Nifty is overseen by highly skilled technocrats extremely well versed in manufacturing bulk drug substances.
The API manufacturing facility is located at IDA, Kondapally, about 15 kilometers away from the historical town of Vijayawada, and 250 kilometers from Hyderabad, Telangana, India. The manufacturing premises occupy a total land area of 1.4 hectares with a constructed plinth area of about 7,800 sq. m.
The facility boasts four (4) independent production blocks housing RCC constructions and installed with process equipment that includes GLR/SS316 reactors with operational capacities of 0.1KL to 7.0KL in volume. This technology performs various critical reactions like hydrogenation, oxidation, halogenation, nitration and acetylation, among others.
The facility offers two streams of pharma areas/clean rooms which meet GMP and Q7 ICH quality guidance. The layout and design of the facility is approved for the handling of materials and for manufacturing operations in a unidirectional flow. The facility meets all national and international statutory requirements. Nifty manufactures and supplies APIs and Advanced Intermediates for both domestic and international markets. Nifty is an approved vendor for many pharmaceutical companies in India and abroad for DMF products.
Nifty’s mission is to become a research-driven pharmaceutical company with a dynamic vision set by our passionate management team. Nifty is driven by its vision to achieve significant business growth with a strong presence in regulated and semi-regulated markets. Nifty’s aim is to provide best-in-class products that reinforce its position as a major strategic partner creating exceptional value for its customers.
Nifty supplies products with cost-competitive pricing, regulatory support, and documentation support to meet consumer demand. Driven by the passion of its skilled multi-cultural workforce, Nifty continues to aggressively pursue its mission to become a research-driven pharmaceutical company with top resources and customer support
Nifty’s quality control Laboratory is GLP-compliant and comprised of two sections: a wet analysis lab and an instrumentation lab with analytical instruments like the UV-VIS spectrophotometer, 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. The facility also features a standalone stability chamber to conduct stability studies of APIs & Intermediates commercially sold in the market. The microbiology laboratory is facilitated with ISO Class-5, Class-7 & Class-8 area’s with ‘Incubators, Autoclave & Bio-Safety Cabinet’ in order to analyze TAMC, TYMC, Specific Micro-Organism for Product and Purified water and have capacity of TOC testing. Our lab is staffed with trained and qualified analysts to oversee products in accordance with GLP and GMP standards.
Nifty has developed and validated the analytical methods for in-process tests (reaction monitoring) of non-pharmacopeia products and advanced intermediates for APIs. Compendial method suitability is verified before use in the laboratory.
As part of corporate governance, Nifty has instituted policies that ensure the occupational safety and health of all personnel. The policies are prescribed and reiterated to all employees to ensure ongoing compliance. As a philanthropic corporate entity, Nifty has helped inaugurate welfare programs for personnel and citizens residing in nearby villages.
Nifty has obtained certifications from drug regulatory authorities, the Government of India, and certifications from international bodies for quality management and environmental management. These certifications include WHO-GMP certificate issued by Central Drug Standards Control Organization (CDSCO) and ISO 9001:2015 for QMS, ISO 14001 : 2015 for EMS from the “DET NORSKE VERITAS” (DNV), United Kingdom.
Additionally, Nifty has received CEP i.e., certificate of suitability from EDQM for its various products like Lansoprazole, Rabeprazole Sodium, Aripiprazole, Quetiapine Fumarate, Esomeprazole Magnesium Trihydrate and many others are in pipeline. Drug Master Files (DMFs) are available in CTD for the majority of APIs and select advanced intermediates. The DMFs/Registration applications are filed at SFDA, PMDA & KFDA.
- Mr. D. Kesava Reddy – Managing Director
- Dr. M. Sreenivasa Reddy – Director
- Mr. B. Krishna Reddy – Director, Plant Operations
- Mr. Y. Bharath Reddy – Director, Marketing