India APAC
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC in APAC
Pharmaceutical Intermediate and API manufacturing company. WHO GMP accredited and also hold EU Written confirmation
About the plant
The company is a pharmaceutical intermediate and API manufacturing plant incepted in 1985.
WHO-GMP Accredited and also hold EU Written confirmation
API Registered in Russia, Japan
Annual Production Capacity - 350MT
Compliance
- World Health Organization (GMP / HACCP)
Activity
- Oral solids / OSD, Topical, mucosal and transdermal, Powders, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, Intermediates, API (Active Pharmaceutical Ingredients) manufacturing
Features
- Uses: Commercial (Phase IV), Human, Veterinary
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
- Controlled substance: Low potential for abuse, Lowest potential for abuse
- BSL: N/A
- Therapeutic areas: (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system
- Markets: PMDA (Japan), CDSCO (India), Russian Health Authorities
Batch Size / Reactor
- Small, Medium, Large, 2,000 - 5,000 L
Services
- Manufacturing services, Engineering batches, Scale-up, Pilot batches, Batch records, Clean room rental, Milling
