FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC SERVICES in APAC
Synfine Drugs
About the plant
Synfine Drugs Private Limited, based in Hyderabad, India, stands as an innovative and forward-thinking pharmaceutical firm. Since our inception in 2020, we have consistently excelled as a reputable manufacturer and exporter of a wide range of Active Pharmaceutical Ingredients (APIs) and Intermediates. Our commitment to unwavering quality and strict compliance is evident through our ISO 9001:2015 certification and steadfast adherence to Good Manufacturing Practices (GMP) standards.
We take immense pride in our capacity to support our regulatory-focused customers by offering comprehensive documentation essential for Drug Master File (DMF) submissions. Recognizing the pivotal role of regulatory compliance in the pharmaceutical industry, we are devoted to guiding our clients through the intricate regulatory landscape.
Our dedication to excellence extends to our commitment to expand our product portfolio, explore new opportunities, and bolster partnerships within the pharmaceutical sector. We consistently invest in research and development to remain at the forefront of technological advancements, ensuring our customers receive cutting-edge products and services.
Synfine Drugs’ steadfast commitment to quality, compliance, affordability, and customer satisfaction establishes us as a trusted partner for pharmaceutical manufacturers worldwide. We are eager to seize the opportunity to meet your pharmaceutical needs and contribute to advancing global healthcare through our exceptional APIs and intermediates.
Certifications
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- Health Canada (Canada GMP)
- ECOVADIS
- World Health Organization (GMP / HACCP)
- ANVISA (Brazil B-GMP)
- PMDA/MHLW (Japan GMP)
- MHRA (UK GMP)
- UAE Ministry of Health & Prevention
Activity
- FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, SERVICES manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Human, Veterinary
- 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)
- DEA: Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
- BSL: 1, 2
- Therapeutic areas: (A) Digestive tract and metabolism, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (V06) Nutrients, (V04) Diagnostic agents
- Markets: COFEPRIS (Mexico), ISP (Chile), FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia)
Batch Size / Reactor
- Small, Medium, Large
Services
- Development services, Manufacturing services
