India APAC
CHEMICAL-SYNTHETIC API PROCESSING in APAC
An API and Interemediate manufacturer having global certifications.
About the plant
An API and Intermediate manufacturing unit based in South India with the nearest ports of Chennai and Bengaluru. The facility has a combined capacity of 200KL with all types of reaction handling capabilities and supported by all required utilities.
The Manufacturing facility is ISO 9001 certified and has been approved by PMDA, EUGMP and USFDA.
Certifications
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- World Health Organization (GMP / HACCP)
- PMDA/MHLW (Japan GMP)
Activity
- CHEMICAL-SYNTHETIC, API PROCESSING, Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients), Building Blocks manufacturing
Features
- Uses: Commercial (Phase IV), Human
- Toxicity (OEB classification): 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
- DEA: Schedule I (high potential for abuse / no medical use), Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
- BSL: 3, 4
- Therapeutic areas: (C) Cardiovascular system, (G) Genito urinary system and sex hormones, (S) Sensory organs
- Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), TGA (Australia), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities
Batch Size / Reactor
- Small, Medium, Large, 1 - 10 L, 10-100 L, 100 - 1,000 L, 1,000 - 2,000 L, 2,000 - 5,000 L, 5,000 - 10,000 L, > 10,000 L
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Process development, Process optimization, Process validation, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, 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, Analytical methods transfer, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Storage, DMF (Drug Master File) preparation and submission, Milling, Customized block synthesis, Impurity synthesis
