Agno Pharma

Production line focusing on high-potency APIs (HPAPI) with batch sizes from hundreds of grams to 25 kilograms adhering to OEB 4 and OEB 5 standards.

Production line designed for cytotoxic APIs handling batch sizes from hundreds of grams up to 12.5 Kg under OEB 4 and OEB 5 guidelines.

Production line catering to both APIs and excipients with batch sizes from hundreds of grams to 25 Kg, complying with <=OEB 3 conditions.

Flexible and customer-centric commercial drug product manufacturing services utilizing 3,000 sq. ft. of cleanroom space, advanced aseptic fill/finish capabilities, and a commercial lyophilizer.

Commercial API manufacturing and scale-up services from kilograms to tons backed by successful regulatory inspections.

Custom synthesis, development, and manufacturing of intermediates, regulatory starting materials (RSMs), active pharmaceutical ingredients (APIs), high potency APIs (HPAPIs), and sterile APIs supporting pre-clinical, clinical, and commercial requirements.

A robust 27-acre hub for cGMP manufacturing of pharmaceutical products including RSMs, intermediates, APIs, HPAPIs, and sterile APIs, specializing in custom new chemical entities and hard-to-source generic APIs.

Comprehensive CDMO services offering formulations for all routes of parenteral administration, including intravenous, subcutaneous, intramuscular, and implantable dosage forms.

Critical API development solutions spanning from preclinical to commercial production.

Formulation development and manufacturing services specializing in poorly soluble and highly potent compounds in both sterile and non-sterile environments.

cGMP-compliant particle size reduction process for APIs and excipients, ensuring efficacy and safety for high-potency and sterile applications.

Comprehensive development services for patient-centric dosage forms using bioerodible and biodurable polymers, supporting sustained drug release, enhanced targeted delivery, and improved patient adherence.

Comprehensive cGMP injectable finished dose services including aseptic liquid fill, aseptic nanomilling, lyophilization, and terminal sterilization.

A semi-continuous cryomilling process and service developed to support the development and cGMP programs of long-acting implantable systems using engineered polymers.

High-potency active pharmaceutical ingredient manufacturing services.

Advanced extrusion and amorphous solid dispersion development services for addressing complex formulation challenges, enhancing drug solubility, and achieving controlled or sustained drug release profiles.

Pre-clinical drug product test article manufacturing services suitable to support GLP studies, encompassing R&D, engineering, formulation development, and analytical support.

Particle size reduction and particulate engineering services including dry micronization, jet milling, and high-energy wet nanomilling for non-sterile and sterile active pharmaceutical ingredients.

Solvent-based manufacturing services for the development and cGMP manufacturing of long-acting implantables utilizing aqueous or organic solvent processes.

Comprehensive synthetic route scouting, design, and process development services covering the entire pharmaceutical lifecycle from initial concept through commercial stages.

Drug implant development and manufacturing for various non-ophthalmic routes of administration.

cGMP manufacturing services for sterile active pharmaceutical ingredients and sterile excipients.

Process research and development facility providing route scouting, safety evaluation, process optimization, flow chemistry, biotransformation, and kilogram-scale production of starting materials, intermediates, and APIs.

A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.

Initial Good Laboratory Practice (GLP) batches for preclinical evaluation delivered with synthetic route development and optimization for efficiency and quality.

Agno Pharma provides formulation development and CDMO services for complex oral solid and liquid dosage forms, employing techniques to increase bioavailability or achieve controlled release.

Comprehensive cGMP Regulatory Starting Materials (RSM) and pharmaceutical chemical intermediates manufacturing services, including process development, impurity identification, and stability studies.

High potency active pharmaceutical ingredients including carmustine and paclitaxel.

Ophthalmic drug implant development and manufacturing services.

Drug delivery film formulation and cGMP manufacturing.

Non-high potency active pharmaceutical ingredients including cannabidiol (CBD), cefiderocol, ceftolozane, indomethacin, sulindac, and isosulfan Blue.

Comprehensive analytical method development and validation services encompassing phase-appropriate intermediate and API characterization, complex formulation testing, and method validation packages.

Agno Pharma provides comprehensive injection molding services for processing thermoplastic and thermoset pharmaceuticals, specializing in complex shapes and structures for drug delivery systems such as implants and vaginal rings.

Service providing dissolution and recrystallization for cytotoxic API production.

Pharmaceutical development and manufacturing service.

Long-acting vaginal ring drug delivery system formulation and cGMP manufacturing.

Specialized tubing delivery system formulation and manufacturing services.

Comprehensive ICH-compliant stability testing and storage programs provided by Agno Pharma for APIs and drug products to support global development programs and regulatory submissions.

Vaginal pessary drug product formulation and manufacturing services.

Sterile filtration and drying services for pharmaceutical products.

Specialized cleaning and sterilization services for pharmaceutical packaging materials.