Manufacturing / Overview
In keeping with its commitment to provide assured quality, the manufacturing facility at Bonthapally (Unit I) adheres to stringent guidelines & 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-1 is situated at Bonthapally Village in Medak District which is approximately 35 kilometers from the 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 & quality control (QA&QC) and Regulatory Affairs (RA).
The facility was inspected by the US FDA in 1997 (and re-inspected in 2008), cGMP approval in 2004, EDQM approval in 2005. PMDA (Japan) has also audited and approved the facility in 2008.
The facility is 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-1
- Consists of small volume high value production facility with vessels ranging between 20 liters to 3000 liters.
- Seven production blocks covering 2,500 square meters of production area, kilo lab and 4 ware houses (including explosive warehouse).
- Built up area of the plant is approximately 45,325 sq mts.
- Total reactor volume of 100,500 liters.
- Capable of handling broad spectrum of reactions and a wide range of process parameters.
- Products manufactured include:
Anti-Asthmatics, Cardiovasculars, Anti-Fungal, Anti convulsants, Anti emetic, Central Nervous System (CNS), Fluoroquinolones, Corticosteroids, Anti Psychotic, Anti bacterial and Anti-parkinson.
Following is an illustrative list of reactions that are handled at Neuland’s facilities on a continuous basis:
- Friedel Craft Reactions
- Mannich Reactions
- Grignard Reactions
- Metal Hydride Reactions
- Cryogenic Reactions
- Resolution of Racemic mixtures
- Stereo-specific synthesis
- Micheal Addition Reaction
- Silylation Reaction