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Unit I – Bonthapally Manufacturing Facility

Overview

In keeping with its commitment to provide assured quality, the Unit I manufacturing facility at Bonthapally adheres to stringent guidelines and requirements of Good Manufacturing Practices (GMP) and is approved by international health and regulatory agencies such as US FDA, TGA (Australia), PMDA (Japan) and WHO.

A key feature of the manufacturing process is the supervision and the involvement of a committed team which with the help of latest production techniques and calibrated planning guarantees on-time delivery of products.

Unit I is situated at Bonthapally village in Medak District, which is approximately 65 kilometers from Hyderabad airport. It is developed on a total area of 11.2 acres and has seven production blocks including the kilo labs and other supporting departments such as Quality Assurance and Quality Control (QA & QC) and Regulatory Affairs (RA).

The facility has been inspected by the USFDA 6 times (1997, 2004, 2008, 2010, 2014, 2017) and by EDQM in 2005. The PMDA (Japan) audited and approved the facility in 2008. It is also certified by the following management systems:

  • ISO 9001 certified for its quality systems
  • ISO 14001 certified for its environment management
  • OHSAS 18001 certification for occupational health systems

Highlights of Unit I

  • Consists of small volume high-value production facility with vessels ranging from 20 liters to 3000 liters
  • Seven production blocks covering 3,875m2 of production area, kilo lab and 4 warehouses (including explosive warehouse)
  • Built up area of the plant is approximately 45,000m2
  • Total reactor volume of 222.5 KL
  • Capable of handling broad spectrum of reactions and a wide range of process parameters
  • Products manufactured include:
    Antiasthmatics, Cardiovasculars, Antifungal, Anticonvulsants, Antiemetic, Central Nervous System (CNS), Fluoroquinolones, Corticosteroids, Antipsychotic, Antibacterial and Anti-parkinson

Services

The following is an illustrative list of reactions that are handled at Neuland’s facilities on a continuous basis:

  • Bromination
  • Diazotization
  • Friedel Craft Reactions
  • Hydrogenations
  • Mannich Reactions
  • Grignard Reactions
  • Metal Hydride Reactions
  • Oxidation
  • Cryogenic Reactions
  • Hydrofluorination
  • Methylation
  • Resolution of Racemic mixtures
  • Stereo-specific synthesis
  • Micheal Addition Reaction
  • Silylation Reaction

Utility Services at Unit I

  • Cooling Water Tower: 1540 TR
  • Chilled Water: 247 TR
  • Chilled Brine: 244 TR
  • Purified water system: 2000LPH
  • Hot Water: up to 90°C
  • Steam: 8 TPH
  • Vacuum System: up to 1 Torr
  • Compressed Air: 1170 CFM
  • Captive Power Generators: 2000 KVA
  • Boiler: 8 tons