Development Process Formulation Characteristics
We invite you to begin by consulting with us for a formulation feasibility evaluation (feasibility study).
We provide high‑quality pharmaceutical products under a GMP‑compliant quality management system by leveraging our accumulated experience. We deliver safety, reliability, and a stable supply of drugs by rigorously implementing deviation and change control processes and ensuring full traceability of records.
We engage from the early stages of development, encompassing formulation and process design as well as prototype development and evaluation, and provide seamless, end‑to‑end support from investigational drug development through commercial contract manufacturing.
We can flexibly accommodate a wide range of needs, from small‑scale pilot production to stepwise scale‑up toward larger‑scale manufacturing.
We provide a one‑stop solution offering seamless support from development through commercial manufacturing.
Please contact us to see how we can assist you.
Consultation
We will enter into a confidentiality agreement (NDA) if necessary and discuss your challenges and requirements in detail.
Development Planning
Based on your requirements and current development status, we carefully assess all aspects and propose the most appropriate development plan and timeline.
Formulation Feasibility Study
We perform a formulation study based on a strategic plan - including excipient screening and preliminary stability assessments - and carry out capsule prototyping using encapsulation equipment.
Pre-formulation (Active Pharmaceutical Ingredient)
Formulation Design (Fill Material and Shell)
Encapsulation Feasibility Study
Investigational Drug Manufacturing
We provide comprehensive support across all stages from investigational drug manufacturing through commercial production.
Phase I
Phase IIa
Phase IIb
Phase III
Commercial Production
We maintain a stable supply supported by reliable technical capabilities and an excellent quality assurance framework.
※The scope of evaluations, required API quantities, manufacturing scale, and lead times shown are examples only and may vary depending on circumstances.
API Properties Suitable for Softgel Capsule Formulations
Low solubility APIs
Solution/dispersion filling
Lipid soluble APIs
Oil-based formulation design
High-potency APIs (HPAPI)
Sealed containment system
Bitter-tasting and odorous APIs
Masking
Oxidation-sensitive APIs
Oxidative protection
Softgel formulations are an effective dosage form for APIs exhibiting the following characteristics.
01 Formulation Flexibility
This dosage form enables the encapsulation of a wide range of fill formulations including solutions and suspensions.
Depending on the formulation design, both the composition of the fill material and the capsule shape and size can be selected.
02 Dissolution/Absorption Properties
The API can be encapsulated in a dissolved or finely dispersed form by employing solubilization and dispersion strategies.
Enhanced dissolution and absorption are anticipated in the case of poorly soluble APIs.
03 High-potency API Containment
The API can be filled in a dissolved or dispersed state in a liquid and then sealed with a capsule shell.
This helps reduce the risk of API dispersion and operator exposure during the formulation process.
04 Product Quality Stability
The capsule shell provides protection against external environmental influences, helping to prevent quality deterioration such as oxidation.
Light protection can also be achieved by optimizing the shell composition.
05 Content Uniformity
This dosage form offers superior content uniformity compared with solid tablets as the formulation is filled in liquid form.
It also has the advantage of minimal scale‑up impact during manufacturing.
06 Masking Effects
The capsule shell masks the bitterness and odor of the API, helping to improve palatability and reduce discomfort upon administration.
Track Record in Pharmaceutical Manufacturing
20Years
※33 years since establishment
Utilizing expertise built over many years, we deliver
consistently high‑quality products with stable manufacturing performance.
(Authorized Pharmaceutical Manufacturer – May 2006）
Major Quality Complaints (past 20 years)
Regulatory Inspection Observations (past 3 years)
0Complaints/Observations
By implementing thorough quality and delivery control, we provide a stable supply while maintaining the flexibility to meet customer requirements.
Dosage Forms Manufactured
3Types
・Softgel CapsulesWe are among few companies in the industry specializing in softgel capsules and also hold a proprietary formulation technology, “UniORV®”
We strive to contribute to the mental and physical well-being of people around the world through the development and manufacture of pharmaceutical products. We produce high-quality pharmaceutical seamless capsules using proprietary manufacturing equipment developed in-house. All capsules undergo 100% inspection using state-of-the-art automated inspection systems, and our fully automated packaging lines enable integrated production from stick packaging through to final packaging. Our manufacturing staff are trained in pharmaceutical GMP and thoroughly familiar with SOPs (Standard Operating Procedures).
The Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Drugs and Quasi-Drugs (GMP), which establishes standards to ensure consistent safety and high quality in the manufacture of pharmaceuticals, is based on the following “Three Principles of GMP”.
・Minimize the risk of human error
・Prevent contamination and deterioration of drug quality
・Design a system to ensure high quality
All products are manufactured in compliance with pharmaceutical GMP under rigorous quality control standards.
