Integrated Pharmaceutical Solutions
From concept to commercial scale, Nishcura Healthcare delivers manufacturing and R&D services built on scientific rigor and regulatory compliance.
Block 01
Manufacturing Services
Solid Oral Dosage Forms
Comprehensive manufacturing capabilities for tablets (immediate, sustained, and modified release), capsules (hard gelatin and HPMC), and granules/sachets. Our compression and coating suites operate under controlled environmental conditions compliant with WHO-GMP requirements.
Oral Liquid Preparations
Manufacture of syrups, suspensions, emulsions, and oral solutions in various pack formats. Our liquid manufacturing area is equipped with inline mixing systems and automated filling lines, ensuring batch-to-batch consistency and microbial integrity.
External Preparations
Manufacturing of topical formulations including creams, ointments, gels, and lotions. Produced under controlled temperature and humidity conditions with emphasis on microbial control and physicochemical stability.
Parenterals (Injectables)
Sterile manufacturing of small-volume parenterals including vials and ampoules. Our parenteral unit meets ISO clean room classifications with HEPA filtration, pressure cascade management, and validated sterilization processes.
Block 02
Research & Development Services
Analytical Research & Development (ARD)
Our ARD unit specializes in the development and validation of analytical methods for both active pharmaceutical ingredients and finished formulations. We follow ICH Q2(R1) guidelines for method validation, ensuring accuracy, precision, specificity, linearity, and robustness.
- HPLC Method Development
- UV-Vis Spectrophotometry
- Method Validation (ICH Q2)
- Impurity Profiling
- Dissolution Method Development
Formulation Research & Development (FRD)
Our FRD team develops novel and generic pharmaceutical formulations with a focus on bioavailability optimization, patient compliance, and regulatory acceptability. We leverage QbD principles for robust formulation design.
- Generic Drug Development
- Formulation Optimization (QbD)
- Excipient Compatibility Studies
- Prototype Development
- Feasibility Studies
Stability Studies
ICH Q1A(R2) compliant stability studies conducted under accelerated, intermediate, and long-term conditions. Our stability chambers are qualified and continuously monitored to ensure data integrity and regulatory compliance.
- ICH Q1A Accelerated Studies
- Real-Time Long-Term Studies
- Stress Testing (Photostability)
- Shelf-Life Determination
- Stability Data Reporting
Method Development
Comprehensive analytical method development services for API characterization, dissolution profiling, assay, and impurity determination across multiple dosage forms and therapeutic categories.
- RP-HPLC Development
- Dissolution Method Finalization
- Cleaning Validation Methods
- Microbiological Methods
- Pharmacopeial Methods
Scale-Up Studies
Systematic scale-up from lab to pilot to commercial scale, with process characterization, critical process parameter identification, and process validation to support regulatory filings.
- Lab to Pilot Scale-Up
- Process Characterization
- Process Validation (PV)
- Critical Quality Attributes
- Batch Record Development
Technology Transfer
Structured and documented technology transfer programs ensuring successful and compliant transfer of product knowledge, analytical methods, and manufacturing processes between sites.
- Product Knowledge Transfer
- Analytical Method Transfer
- Comparative Testing Studies
- Site Transfer Protocols
- Post-Transfer Validation
Looking for a Manufacturing or R&D Partner?
Contact our team to discuss your project requirements, timelines, and how Nishcura Healthcare can support your pharmaceutical objectives.
Request a Consultation