Sanali Info Park, ‘A’ Block, Ground Floor,
8-2-120/113, Road No. 2, Banjara Hills,
Hyderabad, 500034, Telangana, India
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 and requirements of Good Manufacturing Practices (GMP) and are successfully inspected/approved by international health and regulatory agencies
- More than seven 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.
Research & Development:
Neuland has a separate, specially equipped R&D Centre located at Bonthapally. We have a dedicated team of scientists working to bring complex molecules with efficient processes to market; develop non-infringing processes; develop cost effective routes; reduce impurities levels by better process understanding; and reduce effluent generation. Our R&D Centre, along with a Pilot Plant and Kilo Lab, has proven its capabilities in carrying out a wide range of reactions.
Custom Synthesis is another area where Neuland has been concentrating and is taking up several projects. We work in close association with clients, under strict confidentiality, to bring products early to markets. Under custom synthesis, we offer services and technology to meet customer requirements through established and proven synthesis routes, analytical backup at all stages of the process, etc.
We have approximately 200 experienced, qualified scientists working in R&D (over 30 with PhDs and many more Post-graduates).
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
Neuland is committed to manufacturing products in total compliance with regulatory requirements and customer expectations. All process and manufacturing operations are in accordance with cGMP requirements, US FDA and ICH guidelines and regulations.
Neuland’s manufacturing facilities at Bonthapalli and Pashamylaram have been inspected by the US FDA and also hold GMP approval from several regulatory authorities. Neuland’s Pashamylaram facility received GMP certificate from German Health authority in June 2007 and the Bonthapally facility has been successfully audited by PMDA (Japan) in October 2008.
Neuland with 33 USDMFs, 15 Canadian DMFs, 9 DMFs in Australia, 3 DMFs in Japan and 363 DMFs in various European and other regulatory markets has an unrelenting commitment and continues to be a preferred source worldwide. Neuland is accredited with CoS from EDQM for 13 of its APIs across five therapeutic categories.
The Company supports the customers with complete documentation including Drug Master Files for their dosage form applications/ANDA filings.
SAP ERP for effective information transfer across functions while ensuring high security standards. SAP
Web -based intranet application developed in-house used for key business processes that have infused transparency, speedier communication as well as robust review mechanisms.
Online meetings conducted using CISCO Webex
Lotus Domino messaging system
Connectivity between locations is on MPLS-IP VPN
Secured connectivity for accessing Intranet applications
At Neuland, we are aware that all our assets generate confidential information and therefore information security is viewed with great importance.
Neuland appreciates the importance of intellectual property rights and has put in place procedures to protect strictly intellectual properties. Neuland has initiated steps to institutionalize risk management
We have taken initiatives in the following fronts:
- Initiated steps to institutionalize risk management
- Employees trained through orientation programmes, refresher training programmes on ISMS standards on a regular basis.
- Neuland signs Confidentiality Disclosure agreements with all its customers, employees, suppliers and consultants.
- Neuland is certified for ISO 27001: 2013 standard (As of July 2015)
Neuland is a professionally managed company where the people working here make all the difference. They have the excitement, energy, commitment and sense of purpose to deliver what the customer wants. We are a customer centric organisation where there is no place for bias on the basis of race, gender, faith and place of origin.
The Company provides an environment that helps individuals to showcase their talents and rewards performance and results. This challenging workplace has helped Neuland attract, develop and retain talent, and we have done this successfully for over 30 years.
Neuland is committed to its stakeholders for their sustainable and long-term enrichment. Investor Relations is a top priority and we aim to meet all expectations with timely and reliable information.
Api s Production:
The Company’s core business and operational expertise for over 30 years since inception has been the manufacturing of Active Pharmaceutical Ingredients (APIs). Neuland has earned the identity of a preferred and reliable source in the pharmaceutical industry primarily due to:
- Consistency in product quality
- Knowledge and ability to deal with niche chemistry
- On-time delivery performance
Neuland has 2 US FDA and EU GMP compliant manufacturing facilities with collective capacity of 480 KL to produce more than 75 APIs across 10 diverse therapeutic areas.
The Company’s strengths in synthetic chemistry, process development, controlled supply chain and project management approach, built into all our operations and product development programs makes Neuland an ideal API partner for generics.