Manufacturing Facilities

World’s largest cGMP API and Intermediates manufacturing facility.

MANUFACTURING FACILITIES

World’s largest cGMP API and Intermediates manufacturing facility.

Divi’s currently operates two manufacturing sites near Hyderabad and Visakhapatnam in India. A third manufacturing site is proposed to be set up near Kakinada, India in 2019.
Both the manufacturing units have more than 35 production buildings and 50 pharma suits with a total reaction capacity of more than ~12000m3, making it one of the largest API manufacturing facilities in the world.
The pilot plants at Divi’s are capable of handling high potent products (Products with exposure level up to 10mcg/m3) and several low dose products under cGMP.
Divis is Commercial-scale manufacturer of non-potent & highly potent APIs to deliver from gram scale to 1000’s of tons under cGMP.
Divi’s pharma areas comply with class 100, 000 clean air requirement and each pharma will have suitable filtration and drying equipment like centrifuge, ANFD, VTDR, RCVD, milling and sieving equipment’s.

KILO LABS

  • 2 Semi Automated cGMP kilo labs
  • 14 jacketed reactors from 10Lts to 100Lts from De-Dietrich
  • Scale: Up to 10Kgs

PILOT PLANTS

  • 3 cGMP Pilot plants with 12 Pharma suites
  • 80 Reactors from 250Lts to 3000Lts + 70 Reactors newly commissioned
  • USFDA Inspected
  • Scale: 10 to 100 Kgs

COMMERCIAL SCALE

  • 35 multipurpose blocks with 50 pharma suites
  • 1728 reactors ranging from 2000Lts to 3000Lts
  • US FDA Inspected
  • Scale: 10’s of tons to 1000’S of tons

Manufacturing Plants Overview

UNIT-1

Total Land: 500 Acres (2 sq. kms)
CAPACITY : ~2000m3

Manufacturing Facility Near Hyderabad

INFRASTRUCTURE:

  • Land : 500 Acres (2 sq. kms)
  • Buildings : 13

CAPACITY:

  • Reactors : Over 400
  • Capacity: ~ 2000 m3

REGULATORY INSPECTIONS:

  • USFDA
  • EU GMP
  • JAPAN PMDA
  • MFDS(K FDA)
  • COFEPRIS

UNIT-II

Total Land: 450 Acres (1.8 sq. kms)
CAPACITY : ~8000m3

Manufacturing Facility Near Visakhapatnam

INFRASTRUCTURE:

  • Land : 450 Acres (1.8 sq. kms)
  • Buildings : 22

CAPACITY:

  • Reactors : Over 850
  • Capacity: ~ 8000 m3

REGULATORY INSPECTIONS:

  • USFDA
  • MHRA (UK)
  • JAPAN PMDA
  • MFDS(Koriea FDA)
  • COFEPRIS
  • TGA (Australia)

UNIT-III

Total Land:  425 Acres (1.2 sq. kms) 
CAPACITY  : Construction  under progress

Manufacturing Facility Near Kakinada (Under progress)

2019:

Setting up of Unit – III Manufacturing Site at Kakinada