Manufacturing Facilities
Neuland has two world-class API manufacturing facilities close to the city of Hyderabad, capable of handling complex and hazardous reactions. The manufacturing facilities comply with stringent guidelines & requirements of Good Manufacturing Practices (GMP) and are successfully inspected/approved by international health and regulatory agencies.
A few key features of the facilities include:
- More than 11 production blocks covering 2,800 to 4,500 Sq. Mts. of production area, and a mini-plant for scaling up of new products.
- Total reactor volume ranging from 151,000 to 375,000 litres.
- Capable of handling broad spectrum of reactions and wide range of process parameters.
- Facilities have been inspected by US FDA, EDQM, BfArM (Germany), TGA (Australia) and PMDA (Japan).
- TGA cGMP and WHO GMP approved and ISO 9001:2000 certified; OHSAS and ISMS Certified.
- Manufacturing base typically consists of high value and high volume facility.
- kilo-labs facility for scale up activities
These features ensure an effective structural methodology at workplace which includes manufacturing of quality products, rational and effective use of available resources, minimization of waste along with good safety and hygiene standards.
Safety aspects have been given utmost importance, in all aspects including plant installation, equipment, systems and trained personnel to ensure smooth productivity. Combination of a dedicated team and world class production techniques guarantee delivery of products to customers across the globe.
Unit-I
Bonthapally
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.
Services
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
Unit - II
Pashamylaram
Unit-II situated at Pashamylaram is about 45 kilometers from Hyderabad airport. The facilities are built in a total area of 36,800 sq.mts and consist of three main production blocks, engineering workshop and four warehouses.
Highlights of Unit-II
- Inspected by US FDA in 1999, 2002 and 2005.
- Inspected by BfArM (Germany) in 2007
- TGA cGMP and WHO GMP approved.
- High volume facility with dedicated production blocks for range of products.
- Three blocks covering 1,968 sq. mts of production area.
- Total Reactors Volume of 300,000 liters.
- Product line includes Fluoroquinlones, Anti-Ulcerants, and Prostaglandins.