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WORLD’S LARGEST cGMP API AND INTERMEDIATES MANUFACTURING FACILITY

Manufacturing Facilities

  • Divi’s operates three world-class manufacturing facilities located near Hyderabad, Visakhapatnam, and Kakinada in India.
  • Unit 2 in Visakhapatnam is well-known as the world’s largest API manufacturing facility. The third facility, near Kakinada, commenced operations in January 2025.
  • Together, the three units house 76 production buildings and 70 pharma suites, with a total reaction capacity exceeding 18,600 m³.
  • Divi’s is a commercial-scale manufacturer of APIs, capable of delivering volumes ranging from gram-scale to thousands of tons, all within strict cGMP standards across all stages.
  • With significant capacities, dedicated production blocks, and backward integration to basic starting materials, Divi’s ensures reliable supply to all global customers.
  • The pilot plants at Divi’s are capable of handling highly potent compounds (up to 10 mcg/m³ exposure levels) and several low-dosage products, under cGMP-compliant conditions.
  • Divi’s pharma areas comply with Class 100,000 cleanroom standards, and are equipped with advanced filtration and drying systems, including:

– Centrifuges
– ANFDs (Agitated Nutsche Filter Dryers)
– VTDRs (Vacuum Tray Dryers)
– RCVDs (Rotary Cone Vacuum Dryers)
– Milling and sieving equipment

Kilo Labs

  • Kilo Lab (cGMP)
  • Flexible, multi-purpose
  • Scale-up studies
  • Production of 1 kg to 10 kg batch size

Pilot Plants

  • Physical segregation and containment for processing and isolation
  • Containment systems are in place to handle the hazardous reactions
  • All pilot plants are equipped with cryogenic, high temperature and high vacuum capabilities and offer a broad range of isolation equipment

Commercial Scale

  • Multipurpose production facilities offering greater flexibility
  • Special Production blocks to handle pyrophoric, high- energy, Azide chemistry, and high Pressure reaction with fool-proof safety requirements
  • Batch sizes as large as 6 MT

Manufacturing Plants Overview

UNIT 1

  • Total Land: 500 Acres (2 sq. kms)
  • CAPACITY : ~5,700 M3

INFRASTRUCTURE:

  • Land: 500 Acres (2 sq. kms)
  • Production Blocks: 30

CAPACITY:

  • Reactors: Over 880
  • Capacity: ~ 5,700 m3

REGULATORY INSPECTIONS:

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

UNIT 2

  • Total Land: 500 Acres (2 sq. kms)
  • CAPACITY : ~11,100 M3

INFRASTRUCTURE:

  • Land: 500 Acres (2 sq. kms)
  • Production Blocks: 40

CAPACITY:

  • Reactors: Over 1,190
  • Capacity: ~ 11,100 m3

REGULATORY INSPECTIONS:

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

UNIT 3

  • Total Land: 500 Acres (2 sq. kms)
  • CAPACITY : ~1,850 M3 (Phase I)

INFRASTRUCTURE:

  • Land: 500 Acres (2 sq. kms)
  • Production Blocks: 6 (Phase I)

CAPACITY:

  • Reactors: Over 180
  • Capacity: ~1,800 M3