Nifty

Profile

Nifty Labs Pvt. Ltd. was founded in March 2005. The company has been manufacturing Active Pharmaceutical Ingredients (APIs) and advanced Intermediates for APIs. "Nifty" is promoted by technocrats, having more than 20 years of experience in Bulk Drug substances manufacturing.

"Nifty" manufacturing facilities are State-of-the-art & GMP compliant. The API manufacturing facility is located at IDA, Kondapally which is about 15 km away from Vijayawada a historical town and 250 km away from Hyderabad, Andhra Pradesh, India. The manufacturing premise is about a total area of 1.4 hectare with a constructed plinth area of about 7800.00 m2.

The facility has 3 independent production blocks with RCC constructions, installed with Process equipments which include GLR/SS316 reactors with operational capacities 0.5KL to 5.0KL volume. The production equipments does able to perform various critical reactions like Hydrogenation, Oxidation, Halogenations, Nitration and Acetylation etc., but not limited to.

The facility does have two streams of Pharma areas/clean rooms which does meet GMP and Q7 ICH quality guidance. The layout and design of the facility is qualified for handling of materials and manufacturing operations in a unidirectional flow. The facility does meet all the statutory requirements of India & rest of the globe. "Nifty" manufacture, supply APIs and advanced Intermediates for both Domestic as well as International markets. Nifty is an "Approved Vendor" for many pharmaceutical companies in India and Abroad for the DMF Products.

Nifty's mission is to become a Research-driven pharmaceutical company with a dynamic vision set by the apex management. Nifty is driven by its vision to achieve significant business growth by 2013-14 with a strong presence in Regulated & Semi Regulated markets. Nifty's aim is to provide the best in class products with a focus on customer's delightfulness. Nifty continues to reinforce its position to become a major strategic partner in its area of expertise by creating exceptional value for its customers.

Nifty, reached a business turnover of about $ 22 million in the financial year 2012-13. Nifty's business philosophy is to deliver value added services to its customers by supplying the products with cost competitive price, regulatory support & documentation support in time, to meet their demands.

Driven by passion, with its 250 skilled multi cultural workforce, Nifty continues to aggressively pursue its mission 'To become a Research-driven Pharmaceutical Company' to enable strong customer support with all available resources.

Nifty's quality control Laboratory is GLP compliant & comprises of two sections i.e wet analysis lab and an instrumentation lab which does have analytical instruments like UV-VIS spectro photo meter, FTIR, GC- Headspace, HPLCs with VWD, PDA, RI detectors, Potentiometric Titrator, Digital Polarimeter, coulometer, IR moisture analyzer for routine analysis and walk-in stability chambers, stand alone stability chambers to conduct stability studies of APIs & Intermediates commercially sold in the market. Microbiology section is under commission. The lab is staffed with trained & qualified analysts to analyze the products in accordance with GLP and GMP.

Nifty has developed and validated the analytical methods for in-process tests (Reaction monitoring) non-Pharmacopeia products and advanced intermediates for APIs. Compendial methods suitability is verified before use in the laboratory.

As a part of corporate governance "Nifty" has framed policies to ensure the occupational safety & health of the personnel besides the policy for Quality. The policies are prescribed, percolated to all the employees to ensure the compliance. As a corporate citizen "Nifty" has triggered welfare programs for the personnel & the people residing in near around villages.

Nifty has obtained certifications from drug regulatory authorities, Govt. of India & Certifications from the International bodies for quality management & Environmental Management. The certifications does include WHO-GMP certificate issued by Central Drug standards control organization and ISO 9001:2008 for QMS, ISO 14001 : 2004 for EMS from the "DET NORSKE VERITAS" (DNV), Netherlands.

Off late, Nifty has received a Certificate of suitability "RO-CEP 2010-297-Rev 00" for an Antulcerative molecule "Lansoprazole Ph. Eur." from EDQM .Other molecules dossier submission work is in progress for CEP obtainment. Drug Master Files (DMFs) are available in CTD for majority of APIs and selected advanced intermediates. The DMFs/Registration applications are filed at SFDA, PMDA & KFDA.

New project expansion is in progress for commissioning of new blocks to meet the growing demands from the markets and to create spare capacity of production.