensure supply chain security for BACTOCILL in plastic containers?
A5: Diversified sourcing, supplier qualification audits, supply contracts with contingency clauses, and ongoing quality monitoring.

References

[1] Sun Pharmaceutical Industries Ltd. Official Website. API manufacturing capabilities and certifications.
[2] EMA and FDA regulatory approval reports for Amoxicillin API manufacturers.
[3] Global Pharmaceutical Packaging Market Reports - Gerresheimer, Aptar, Berry Global, and Gerard Spectacle Plastic.

This analysis aims to assist pharmaceutical professionals and procurement teams in identifying reliable suppliers for BACTOCILL in plastic containers, emphasizing regulatory compliance, quality assurance, and supply chain robustness.

Suppliers and packagers for BACTOCILL IN PLASTIC CONTAINER