Bionext Pharma Pvt. LtdBionext Pharma Pvt. LtdPlot No C-373, T.T.C Industrial Area, Pawane, Plot No C-373, T.T.C Industrial Area, Pawane,

Navi Mumbai 400 705, Maharashtra, INDIANavi Mumbai 400 705, Maharashtra, INDIA

Quality Policy Quality Policy A clear, written down Quality Policy which projects the company's vision and the management's commitment to

Quality, the compliance to standards going beyond customer satisfaction to customer delight and achieving the Quality objective through its infrastructure and work practices is in place . Bionext Pharma Pvt. Ltd., a manufacturing

facility for Liquid Orals is Pledged To Ethics for

manufacturing of quality drug products that consistently meet

the laid down standards by adhering to current Good Manufacturing Practices (cGMP) in its facility, endeavors to delight the Customers through

its unique and cost effective formulations and timely

quality services” .

Location Location

Situated in a Pollution free zone of T.T.C Industrial area of

Navi Mumbai in PAWANE MIDC

AT A DISTANCE OF :

2 Kms from Mumbai – Pune National Highway

25 Kms from Mumbai International Airport

20 Kms from Jawaharlal Nehru Port Trust (JNPT)

10 Kms from Upcoming International Airport at Panvel.

Site photo Site photo

Site Map Site Map

Facility USP Facility USP DEDICATED FORMULATION – LIQUID ORAL No chances of cross contamination and mix-ups  STATE OF THE ART FACILITY WITH Minimal MMI ( Man Machine Interface) . Closed Manufacturing Facility . Separate Manufacturing Vessels for different products and

batches. CIP (Cleaning in place ) system for cleaning of vessels. No use of potable water in the process areas. Dedicated Air Handling System for critical and non critical

areas. Automised Purified Water generation and distribution system

with generation capacity of 2000 Litres per hour. In house testing facility for chemical, instrumental and

microbiological analysis. 3 Tier Electrical safety system.

Accreditations and Regulatory Accreditations and Regulatory Approvals Approvals WHO-GMP CERTIFICATE c-GMP CERTIFICATE

Facility Highlights Facility Highlights Total Built-up Area : 24000 Sq Ft WHO-GMP Certified Facility. Strategically located for local as well as export work. Abundant availability of Technical staff and skilled /

semi skilled labour. Fairly large capacity Having broad range of products. Product development as per party requirement. Major Clientelle includes Mayer Organics, Lupin,

Zuventus Healthcare, Aristo Pharma, Genom Biotech, Appy Overseas ( Merchant Exporter), Indoco Remedies.

Facility Description Facility Description Total Built up area : 25000 sq ft. Modular wall panels sandwiched with puff insulation in between

both sides 0.8 mm G.I powdered sheet. Doors made up of Single leaf puff filled with puff insulation in

between both sides with both side flushed glass view panel.

5 mm Hilux jointless sheets with cutouts for diffusers, light

fittings and coated with 2 coats of white latex paint antifungal in

nature with primer.Ceiling made up of Single skin walkable false ceiling made out

of 24 G/0.6 mm G.I powder coated panel including cutouts for

diffusers, light fittings. Floor with Hard Granite tiles with flush skirting in non process

areas.

Epoxy flooring in process areas with flush coving.

Current output capacity Current output capacity Product Category Qty per Annum Quantity per Annum

Liquid Orals 3500 Kilolitres / year 35,000,000 Bottles of 100 ml per year

Future additional capacity Future additional capacity Product Category Qty per Annum Quantity per Annum

Liquid Orals 2000 Kilolitres / year 20,000,000 Bottles of 100 ml per year

Quality featuresQuality featuresMaterial Movement

Material Receipt at Gate &

Intimation to Stores

Vehicle containing Material forwarded to Receiving bay

docking area

Condition of vehicle checked & upon

satisfaction by Stores allowed to unload Material

Material unloaded in

Receiving bay

Material container dedusted and

weighed

Material transferred to Quarantine area

Material inwarded and GRN to QC

Material Sampled and transferred to Under test

area

Released Material transferred to Approved

material area

Approved material dispensed as per Prod requirement

Quality Control system

Receipt of GRN from Stores

Entry of material details in Inward register

Sampling of Material

Under test label on Sampled consignment Testing of Material

Approval / Rejection of Material

If Released Affix Approved Label

If Rejected Affix Rejected Label

Calibration of Instruments

Calibration of Volumetric Solutions

Disposed off in presence of QA / Stores pesonnel

Quality FeaturesQuality Features

Quality Features Quality Features

Procedure for the release of finished products

Bulk manufactured Intimation to QC QC Analysis

Upon Approval Intimation to Production for Filling & Packing

Filing packing done

Intimation to QA/QC for FG Sampling

QC Analysis Upon Approval Intimation to QA to release for sale

& distribution

Intimation to Stores by QA for Dispatch

Transfer to FG Stores

Filling & Packing AreaFilling & Packing Area

Stores AreaStores Area

Quality Control AreaQuality Control Area

Manufacturing AreaManufacturing Area

Lobby AreaLobby Area