.webp&w=3840&q=75 "PB-2 Capsule")
PB2 Cap is a scientifically formulated pre & probiotic capsule designed for pharmaceutical applications, combining live microbial cultures and prebiotic components to enhance microbial stability and efficacy. The formulation includes four strains of Lactobacillus (Acidophilus, Rhamnosus) and two strains of Bifidobacterium (Longum, Bifidum), each at 0.48 billion CFU, alongside 0.1 billion CFU of Saccharomyces Boulardii, a yeast known for its probiotic properties. The inclusion of 300mg fructo-oligosaccharides (FOS) serves as a prebiotic substrate to promote the growth and activity of beneficial bacteria. The capsule matrix is engineered to ensure microbial viability during storage and transit, with controlled-release properties to optimize bioavailability. The formulation adheres to pharmaceutical-grade excipient specifications, ensuring compatibility with industrial manufacturing processes and regulatory requirements.
Manufacturing Capability
Our manufacturing infrastructure is equipped to produce PB2 Cap at scale, with a dedicated facility featuring aseptic processing lines, high-capacity encapsulation systems, and advanced quality control laboratories. The facility complies with current Good Manufacturing Practices (cGMP) and maintains a Class 10,000 cleanroom environment for sterile processing, ensuring microbial contamination risks are minimized. Production scalability is supported by modular manufacturing units capable of handling bulk orders for global distribution. The facility is certified under ISO 9001 and ISO 14001 standards, reflecting our commitment to quality management and environmental responsibility. Automated systems for formulation mixing, encapsulation, and packaging ensure consistency, precision, and compliance with pharmaceutical standards.
Available Strengths and Packaging
PB2 Cap is formulated with a standardized strength of 0.48 billion CFU per strain of Lactobacillus and Bifidobacterium, 0.1 billion CFU of Saccharomyces Boulardii, and 300mg fructo-oligosaccharides. The product is available in 10x10 Alu Alu packaging, which provides an aluminum-aluminum blister pack with enhanced barrier properties to protect the microbial content from moisture, light, and oxygen. This packaging format ensures extended shelf life and compliance with pharmaceutical storage requirements, making it ideal for bulk supply and international distribution.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers’ needs. Our capabilities include private label manufacturing, where we produce PB2 Cap under a client’s brand name, ensuring full customization of packaging, labeling, and formulation specifications. We also provide contract manufacturing for bulk orders, leveraging our scalable infrastructure to meet diverse demand. Our team collaborates closely with clients to ensure adherence to regulatory standards, formulation consistency, and timely delivery. Whether you require a single batch or large-scale production, our flexible manufacturing solutions support your global supply chain requirements.
Quality Assurance
Quality assurance for PB2 Cap is ensured through rigorous control systems, including in-process testing, batch validation, and final product analysis. Each production batch undergoes microbial testing to confirm sterility and absence of contaminants, alongside potency assays to verify CFU counts and prebiotic content. Analytical validation is performed using HPLC and spectrophotometric methods to quantify fructo-oligosaccharides and ensure formulation accuracy. Our quality control team adheres to ICH and USP guidelines, with documentation compliant with FDA and EMA requirements. All products are tested for stability, dissolution, and physical characteristics to guarantee consistency and safety for industrial and global supply.
Regulatory Compliance
PB2 Cap is manufactured in full compliance with global regulatory frameworks, including cGMP, WHO guidelines, and ISO 9001/14001 standards. Our facility is registered with the FDA, EMA, and regulatory authorities in key markets, ensuring adherence to international quality and safety protocols. The product meets specifications for pharmaceutical-grade ingredients, with documentation supporting compliance with pharmacopeial standards. We provide regulatory support for market entry, including dossier preparation, labeling compliance, and export documentation, enabling seamless distribution across regions.
Global Supply Capability
Our global supply capability is supported by a well-established international distribution network, with logistics infrastructure to handle bulk shipments to over 50 countries. We offer export solutions tailored to pharmaceutical buyers, including customs clearance, documentation, and compliance with import regulations. Bulk supply capacity is optimized through automated packaging lines and warehousing facilities, ensuring timely delivery and supply chain reliability. Our team prioritizes supply chain resilience, with contingency planning to mitigate disruptions and maintain uninterrupted production.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our proven track record in quality manufacturing, regulatory compliance, and global supply efficiency. Our commitment to cGMP standards, advanced infrastructure, and scalable production ensures reliable delivery of PB2 Cap to meet market demands. As a trusted supplier, we provide end-to-end solutions, from formulation to export, with dedicated support for compliance and logistics. Our focus on innovation, sustainability, and customer collaboration positions us as a strategic partner for pharmaceutical buyers seeking reliable, high-quality products.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our sales team at info@delwishealthcare.com to discuss customization, pricing, and logistics for your pharmaceutical requirements.
FAQs
What manufacturing standards does PB2 Cap comply with?
PB2 Cap is manufactured in compliance with cGMP, ISO 9001, and WHO guidelines, ensuring adherence to global pharmaceutical standards.
Can PB2 Cap be produced in different packaging formats?
Yes, we offer flexible packaging solutions, including 10x10 Alu Alu and other formats, to meet specific supply chain and regulatory requirements.
What is the shelf life of PB2 Cap?
The product has a shelf life of 24 months when stored under recommended conditions, with packaging designed to maintain stability.
Does PB2 Cap require special storage conditions?
PB2 Cap should be stored in a cool, dry place away from direct sunlight to preserve microbial viability.
Can PB2 Cap be customized for private label manufacturing?
Yes, we provide private label manufacturing services, allowing clients to brand the product under their own name.
What regulatory documentation is provided with PB2 Cap?
We supply complete regulatory documentation, including batch certificates, analytical reports, and compliance certificates for global markets.
How does your supply chain ensure reliability?
Our logistics network includes customs clearance, real-time tracking, and contingency planning to ensure timely and reliable delivery.
Can you handle large-scale bulk orders?
Yes, our scalable manufacturing infrastructure supports bulk production to meet the demands of global pharmaceutical buyers.
What quality tests are performed on PB2 Cap?
Each batch undergoes microbial testing, potency assays, and analytical validation to ensure consistency and safety.
How do you support export compliance for PB2 Cap?
We provide export documentation, compliance certifications, and regulatory guidance to facilitate seamless international distribution.
