Infrastructure > Nivedita Chemicals
Infrastructure
Anek Prayog Pvt Ltd has state of-the-art plant facilities with a robust Quality Management system (QMS). The facility is situated at Roha (in Raigad district), Maharashtra. It spreads over a total area of two acres where the built up area is about 6000 sq meters.
The API’s are manufactured, tested, packed and labelled in the cleaned environment as per the standard established procedures inlined with cGMP standards.
We operate a dedicated manufacturing block for Sodium Stearyl Fumarate having a capacity of 5MT/month, which includes a Jet-Mill facility for micronizing as per specific customer requirements.
Final Powder Processing Area (Pharmazone)
The final powder processing activities like crystallization, drying, milling, packing, and labelling of the API’s are carried out in the clean room areas (Class 100,000).
The API’s are manufactured, tested, packed and labelled in the clean environment as per the standard established procedures in-line with cGMP standards.
There are total 9 Air handling units (AHU’s) with class 100,000 in clean room area’s, 10,000 in Microbiology laboratory and once throw (Positive pressure) systems in crystallization area.
Quality Control Laboratory:
The laboratory is equipped with the sophisticated insturments like, HPLC’s GC, GC-HS, FTIR, Electronic Balances, Digital Polarimeter, UV spectrophotometers and Stability chambers.
Micorbiological Laboratory:
It is designed as per the WHO norms.
Quality Assurance:
Anek Prayog Pvt Ltd has a robust Quality Management system (QMS) in place.
Our Quality Assurance department comprises professionals, who are experienced and Well-versed with quality norms in national as well as international markets.
Research & Development Laboratory:
Our Rsearch and Development Center (situated in Mumbai) has been recognized by the “Department of Scientific and Industrial Research” (DSIR), Government of India since 1981.
We blend innovation and technology together to search and manfactures API’s that meets the expectations of our customer. Our R&D department work continuously in developing products, keeping in mind four factors, Quality, Stability, reproducibility and affordable prices. The R&D is supported by well equipped ananlytical laboratory.
Regulatory Affairs:
Our Regulatory affairs team has indepth exposure to requirements of various regulatory agencies for the registrations of API’s, Preparations of DMF, COS application, Regulatory audits and approvals, etc. We have registered Drug Master Files of our products to various authorities in Europe and also in South America, South Africa, Korea, Taiwan, Israel, Iran, and East Asia.