India APAC
FDF / DRUG PRODUCTS in APAC
APDM Pharmaceuticals is a pharmaceutical CDMO based in Ahmedabad, specializing in formulation development and contract manufacturing for regulated and semi-regulated markets.
About the plant
APDM Pharmaceuticals is a pharmaceutical CDMO based in Ahmedabad, specializing in formulation development and contract manufacturing for regulated and semi-regulated markets. The facility is designed to support oral solid dosage forms with capabilities in product development, scale-up, technology transfer, and commercial manufacturing. APDM focuses on quality-driven operations, regulatory compliance, and global business partnerships across markets such as Europe, the USA, CIS, Latin America, and domestic India.
Compliance
- ICH
- EMA (EU GMP)
- FDA (cGMP)
- Health Canada (Canada GMP)
- World Health Organization (GMP / HACCP)
- MHRA (UK GMP)
- ICHQ3A
- ICHQ3B
- ICHQ3D
- ICHQ1A
- ICHM7
Activity
- Oral solids / OSD, Tablets, Hard capsules, Granules / Pellets, FDF / DRUG PRODUCTS manufacturing
Features
- Uses: Commercial (Phase IV), Human
- 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), 4 / HPAPI (PDE = 10 - 100 µg/day)
- Controlled substance: High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse, Lowest potential for abuse
- BSL: 1, 2, 3, 4
- 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, (V04) Diagnostic agents, (V01) Allergens
- Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), FDA (USA), EMA (EU), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), EDE (UAE), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia)
Batch Size / Reactor
- Small, Medium, Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Formulation mixing, 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, Primary packaging, Secondary packaging, Labeling, Serialization, ANDA (Abbreviated New Drug Application) submission support, CTD/eCTD compilation and submission, Stability tests, Identity, Content, Purity / Potency, Impurities, Physicochemical characterization, Water content (KF), Particle size (LD), Crystal form, Residual solvents (GC-MS), Endotoxins (LAL), Microbiology
