India APAC
BIOLOGICS SERVICES in APAC
GMP-compliant biologics manufacturing facility specializing in recombinant enzymes and proteins for biopharmaceutical and peptide manufacturing applications.
About the plant
A state-of-the-art GMP manufacturing facility dedicated to the development and commercial production of recombinant enzymes and biologics. The plant supports biopharmaceutical manufacturing workflows including peptide, protein, and hormone processing.
The facility is designed to meet global regulatory expectations with robust quality systems, scalable bioprocessing infrastructure and strong analytical capabilities. Our company supports customers from early development through commercial supply with a focus on consistency, regulatory compliance and long-term partnerships.
Compliance
- ISO
- ECOVADIS
- World Health Organization (GMP / HACCP)
- Halal Research Council
- 9001
- 22000 (Food)
Activity
- Peptide, protein, hormone & enzyme, BIOLOGICS, SERVICES manufacturing
Features
- Uses: Investigational, Human
- Toxicity (OEB classification): N/A
- Controlled substance: N/A
- BSL: 1, 2, 3
- Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system
- Markets: DIGEMID (Peru), COFEPRIS (Mexico), 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, Batch, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L, 2000 - 5000 L
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, R&D, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, ICH Stability studies, Comparability studies, Downstream, Cell line development, Cell banking, Sterile product manufacturing, Non sterile product manufacturing, Upstream, Tech transfer, Lyophilization, Engineering batches, Scale-up, Pilot batches, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, Batch certification / release, GMP documentation, CMC regulatory support, IND (Investigational New Drug aplication) filing support, NDA (New Drug Application) submission support, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission
