India APAC
CHEMICAL-SYNTHETIC COSMETICS NUTRACEUTICALS SERVICES in APAC
Small molecule drug substance development and manufacturing site
Certifications
- EMA (EU GMP)
- FDA (cGMP)
- MFDS/KFDA (Republic of Korea GMP)
Activity
- CHEMICAL-SYNTHETIC, COSMETICS, NUTRACEUTICALS, SERVICES, RSM (Raw Starting Materials), Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients), Excipients, Radiopharmaceuticals, Building Blocks, Solid or compact powder, Liquid manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
- Toxicity (OEB classification): 4 / HPAPI (PDE = 10 - 100 µg/day)
- DEA: N/A
- BSL: N/A
- Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V09-10) Radiopharmaceuticals, (V06) Nutrients, (V04) Diagnostic agents, (V01) Allergens
- Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK), MFDS (South Korea)
Batch Size / Reactor
- Small, Medium, Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Preformulation studies, Clean room rental, R&D, Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, Lyophilization, Research batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Analytical methods transfer, Batch certification / release, GMP documentation, Parametric release, CMC regulatory support, IND (Investigational New Drug aplication) filing support, NDA (New Drug Application) submission support, DMF (Drug Master File) preparation and submission, Orphan Drug Designation Support, Salt screening, Co-crystal screening, Polymorph screening, Crystallization screening, Chiral resolution screening, Milling, Safety studies, Solid form selection, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment, Customized block synthesis, Impurity synthesis
