PB2 Sachet is a scientifically formulated pre & pro-biotic blend engineered for pharmaceutical applications, combining live bacterial cultures with prebiotic support to ensure stability, efficacy, and compliance with regulatory standards. The formulation includes Lactobacillus Acidophilus, Lactobacillus Rhamnosus, Bifidobacterium Longum, Bifidobacterium Bifidum, and Saccharomyces Boulardii, each selected for their established roles in gut microbiome modulation. The inclusion of Fructo Oligo Saccharides (FOS) enhances the viability of probiotic strains by acting as a prebiotic substrate, promoting selective bacterial growth. The product is designed with a 1gm sachet format, optimized for controlled release and minimal exposure to environmental factors that could compromise microbial viability. Formulation stability is achieved through advanced excipient selection and controlled moisture management, ensuring consistent potency and shelf life. The composition adheres to pharmaceutical-grade specifications, with precise CFU counts and prebiotic ratios tailored for industrial scalability and quality assurance.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities designed to meet the stringent requirements of pharmaceutical production. The facility includes a dedicated sterile processing area for probiotic formulation, ensuring contamination-free handling of live cultures. All production processes comply with current Good Manufacturing Practices (cGMP), with rigorous validation protocols for equipment, processes, and environmental controls. The facility supports scalable production, enabling seamless transitions from small batch trials to large-scale commercial runs while maintaining consistency in product quality. Advanced quality systems, including real-time monitoring and automated data collection, ensure traceability and compliance with regulatory standards. Additionally, the infrastructure is designed for flexibility, accommodating custom formulation adjustments and packaging modifications to meet diverse client specifications.
Available Strengths and Packaging
PB2 Sachet is available in a standardized strength of 1gm per sachet, containing the specified microbial and prebiotic composition. The product is packaged in 20 x 1gm sachets, ensuring optimal protection for the probiotic strains while facilitating convenient storage and distribution. The sachet design is engineered for durability, moisture resistance, and ease of handling, making it suitable for both bulk supply and retail applications. The packaging format is ideal for pharmaceutical manufacturers requiring consistent dosing and shelf-stable products for global markets.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to the needs of pharmaceutical buyers. Our capabilities include private label manufacturing, where we produce branded probiotic products under a client’s own label, ensuring full control over branding and packaging. We also provide flexible contract manufacturing solutions, enabling clients to leverage our expertise in formulation development, quality control, and regulatory compliance while maintaining ownership of the product lifecycle. Our team collaborates closely with clients to design customized formulations, optimize production processes, and ensure adherence to global regulatory standards. Whether you require a single product line or a multi-product portfolio, our scalable infrastructure and technical expertise support efficient, cost-effective manufacturing for pharmaceutical suppliers and exporters.
Quality Assurance
Our quality assurance systems are built on a foundation of rigorous testing, analytical validation, and compliance with pharmaceutical standards. Every batch of PB2 Sachet undergoes comprehensive quality control checks, including microbial contamination testing, potency analysis, and stability studies to ensure consistency and safety. Advanced analytical techniques, such as high-performance liquid chromatography (HPLC) and microbial enumeration, validate the CFU counts and prebiotic content of each sachet. Batch testing is conducted at multiple stages of production to identify and mitigate deviations, while documentation systems ensure full traceability and regulatory transparency. Our quality control protocols align with international standards, including ISO 9001 and FDA guidelines, ensuring that all products meet the highest benchmarks for purity, efficacy, and safety.
Regulatory Compliance
PB2 Sachet is manufactured in full compliance with global regulatory frameworks, including current Good Manufacturing Practices (cGMP), World Health Organization (WHO) guidelines, and ISO 9001 quality management standards. Our facility is certified to meet the requirements of regulatory bodies such as the U.S. FDA, EU GMP, and ICH guidelines, ensuring that products are suitable for international markets. We maintain detailed documentation for all production processes, raw material sourcing, and quality control measures, facilitating audits and regulatory submissions. Compliance with these standards ensures that PB2 Sachet meets the stringent requirements of pharmaceutical buyers seeking to export to diverse regions, including the EU, Asia-Pacific, and North America.
Global Supply Capability
Our global supply capability is supported by an extensive international distribution network and robust logistics infrastructure, enabling seamless bulk supply to markets worldwide. We specialize in exporting pharmaceutical products to over 50 countries, with a focus on maintaining supply chain reliability through strategic partnerships with logistics providers and customs clearance experts. Our bulk supply capacity is designed to meet the demands of large-scale distributors and exporters, with flexible order fulfillment options to accommodate varying volume requirements. The facility’s capacity for high-volume production, combined with efficient packaging and storage solutions, ensures timely delivery without compromising product integrity. Additionally, our supply chain resilience is reinforced by redundant systems and contingency planning, ensuring uninterrupted operations even in the face of global disruptions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our commitment to quality, compliance, and scalability. Our expertise in probiotic formulation and cGMP manufacturing ensures that PB2 Sachet meets the highest standards for pharmaceutical applications. As a trusted supplier, we offer competitive pricing, rapid turnaround times, and personalized support to meet the unique needs of our clients. Our global supply network and regulatory compliance expertise enable seamless entry into international markets, while our flexible manufacturing capabilities allow for customization and innovation. By partnering with us, you gain access to a reliable, high-quality product that aligns with your business objectives and regulatory requirements.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our sales team at info@delwishealthcare.com. Our team is dedicated to providing tailored solutions for pharmaceutical manufacturers, exporters, and distributors seeking reliable, high-quality probiotic products for global markets.
FAQs
What is the CFU count for each probiotic strain in PB2 Sachet?
PB2 Sachet contains 1.5 billion CFU of Lactobacillus Acidophilus and Lactobacillus Rhamnosus, 0.40 billion CFU of Bifidobacterium Longum, 0.25 billion CFU of Bifidobacterium Bifidum, and 0.05 billion CFU of Saccharomyces Boulardii.
Is PB2 Sachet suitable for pharmaceutical manufacturing?
Yes, PB2 Sachet is formulated to meet pharmaceutical standards, with a stable, scalable composition designed for industrial production and regulatory compliance.
What certifications does your facility hold?
Our facility is certified under cGMP, ISO 9001, and WHO guidelines, ensuring compliance with global regulatory standards for pharmaceutical manufacturing.
Can you customize the packaging for PB2 Sachet?
Yes, we offer flexible packaging solutions, including the standard 20 x 1gm sachet format, and can accommodate custom designs for private label or export requirements.
What is the shelf life of PB2 Sachet?
PB2 Sachet has a shelf life of 24 months when stored under recommended conditions, with stability validated through rigorous testing.
Do you provide third-party testing for quality assurance?
Yes, all batches undergo third-party testing for microbial contamination, potency, and stability to ensure compliance with pharmaceutical standards.
Can PB2 Sachet be exported to international markets?
Yes, our products are compliant with global regulatory frameworks, enabling seamless export to markets in the EU, Asia-Pacific, and North America.
What is your minimum order quantity for bulk supply?
We offer flexible bulk supply options, with minimum order quantities tailored to the scale of your business. For details, contact **info@delwishealthcare.com**.
How do you ensure the viability of probiotic strains during manufacturing?
Our formulation process includes controlled moisture management and sterile processing to maintain strain viability, with potency validated through analytical testing.
Can you support contract manufacturing for probiotic products?
Yes, we provide end-to-end contract manufacturing services, including formulation development, production, and regulatory compliance support for pharmaceutical clients.
.webp&w=3840&q=75 "PB-2 Capsule")
