Existing Facility (100,000 sq. ft.)

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2 To be the first choice for critical purification and separation applications through innovation and value maximization Existing Facility (100,000 sq. ft.) New GMP Facility (100,000 sq. ft.) Advanced Microdevices ( mdi) is a leader in innovative membrane technologies. Starting from a single person R&D operation in 1976, mdi has developed into a dedicated team of 300 plus with more than products. The company s core competence is its ability to develop new membrane technologies and innovate existing ones to deliver advantages to the customer for high end purification and separation applications in a wide range of industries such as pharmaceuticals, biopharmaceuticals, biotechnology, food and beverage, hospitals and immunodiagnostics. As membranes end up being incorporated into user friendly devices, plastic design and moulding and sealing technologies become an integral part of the chain to deliver value to the customer. Realizing this, mdi has grown into a vertically integrated company that helps deliver prototypes rapidly for quicker conversion to products for the market. mdi products are used for sterilization of injectable drugs, for sterility testing, for sample preparation of drugs that are tested with highly sophisticated instrumentation, for development of new drugs, for making reliable immunoassays for testing of diseases at patient bedside. These are all very critical applications and the industries are highly regulated. mdi s modern GMP facilities with large ISO 7 Clean Areas more than meets the required standards. The products are manufactured in ISO 9001:2008 certified facility with the help of highly trained manpower. Separate QC and QA departments assure the maintenance of standards. mdi products meet or exceed industry standards. Many mdi products are recognized as the best available in the world. mdi has a strong pipeline of new products constantly being developed in its well equipped R&D labs.

3 CORPORATE HEADQUARTERS Advanced Microdevices Pvt. Ltd , Industrial Area Ambala Cantt , India Tel: , Fax: info@mdimembrane.com Year of Establishment: 1976 Core Activity: Membranes and Membrane Filter Devices Number of Employees: 300 CERTIFICATIONS US FDA DMF Registered, # ISO 9001:2008 Certified ISO 13485:2003 Certified FACILITIES Unit-I: Membrane Manufacturing and Device Fabrication with QC and R&D Labs , Industrial Area, Ambala Cantt India Built up Area: 10,000 sq. meter Manufacturing Area: ISO 7 Clean Areas Unit-II: Plastic Moulding Division Jawahargarh Road, Village Tepla, PO Saha Ambala , India Built up Area: 2000 sq. meter Unit-III: Membrane Manufacturing and Device Fabrication with Validation Lab, QC and R&D Labs Jawahargarh Road, Village Tepla, PO Saha Ambala , India Built up Area: 10,000 sq. meters Manufacturing Area: ISO 7 & ISO 8 Clean Areas

4 mdi offers its range of products through four divisions. Process Filtration Division serves Pharmaceutical Parenterals, Biopharmaceutical, Bulk Drugs, Water Treatment, Food and Beverage industries and offers products such as heat sterilizable as well as gamma sterilizable capsule filters and cartridge filters for sterile filtration of liquids and gases. These filters are deeply validated and are used for filtration from few liters to thousand of liters, Asertain Validation Services for filter validation with drug products is an important part of this division. These services are offered to meet the requirements of USFDA as per PDA report number 26 guidelines and complete documentation is provided for the physico-chemical compatibility integrity test values, bacterial retention capability and the extractable analysis of the filters. Laboratory Filtration Division sells smaller filters for various laboratories in different industrial sectors. The filters find use in analytical sample preparation and water and product microbiology in pharma and food and beverage industries. They are also used for sterility testing of parenteral products. The division offers complete solutions to the customers including necessary hardware and equipments. Life Science Research Division offers pre-sterilized low protein binding filters for filtration of biologicals used in life sciences research and also various transfer membranes for protein and nucleic acid analysis. In addition to the above, this division produces as very wide range of Nucleic Acid Purification Kits for DNA and RNA isolation/purification from diverse samples for use in life sciences research as well as for use in molecular diagnostics. Diagnostics Materials Division produces unique materials which allow production of high quality immunology based rapid tests as well as tests for point of care systems. Among the outstanding products is the widest range of nitrocellulose membranes for lateral flow tests as well as blood separation membranes for sample preparation and sample collection for medical diagnostics. This division also sells development and production machines for producing rapid tests.

5 Manufacturing Areas mdi products are used in critical applications in pharmaceutical, biopharmaceutical and other industries. In order to meet the expected standards with respect to bioburden, endotoxin levels, particle/fiber release and contribution to impurity profile from filters, these products are produced and packaged in GMP facilities with ISO class 7 clean room areas certified by external agencies and monitored internally for viable and nonviable particles and air flows. Employee hygiene, change rooms, gowning and de-gowning procedure and continuous monitoring of the areas is an essential part of these facilities. These facilities have been designed for unidirectional work flow with class 8 corridors around class 7 production areas, with appropriate change rooms for personnel and pass boxes for material movement. The material of construction allow easy cleaning and prevent build up of dirt and dust. Well defined and organized clean storage space with separate ISO Class 8 storage areas for quarantine and incoming testing is provided and separate finished goods store is situated next to the dispatch section. Transfer of finish goods from manufacturing areas to storage is through pass boxes. HVAC System The requirements of safe and efficient workplace with controlled environment for high product quality are ensured by well designed and validated HVAC systems. The system also ensures appropriate pressures in different classified zones. For reliability and efficiency of operation, two stage HEPA filters are used at critical location as well as at the end point locations in ISO Class 7 areas. Building Management System The entire building is controlled by a central computerized Building Management System which allows the cleanliness, pressure, RH and temperature parameters in all classified zones to be met with efficiency. Utilities RO/EDI Water System Large capacity RO/EDI water system to meet USP requirements for purified water. A recirculating loop distribution system ensures that critical parameters such as microbial content. ph and conductivity are well controlled. The system has been validated and continuous monitoring and trend analysis assure that quality standards are met. Engineering Support A well developed machine tool room provides the required engineering support for development of new machines for new processes as well as automation of existing ones. The engineering group also designs and develops the dies and moulds for new plastic components.

6 Testing labs at mdi Production at mdi is supported by highly developed test laboratories. These labs are equipped with latest instrumentation and run by highly skilled personnel. Microbial Test Lab for Bacterial Challenge Testing to test Retention Efficiency of Filters, Sterility Testing, Microbial Load Testing, Bacterial Endotoxin Testing, Environmental and Utilities Monitoring and Recovery of Organisms from various filter products. Reliability Lab to establish limits for conditions of use of filters and the operation limit of filters. Filter Test Lab to check physical parameters of various filters. Analytical Lab to measure, detect and identify extractables and leachables from filters and particulate retention efficiency of filters etc. Protein and DNA Lab for quality control of Nucleic Acid Purification Kits, Transfer Membranes and filters with regard to critical functional parameters such as yield, purity, protein binding capacity etc. Diagnostic Materials Lab for quality control of membranes and other materials for diagnostics. Microbiology Lab The microbiology lab include separate areas for bacterial retention testing, sterility testing, microbial limit testing, bacterial endotoxin testing, and culture lab with independent HVAC systems for each, to ensure highest level of controls. These labs are fitted with latest biosafety cabinets and vertical laminar flow benches and dynamic pass boxes and have state of the art, in-house developed test jigs for filter pre-treatment and bacterial challenge testing with online controls. Validation Lab Since customers often require filter validations with specific drug products, mdi has set up a dedicated laboratory to provide Asertain Filter Validation Services. The laboratory has the facilities to handle customer samples, including oncology drugs and simulate customer processes related to filter use and report the results as per the requirements of PDA Technical Report 26.

7 Quality Policy: mdi strives to provide to its customers products and services of highest standards possible, consistently superior, and more satisfying than what is available anywhere else Quality is built into mdi products and services by not only adhering to well designed quality systems to consistently produce high quality, internationally acceptable products but also by striving to incorporate superior performance parameters into all our products and services and provide our customers with a unique performance advantage in their application. All activities at mdi are governed by stringent Quality Management System (QMS) certified for ISO-9001:2008. mdi has a well defined change control system and any changes in any of the manufacturing processes are incorporated across the board internally and if there is an impact on product identification or performance parameters, these are notified to customers through Change Notice. The documentation system is in accordance to the ISO-9001 Quality System requirements. The documents are created, reviewed, approved and distributed according to the written system. Specified Documentation Rooms have been provided for keeping the Quality System Documentation as well as laboratory specific records. There are independent departments for Quality Assurance and Quality Control. The Quality Assurance department ensures regular need based training and skill/knowledge upgradation of mdi employees. QA also leads the process and product validation activities at mdi. Each product is deeply validated to ensure conformance to pre-determined specifications at the design level and comes with a complete validation documentation package. A continuous monitoring system of the facilities and the manufacturing processes through statistical trend analysis and internal quality audits helps maintain the required standards.

8 The focus to develop high-quality filtration and separation products exceeding performance specifications normally accepted in the industry drives R&D to provide innovative, cutting edge solutions. Multidisciplinary integrated R&D with over 30 scientists including PhD s and Postgraduates in multiple disciplines such as chemistry, biotechnology, electronics and mechanical engineering provide unique abilities to develop new and innovative products that offer advantages to our customers. Any R&D project for new product development or development of new processes and test methodologies involves a team of personnel from design and development, application development, manufacturing and quality assurance. The application development team works closely with R&D to provide market inputs with respect to key application requirements, customer concerns and competitor information to help define performance levels beyond customer expectation. Personnel from manufacturing and quality assurance provide the necessary inputs for developing consistent production processes and test methodologies.