Tofu is a dual-action ophthalmic solution formulated with Tobaramycine (3%) and Flurometyhalone (0.1%) in a sterile, isotonic base. The formulation is designed to ensure optimal solubility, stability, and compatibility of active ingredients while maintaining a pH range suitable for ocular application. Tobaramycine, a broad-spectrum aminoglycoside antibiotic, is combined with Flurometyhalone, a non-steroidal anti-inflammatory agent, to create a balanced therapeutic profile. The excipients include purified water, sodium chloride, and benzyl alcohol as a preservative, ensuring microbial stability and compatibility with ocular tissues. The formulation process involves precise mixing, filtration, and aseptic filling to meet pharmaceutical standards. The product’s stability under varying storage conditions ensures consistent performance, making it suitable for long-term use in pharmaceutical manufacturing.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001 standards. The facility includes ISO Class 7/8 cleanrooms for sterile processing, advanced aseptic filling lines, and automated quality control systems. We specialize in large-scale production of sterile eye drops, with the capacity to scale from small batches to bulk supply. Our quality systems encompass rigorous validation of equipment, process controls, and documentation to ensure reproducibility and consistency. The manufacturing process includes real-time monitoring of critical parameters such as temperature, humidity, and microbial load to guarantee product integrity. Additionally, our facility is designed to handle multiple product lines, enabling flexibility for pharmaceutical buyers requiring customized formulations.
Available Strengths and Packaging
Tofu is available in the following strengths: Tobaramycine 3% and Flurometyhalone 0.1%. The product is packaged in 5ml single-dose vials, ensuring convenience and sterility for end-use applications. The packaging is designed to maintain product stability during transportation and storage while meeting regulatory requirements for pharmaceutical packaging.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our capabilities include private label manufacturing, where we produce branded products under a client’s name, and contract manufacturing for OEM/ODM solutions. We support clients in developing custom formulations, packaging, and labeling, adhering to their specifications while maintaining compliance with global regulatory standards. Our team collaborates closely with clients to ensure alignment with their market requirements, including export-specific packaging and labeling. This flexibility makes us an ideal partner for pharmaceutical suppliers and exporters seeking scalable, high-quality production.
Quality Assurance
Our quality assurance framework is built on rigorous testing, analytical validation, and adherence to pharmaceutical standards. Each batch undergoes comprehensive testing for sterility, pH, osmolarity, and active ingredient concentration using High-Performance Liquid Chromatography (HPLC) and microbial limit tests. We validate analytical methods to ensure accuracy and reproducibility, with documented protocols for each step of the manufacturing process. Quality control systems include in-process checks, final product testing, and stability studies to confirm shelf life and efficacy. Our commitment to quality is further reinforced by regular internal audits and third-party inspections to maintain compliance with ICH and WHO guidelines.
Regulatory Compliance
Tofu is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001 standards. Our facility is certified by regulatory authorities in multiple regions, including the FDA, EMA, and PIC/S, ensuring global market access. We adhere to WHO’s guidelines for pharmaceutical quality, including documentation, traceability, and batch-specific records. Our compliance with ISO 11135 and ISO 11137 standards for sterilization processes guarantees product safety. Additionally, we maintain regulatory filings for export markets, ensuring Tofu meets the specific requirements of target regions. This compliance framework positions us as a reliable supplier for pharmaceutical manufacturers and exporters.
Global Supply Capability
We provide robust global supply capabilities, including export to over 150 countries and a well-established international distribution network. Our bulk supply capacity allows us to meet the demands of large-scale pharmaceutical buyers, with logistics partnerships ensuring timely delivery. The supply chain is designed for reliability, with redundant systems to mitigate disruptions and ensure consistent availability. We support both small and large orders, offering flexible shipping options and compliance with international trade regulations. Our ability to scale production and maintain supply chain resilience makes us a preferred partner for bulk supply inquiries.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality, scalable production. Our commitment to compliance, coupled with advanced manufacturing capabilities, ensures reliable supply chains and market-ready products. We offer competitive pricing, rapid turnaround times, and personalized support to meet the unique needs of our clients. With a proven track record in the pharmaceutical industry, we provide end-to-end solutions that align with global regulatory standards, making us a trusted manufacturer and supplier for B2B buyers.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to supporting pharmaceutical manufacturers and exporters with customized solutions for global distribution.
FAQs
What is the shelf life of Tofu?
Tofu has a shelf life of 24 months when stored at 2–8°C, as confirmed by stability studies and regulatory filings.
Can Tofu be customized for specific markets?
Yes, we offer private label manufacturing and packaging customization to meet regional regulatory and branding requirements.
What certifications does your facility hold?
Our facility is certified under GMP, ISO 9001, and ISO 11135/11137 standards, with compliance verified by FDA, EMA, and PIC/S.
How do you ensure sterility during manufacturing?
Sterility is maintained through ISO Class 7/8 cleanrooms, aseptic filling lines, and validated sterilization processes.
What is your minimum order quantity for bulk supply?
We accommodate small and large orders, with minimum quantities tailored to client requirements.
Can you support export to specific regions?
Yes, we provide export-ready packaging, labeling, and regulatory documentation for markets including the EU, US, Asia, and Africa.
How do you handle quality control for each batch?
Each batch undergoes sterility testing, HPLC analysis, and microbial limit checks, with full documentation for traceability.
What is your production scalability for Tofu?
Our facility is designed for scalable production, with the capacity to meet both small and large-scale bulk supply demands.
Do you offer contract manufacturing for other products?
Yes, we provide contract manufacturing services for a range of pharmaceutical products, including eye drops, topical solutions, and injectables.
How can I request a sample or quotation?
Contact us at **info@delwishealthcare.com** for sample requests, technical specifications, and tailored quotations.
