Unit II-Pharma Impex Laboratories Pvt.Ltd.(Baruipur Plant)
#### Pharma Impex Laboratories Pvt. Ltd. Baruipur,
is a leading fast growing professionally managed Pharmaceutical Company with operating Head Office in Park Street Kolkata, India. It has Two Manufacturing Plants.
We are pleased to introduce ours that, we set up a manufacturing unit to produce I.V.FLUIDS, situated at South Uttarbhag, Ramnagar Baruipur, Dist. 24 PGS (S)-, West Bengal, is Very Near to Kolkata. Under the name Pharma Impex Laboratories Private Limited (II Unit). The plant has been designed as per W.H.O. G.M.P. norms have certified by GMP, GLP, WHO and focus on International regulatory approvals.
The Pharma Impex Laboratories Private Limited for the manufacture of Life saving Drugs (IV Fluids) of international quality in L.D.P.E bottles using Form- Fill- Seal (FFS) technology. For the manufacturing of the I.V. Fluid bottles, the containers are formed, filled and sealed mechanically in a close sterile chamber. The Entire manufacturing facility is designed and constructed as per the Drugs and Cosmetic Act 1940 and Rules there under. The entire process is free from any type of pathogenic organisms, human contact and atmospheric exposure. The High-tech filtration system and super sophisticated terminal sterilization system renders the solution sterile and pyrogen free. The Manufacturing facilities of Company environment as per WHO GMP and revised Schedule M.
The container is preparing by using Pharmaceutical grade pure virgin LDPE granules. The Water for injection which we use having high quality through new innovative techniques like Softening, Multi grade filtration, Reverse Osmosis process, Electronic De-Mineralization and Multi Column Still. Distillation & Condensation at a temp. of 165ºC and maintaining WFI temp as above 80ºC, is circulated continuously through loop line and is free from all type of contaminations like bacteria fungus and Pyrogen. We are maintaining the quality of product by using high quality approved raw materials and filtration through 5µ, 0.45 µ and 0.22µ filters. The major process in I.V. Fluid manufacturing is Sterilization, for that we using super sophisticated Equipment which called as Super Heated Water Spray Sterilizer at validated time and temperature.
We have sophisticated in-house Laboratory for the analysis of Raw materials, Packing materials, Process materials and Finish goods. Physical, Chemical & Microbiological testing. The entire laboratory and manufacturing facility is as per the Drugs and Cosmetic Act.
#### Pharmaceutical Manufacturing Activities as Licensed by the National Drug Authority:
All the Pharmaceutical Manufacturing Activities are carried out as per WHO-GMP & Schedule–M of the Indian Drugs & Cosmetics Act. The day to day licensing and regulatory activities are controlled by Drugs Control & Licensing Authority, Drug Controller Kolkata, Food & Administration and CDSCO (Central Drug Standard Control Organization), Kolkata, East Zone –India