India APAC
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC SERVICES PARTICLE ENGINEERING in APAC
Dry Powder Inhalation Plant
About the plant
1. Contract Manufacturing (CDMO)
As a leading Contract Development and Manufacturing Organization (CDMO), we deliver flexible, scalable, and regulatory-compliant manufacturing solutions.
Our specialized offerings include:
- Premix Manufacturing – development and supply of high-quality premix formulations aligned with IP, BP, and global pharmacopoeial standards.
- Bulk Capsules – large-scale manufacturing of bulk capsule formulations under certified facility, ensuring consistency and compliance.
- Finished Dosage Forms (FDF) – manufactured in two options to meet diverse partner requirements:
- With Device (Drug–Device Combination Products) – integrated solutions that combine capsules with inhalation or other delivery devices, enhancing usability and patient outcomes.
- Without Device (Standalone Dosage Forms) – flexible supply of finished dosage forms ready for global markets without device integration.
Our manufacturing facilities are fully equipped to serve highly regulated markets like US and Europe, ensuring global reliability and compliance.
2. Product Development (CRO)
We support partners with end-to-end product development expertise across therapeutic categories.
Services include:
- Generic Product Development – efficient development of cost-competitive generics designed for US FDA, EU EMA, and global filings.
- Novel & Differentiated Products – innovative formulations and advanced delivery systems that offer value-added differentiation.
- Global Market Compliance – proven track record in preparing regulatory submissions for highly regulated markets worldwide.
Our R&D and formulation teams leverage strong CMC frameworks to accelerate product approvals and commercialization.
3. Technology Transfer
We ensure seamless technology transfer from R&D to full-scale commercial manufacturing, enabling rapid global market access.
- Scale-Up & Validation – reproducible, validated processes with focus on quality and efficiency.
- Regulatory Support – comprehensive technical documentation for international filings.
- Commercial Supply Integration – smooth transition into global manufacturing networks with consistent product performance.
Our structured tech transfer protocols minimize risks, reduce timelines, and guarantee compliance with international regulatory standards.
Compliance
- ICH
- ISO
- EMA (EU GMP)
- ECOVADIS
- World Health Organization (GMP / HACCP)
- Halal Research Council
- 9001
- 13485 (Medical devices)
- 14001
- 45001
- ICHQ3A
- ICHQ3B
- ICHQ3D
- ICHQ1A
- ICHM7
Activity
- Inhalation products, Oral solids / OSD, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Aerosol, Powder, Nebulization, Fill&Finish, Sprays, Semisolid forms, Liquid forms, Patches, Rectal and vaginal dosage forms, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING, API (Active Pharmaceutical Ingredients), Radiopharmaceuticals manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
- Controlled substance: N/A
- BSL: 3
- Therapeutic areas: (R) Respiratory system
- Markets: EMA (EU)
Batch Size / Reactor
- Small, Medium, Large, > 10,000 L
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, Clean room rental, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Genetic analysis & Pharmacogenetics, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission, Orphan Drug Designation Support, Salt screening, Co-crystal screening, Polymorph screening, Crystallization screening, Chiral resolution screening, Milling, OSD (Oral Solid Doses) manufacturing, Fill and finish, Safety studies, Solid form selection, Crystal engineering, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment, Customized block synthesis, Impurity synthesis, Extractables & Leachables, Stability tests, Identity, Content, Purity / Potency, Impurities, Physicochemical characterization, Water content (KF), Particle size (LD), Crystal form, Residual solvents (GC-MS), Elemental impurities / Metals (ICP-MS), Nitrosamines (HPLC-MS/MS), Endotoxins (LAL), Microbiology, Proteomics, Metabolomics, Drug Product – Liquid, Drug Product – Solid, API / Excipient – Liquid, API / Excipient – Solid
