Shilpa Medicare Ltd., Unit - IV
This world class Finished Dosage Manufacturing facility is located in Telangana State Industrial Infrastructure Corporation (TSIIC), Pharma SEZ (Special Economic Zone); which is about 80KM from Hyderabad City and about 60KM from Ragiv Gandhi International Airport. Total area of land is 14 acres with construction area in 6 acres, 8 acres is available for future expansions and scalability.
The facility is designed for Contract manufacturing and dosage developments of potent Products (including Oncology products) for various regulatory markets. The facility is approved by USFDA, EUGMP, ANVISA, & COFEPRIS. This facility consists of Oral solid block with two commercial scale tablet manufacturing and one commercial scale capsule manufacturing line approved by USFDA. Separate Injectable blocks consists of two liquid-lyophilization commercial scale manufacturing lines approved by USFDA and 3rd Injectable combi-line for handling of liquid, lyophilized and Dry Powder Injectable under commissioning.”
Facility Regulatory Approvals:
Authority / Agency | Status | Scope |
---|---|---|
USFDA | APPROVED | OSD & INJECTION |
EU GMP | APPROVED | OSD & INJECTION |
ANVISA (Brazil) | APPROVED | INJECTION |
COFEPRIS (Mexico) | APPROVED | INJECTION |
DIGEMID (PERU) | APPROVED | INJECTION |