Details


NIVEDITA CHEMICALS PVT. LTD

Description:

RESEARCH & DEVELOPMENT LABORATORY:

Our Research and Development Center (situated in Mumbai) has been recognized by the "Department of Scientific and Industrial Research" (DSIR), Government of India since 1981. The R&D is supported by well equipped analytical laboratory.We blend innovation and technology together to research and manufacture products that meet the expectations of our customers. Our R&D department works continuously in developing products keeping in mind four factors - Quality, Stability, Reproducibility, and Affordable Prices.

OTHER HIGHLIGHTS
  • Our R&D team has an in-depth understanding of cGMP, safety, and other regulatory guidelines
  • We follow processes, which minimize the hazards on the environment and ensure workplace safety
  • We are consistently on a mission to develop new drugs
We put maximum efforts to reduce the impurity level of our products, at times much more stringent than the acceptable standards mentioned inPharmacopoeias.

MANUFACTURING UNIT

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 APIs are manufactured, tested, packed and labelled in the clean environment as per the standard established procedures inline with cGMP standardsThe facility is equipped with highly technologically advanced machineries such as:
  • SS and glass lined reactors
  • Centrifuges
  • Rotocone vacuum dryer
  • Fluid bed dryer
  • PTFE lining sparkler filter
  • Tray dryer
  • Sifter
  • DM water unit
  • Chilling Plant
  • High vacuum distillation Unit
  • Boilers
FINAL POWDER PROCESSING AREA (PHARMAZONE):
The final powder processing activities like crystallization, drying, milling, packing, and labelling of the APIs are carried out in the clean room areas (Class 100,000). The APIs are manufactured, tested, packed and labelled in the clean environment as per the standard established procedures in-line with cGMP standards.

QUALITY CONTROL LABORATORY:
The laboratory is equipped with the sophisticated insturments like, HPLCs 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.

REGULATORY AFFAIRS:
Our Regulatory affairs team has indepth exposure to requirements of various regulatory agencies for the registrations of APIs, 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.
Address: A-14, MIDC, Andheri (East) Mumbai-400 093.
City:
Mumbai
Country->Province:
IndiaMaharashtra
Established in:
1972
Contact Name:
Dr. Vivekanand Palkar
Mobile:
Business Phone:
+91 - 22 - 2832 7321
Fax:
+91 - 22 - 2836 4256
Website:
www.niveditanek.com
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