IntroductionEstablished in the year 2008, “Bionext Pharma Pvt. Ltd.“ a

WHO-GMP certified company, is engaged in manufacturing, supplying and exporting an extensive range of high quality Pharmaceutical Products.

We at Bionext Pharma work at a state-of-the-art manufacturing facility with large and scalable capacity for production of formulations in liquid orals. Considering our focus on systems and processes with strict adherence of deadlines, we have proven and acquired a respectable position in manufacturing of Pharmaceutical formulation within a short span of five years. We at Bionext Pharma, thrive on the relationships built on the back of good, timely, reliable and quality services which we provide to our valuable clients.

It's our endeavor to work towards providing affordable and quality medicines across the globe, regardless of geographic and socio-economic barriers by striving hard to achieve excellence in research & development, manufacturing and ethical marketing of pharmaceutical formulations. We aspire and pledge to be one of the known and respected force in the pharmaceutical arena.

Mission VisionThe primary aim of Bionext Pharma is to produce world class

Pharmaceutical Preparations that not only meet the cGMP and WHO-GMP standards but also meet the economic considerations of our client who in turn is able to provide world class healthcare products that will improve lives and deliver outstanding value to the general end user.Mission

Along with research and development, innovation and automation will be the main mission for future business endeavors and will ensure our presence providing High Quality Products for Ultimate Customer Satisfaction.Vision

Our vision is to become most Preferred Manufacturing Company in the region by year 2020 and become A Globally Acclaimed Manufacturer leading the way with maintaining our rates in the pharmaceutical industry and supply value added products at reasonable prices by following our vision at every Department of our Organization.

We at Bionext Pharma in order to enhance our productivity, gain competitive edge in global market, strengthening financial viability has taken a purposeful view of implementing the ISO Standards.

ISO 9001 - Quality Management Standard:ISO 9001 is the internationally recognised standard for the quality

management of businesses.

Main Purposes:

ISO 9001 certification shows commitment to quality, customers, and a willingness to work towards improving efficiency.

It demonstrates the existence of an effective quality management system that satisfies the rigorous of an independent, external audit.

ISO 9001 certification enhances company image in the eyes of customers, employees and shareholders alike.

Accreditations

ISO 14001 - Environmental Management Standard (EMS)

ISO 14001 is the internationally recognised standard for the environmental management of businesses. It prescribes controls for those activities that have an effect on the environment. These include the use of natural resources, handling and treatment of waste and energy consumption.

Main Purposes:This demonstrates that your organisation is committed to

environmental issues and is prepared to work towards improving the environment.

It also gives a competitive edge to the company's marketing and enhances its image in the eyes of customers, employees and shareholders.

Accreditations

OHSAS 18001 - Occupational Health & Safety Management (OH & S)

OHSAS 18001 has been developed to be compatible with the ISO 9001 (Quality) and ISO 14001 (Environmental) management systems standards, in order to facilitate the integration of quality, environmental and occupational health and safety management systems by organizations, should they wish to do so. The (OHSAS) specification gives requirements for an occupational health and safety (OH&S) management system, to enable an organization to control its OH&S risks and improve its performance.Main Purposes:

Establishes an OH&S management system to eliminate or minimise risk to employees and other interested parties who may be exposed to OH&S risks associated with its activities. Implements, maintains and continually improves an OH&S management system. Assures itself of its conformance with its stated OH&S policy. Also demonstrates such conformance to others.

Accreditations

cGMPThe Company follows the current GMP ( Good manufacturing practices) as per revised Schedule M requirement under the provision of Indian Drugs & Cosmetics Act 1940 and rules there under.

Quality Policy

Quality Management

Quality Management system is in place with proper organization structure and responsibilities to achieve the goal of providing consistent quality in terms of efficacy, purity, quantity and delivery. Quality Management comprises of Quality Assurance Department, Quality Control Department and Regulatory affairs department.

Bionext Pharma , 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 service.

Quality

Quality Assurance

Responsibilities Includes :Monitoring of compliance to GMP requirements.Preparation and control of clearly defined production and control procedures.The approval and monitoring of vendors of starting materials, storage conditions for materials and products as designated.To approve or reject starting materials, packaging materials, intermediate bulk, finished products, sampling instructions, specifications, test methods and other quality control procedures.To check the maintenance of the department, premises, equipment & ensure that all necessary testing is carried out along with inspection, investigation, and sampling.The retention of records as per statutory guidelines also approve and monitor analysis carried out under contract.Monitoring and approval of Validation processes, Calibration processes, Stability programme and to monitor factors that may affect product quality.

Quality Assurance Department is headed by QA Manager and assisted by well trained qualified staff.

Monitoring Chemical Analysis.Monitoring Instrumental Analysis.Monitoring Microbiological Analysis.Monitoring Packaging Material Testing.Monitoring Retention of Control Samples.Monitoring Stability Testing Programme.Issue of Certificate of Analysis

Quality control department plays an important role since it demands the acquisition of reliable analytical data. Many important decisions are based on the analytical data of quality control department and it is important to have indication of the quality of these results

Our Quality Control Department is headed by QC Manager and assisted by well trained qualified staff.

Quality Control

Responsibilities Includes:

Regulatory Affairs:

Responsibilities Includes:

Regulatory affairs Department ensure that their companies comply with all of the regulations and laws concerning their business designed by regulatory authorities to protect public health

The Regulatory Affairs department is an important part of the organizational structure of pharmaceutical companies. Internally it liaises at the inter phase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.

Preparation of relevant statutory documents like Manufacturing licenses.Co-ordinate with FDA department for grant and renewal of regulatory licenses.Preparation of Export related documents.Finalization of artworks and text matter with respect to requirement of the party for design and country specific regulatory requirement.Follow-ups with the party and the regulatory authorities with respect to compliance of queries raised by the respective regulatory authorities.

Facility:We have developed a state-of-art-infrastructure, which is spread

across a fairly large stretch of property strategically located within the MIDC area. This infrastructure is divided into various units such as Manufacturing, R&D, Quality Control, Packaging, Warehousing, Regulatory & other ancillary Departments. The unit is equipped with latest technology, modern machines, tools and equipment in order to carry out the business in a streamlined manner. All these units are manned with our expert professionals who are well-experienced in the pharmaceutical industry.

Our quality experts test the source ingredients as well as final products for various parameters to make sure these are as per the prescribed quality. The production process is governed by the production plan and inventory status. After the receipt of plan, the programe for the month is prepared. The inventory of material is checked in the stores department and accordingly the planning for the batches is done.After the production process the entire range is stored in our warehousing unit where it is properly labelled by our experts to avoid any confusion during the delivery process.

Salient Features of the Facility :Automatic High Speed packing line with design speed of 200

bottles / min supported by all latest tools for visual inspection.Water System consisting of automised purification generation system of capacity 2000 lit / hr and distribution system.

Dedicated HVAC systems for Critical and Non-Critical areas with100000 classification. 3-Tier Electrical Safety System with Inverter and DG Backup. Air-Tight Clean Room light fixtures, electric panels, air curtains, UV-lights provision. Flush Windows and Doors with Air-Locks wherever necessary. Maintenance free Polished Tile walls, Puff Partitions and Ceiling. Seamless solvent – free epoxy flooring with appropriate covings and drain traps made of Stainless Steel.

Salient Features of the Facility: Dedicated Formulation-Liquid Oral plant that eradicates cross contamination and mix-ups.

Sufficient built up area that caters to all requisite cGMP norms for areas required for RM, PM, IN-PROCESS and FINISH GOODS.

State of the Art Facility with unidirectional and minimal MMI (Man Machine Interface).

In-House Testing Facility for Chemical, Instrumentation and Microbiological Analysis.

Close loop manufacturing with Vacuum Material Transfer System. Fairly Huge Capacity Manufacturing Vessels with 316-L moc and bottom mounted stirrers / homogenizers supported by requisite ancillary equipment’s and utilities that operate in tandem with each other and interlocked for any malfunction.

CIP (Cleaning In Place) system for effective cleaning of manufacturing vessels with DM Water only.

Product Category

Qty. Per Annum Qty. Per Annum

Liquid Orals

3500 kilolitres / year

3 50 00000 Bottles of 100 ml / year

Product Category

Qty Per Annum

Qty Per Annum

Liquid Orals

2000 kilolitres / year

2 00 00000Bottles of 100 ml / year

To support above production quantities, the plant is equipped with all requisite supporting tools, equipments and machineries as per cGMP guidelines

Current Output Capacity

Planned Additional Capacity

Plant Capacity

Why Us:

There is more than what meets the eye when we look at the Bionext Pharma logo. It has been scientifically designed to indicate all that we wish to represent and achieve.

Font : The Font used in our logo signifies Futuristic, Hi-Tech and the slant in the Font represents Progressive nature of the Company that embraces the latest in Technological Development and Quality Processes at all times.

Two leaves :

Two leaves indicates Strength & Longevity.

This Sign signifies Bionext Pharma is part of Larger, Healthier World which is represented with the Green Circle and Knowledge represented with Dark Blue Circle.

Dark Blue :Dark Blue Colour

signifies the Depth, Expertise,

Stability and Integrity amongst

us.

Green Colour: Green Colour signifies the

Growth, Renewal, Health and

Environmental Concern.

Our Logo:

Location & Address

International

Airport

Upcoming International Airport

JNPT

Port

Location & AddressSituated in a Pollution free zone of T.T.C Industrial area of Navi Mumbai in PAWANE MIDC AT A DISTANCE OF :

1) 2 KMs from Mumbai Pune National Highway2) 25 KMs from Mumbai International Airport3) 20 KMs from Jawaharlal Nehru Port Trust (JNPT)4) 10 KMs from Upcoming International Airport at Panvel

Bionext Pharma has created a business model that demonstrates a sustained and clear capacity for creativity and innovation in the development and implementation of its products & services. The business model demonstrates, Innovation in Products, Research & Development, Formulations Development, Development in Process & Packaging, Technological Developments, Sustained improvement in Product Quality, Timely Deliveries, Service & Customer Satisfaction, Competitive environment - Sales Price & Purchase, Sustained Growth with Excellence.

Staying Connected With Customer

At Bionext Pharma, Attributes of products are valued the most which includes:

Bionext Pharma understanding and believing the purpose of business: To create Customers To retain Customers To profit from Customers

Bionext Pharma manufactures and supplies medicine to many a top pharmaceuticals companies of India. In a short span of time, Bionext Pharma has become the Known Face of India's Healthcare and a Quality Pharma Manufacturer with Global Vision.

Good quality Timely Delivery Fair and Transparent dealings Willingness to improve Excellent packaging Freshness in stocks

Partnering

Domestic Business Bionext Pharma aims to be a key player in the Indian Market. Although a modest beginning we aim to be a known entity and plan at expanding to other dosage forms in the near future. At present the company manufacture products on Loan License and Principal to Principal basis of many a reputed pharmaceutical companies for their domestic as well as export requirements. We have been instrumental in developing and manufacturing formulations for various brands which are marketing them successfully in the highly competitive domestic market. We aim to increase our customer base by continually adopting latest cGMP norms, updated & committed personnel base and maintained & technologically updated facility. We sincerely believe in Quality at all times and develop our processes keeping it at the epicenter.

“Customer Satisfaction is Our Satisfaction".

International BusinessIn a Global perspective where in almost all the countries are increasing

their health care expenditure year on year, we feel we can be part of the scenario as we believe in “Quality Health Care at Affordable Prices”.We at Bionext Pharma assure our International Clients mainly of: Quality( Processes & Systems). A wide array of Quality Products. Competitive Pricing. Timely Delivery. Regulatory Support.We cherish building long term mutually benefiting associations by following Business Ethics mainly of: Fair and Transparent Dealings. Clear and Timely Communication. Abiding by mutually signed Agreements.

Bionext Pharma in its quest for Global Reach has targeted key regions of CIS, ASEAN, ASIAN and AFRICAN sub continents. At present the company is focused and in the process of fulfilling all the regulatory approvals for the same. We aim to be a key player in exports and help the global community in general with affordable quality medicines by adhering to strong quality systems, updated and well trained personnel, ultra modern facility, research and development and last but not the least a Clear Vision that incorporates QUALITY as its base.

At Bionext Pharma we assure:

At Bionext Pharma we seek:`

A broad range of high quality products.A fully compliant world class infrastructure.Strategic location of facility to ensure quick and efficient distribution of products.A well-qualified team of members to handle all your requirements timely and efficiently.Ethical and Transparent Business dealings.

Strategic partnerships to enhance mutual growth.Alliances for contract manufacturing on loan license basis.Alliances for manufacturing on principal to principal basis.Alliances for product development.Alliances for domestic / international pharma trade.Alliances for technology transfer.Specialist Alliances for Research & Development.

We Seek / We Offer.