Premix, Bulk Capsules & Combo Pack with Device
We manufacture finished drug-device combination products optimized for regulatory approval, manufacturability, and patient usability. Our services include device selection for single-dose or multi-dose DPIs, formulation-device compatibility studies, prototype production for human factors testing, robust manufacturing process design, final packaging, label artwork, serialization, and lot release testing. We validate delivered dose uniformity across inhalation profiles and handset orientations, and prepare comprehensive CMC packages, stability data, and risk assessments for global submissions. Child-resistant options, tamper-evident seals, and serialization ensure supply chain integrity, while post-market monitoring supports continuous quality improvement and product lifecycle management. We support global distribution and regulatory filings across markets.
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What services does Vamsipharma provide?
Vamsipharma offers end-to-end CDMO and CRO solutions for inhalation drug development, specializing in Dry Powder Inhalers (DPI), premix formulations, and finished dosage forms. Our services include formulation development, device compatibility studies, analytical method development and validation, manufacturing technology, technology transfer, regulatory support, and commercialization assistance.
What types of inhalation devices do you work with?
We work with single-dose and multi-dose Dry Powder Inhalers, including capsule-based and reservoir systems. Our team ensures device selection is based on performance, patient usability, and regulatory requirements.
Do you offer analytical method development?
Yes. We develop and validate robust analytical methods specific to inhalation products, including APSD (aerodynamic particle size distribution), delivered dose uniformity, emitted dose, fine particle fraction, and stability-indicating assays following ICH guidelines.
Can you handle both clinical and commercial manufacturing?
Absolutely. We support projects from early clinical batches to full commercial production, with validated processes, scalable capacity, and GMP-compliant facilities for global supply.
What makes Vamsipharma different from other CDMOs?
Our inhalation-first focus, fully integrated capabilities under one roof, strong technical team, and proven track record in DPI development set us apart. We minimize handoffs, shorten timelines, and deliver regulatory-ready packages with consistent quality.
Do you provide technology transfer services?
Yes. We offer structured, low-risk technology transfer including process documentation, analytical method packages, training, validation runs, and regulatory support to ensure seamless replication of quality and performance across facilities.
How can I start a project with Vamsipharma?
Simply contact us through our website, email, or phone. Our team will discuss your project requirements, review technical feasibility, and prepare a customized development and manufacturing plan aligned with your timelines and goals.
