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Project Report

Nov 25, 2014






Preface Acknowledgment Objective Of Study Company Profile Company Business, Mission & Objectives Swot Analysis Companys Product About Companys Project Analysis Findings Reccomendations & Lmitations Conclusion Bibliography


The parent company, Windlas Steel Crafts established by late Mr. Ved Prakash Windlass in 1943 to manufacture Gurkha Khukris for the British Army in India, is today a worldwide leader in the swords business and an approved vendor to the United State Govt. and other European countries. Guided by golden words: Technology, Finance, Strategy and Planning.

Its Associates: WINDLASS STEEL CRAFTS(Edged Weapons Exports)

WINDLASS REALTORS & DEVELOPERS(Projects Builders & Estate Developers)


Overseas: ATLANTA CUTLERY CORP.Mal Order Business (USA) Mal Order Business (USA)

MUSEUM REPLICAS LTD.Family entertainment theme park (USA) Military swords (UK)



WINDLAS BIOTECH LTD.Windlas Biotech Ltd, is the flagship company of the reputed Windlas Group. It is one of the growing WHO-GMP &ISO 9001:2000 certified Tablet, Capsule, Oral Liquid & small volume Parental Manufacturing industry engaged in the contract manufacturing & loan licensing business. It was set in 2000, under the able guidance of Mr.Ashok Kumar Windlas (M.D), at mohabewala, Dehradun (U. K). It is a well known outsourcing partner for leading pharmaceutical companies in various countries around the world like Emcure, Lupin, Mankind, Wochardts etc. It has recently set up a most advance F&D facilities.

About Windlas Group Our Mission Manufacturing Quality Formulation Development Services Customer Satisfaction People

Business Development Safety, Health & Environment Future MISSION:Its mission is to be the choices outsourcing partner for leading pharmaceutical companies in various countries around the world by continually offering them new validated formulations on the basis of process based Research & development. They are committed to take an innovative, responsible and sustainable approach towards meeting the healthcare challenges of mankind. They contribute to achieve real and sustainable results by developing medicines and making them available through partnerships at affordable prices to promote coverage of healthcare.

VISION:Their vision is to advance as a manufacturing support structure for global pharmaceutical companies catering to regulated markets under collaborative arrangement. Thus providing a broad spectrum of outsourcing solutions.

MANUFACTURING:WBL being one of the leading business ventures of the Windlas Group. Constantly strives to do better, and excel in its field of pharmaceutical formulations. Their strength lies in the manufacturing of products in dosage form of tablets, capsules, liquid orals and small volume Parenteral. The following are their manufacturing capacities for respective dosage forms. Tablets 900 million/yr

Capsules Liquid Orals Parenteral

180 million/yr 30 million/yr 70 million/yr

To complement processing capabilities, the company provide a range of packaging configurations, with extensive capabilities in different pack sizes and formats like: 1. For tablets and capsules Strip packing Blister packing Alu-Alu Blister packing Orals 2. For liquid orals Glass and Pet Bottles 3. For solid Orals Glass and Pet Bottles Sachets 4. For Parenteral Ampoule Blister packing Ampoule trays


Bulk Drug Substance

Preformulation studies

Prototype Formulations development

Bioavailability& Bioequivalence studies Stability studies

Scale up & Validation Tech Transfer Commercial manufacturin g

Product Registration support

Quality is inherent at WBL. The quality of a product involves many parameters that cannot be evaluated by mere visual control. Thus at WBL they have established an extensive quality system with the purpose of verifying and satisfying the product quality and manufacturing process. The quality assurance and quality control departments support WBLs development activities and are responsible for visual control of sample and for verifying a certificate of analysis of each consignment. The technical files of all individual products are also continuously evaluated, and are further submitted for independent re-analysis according to our internal control analysis program to ensure they meet the analytical specifications. WBLS facilities are validated for Good Manufacturing Practice (GMP) production and are regularly agencies. They work to comply with the appropriate FDA (Food and Drug Authorities) requirements of manufacturing facility qualification audits and for the manufacture of pharmaceutical formulations.


They keep their research and development in line with their business strategy to drive their pharmaceutical business forward. A well equipped laboratory and pilot plant with state-ofart equipment and their qualified staff, ensure quality minded production. Full quality and regulatory support is available for the products.

Pre-formulation services Raw material sourcing Physical properties Powder characterization Active solubilitys and partition coefficients. Active compatibilities with other materials and excipients.

Active stability and factors affecting stability (O2, heat, light sensitivity, effect of Ph)

Formulation and packaging compatibility. Formulation and package prototype

Formulation Services: Formulation development for early safety studies Prototype formulations for bioavailability and bioequivalence studies Process development for pilot and commercial scale manufacturing.

Commercial formulation development & analytical development services:

Method development & validation Cleaning residuals development & validation Dissolution and drug release proofing Forced degradation studies Specifications development Stability monitoring to ICH guidelines

SERVICES:WBL focus exclusively on outsourcing with clear focus on meeting client needs through flexibility, creativity and service excellence. By serving the manufacturing needs of many renowned international pharmaceutical companies. Professional project managers, dedicate quality control and assurance units, together with environmental, health and safety systems, fully support their manufacturing services.

Their range of services includes: 1. Formulation development. 2. Process validation. 3. Stability studies design and monitoring using ICH guidelines. 4. Manufacturing, packaging and release testing of registration batches. 5. Distribution and logistics. 6. Adequate documentation for drug application. 7. Experienced PAI (pre approval inspection) team. 8. Complete data for notification dossier. Their success as outsourcing specialists is the result of focusing on their clients top priorities, including quality products, flexible manufacturing, On time delivery and unparalleled responsiveness. By meeting these priorities they have established longterm relationships with clients.

CUSTOMER SATISFACTION:For WBL customer satisfaction is the yardstick to measure quality of its products and services. Customer satisfaction is their prime priority which they ensure by providing the best solution that fulfill their customers needs and expectations.

120 100 80 60 40 20 0 North West East

Overall Evaluation

Product Product Would Value Quality recommend to others

Customers regard us as a valuable, reliable and trusted business partner, geared to meet their expectation in terms of confidently, timing, quality, costs and providing added value, way beyond the simple fulfillment of the contract. WBL have a Microsoft Navision ERP management system to conform to the latest standards of online batch manufacturing and process control which enables them to achieve maximum productivity and timely deliveries to their customers.

PEOPLE:Their most important assets are their qualified & dedicated personnel. Their extensive expertise in process oriented project management provides responsiveness that makes a difference. All sales and business development personnel are fully versed in the outsourcing requirements, of a variety of complex projects. To reach their aim of gaining higher benefits they employ well trained, motivated and focused employees. Working on an independent and self responsible basis. They at WBL thrive to have the most productive team of people in terms of flexibility, efficiency, innovation and reliability to exemplify the spirit of co- operation and energy.

BUSINESS DEVELOPMENT:The ability to anticipate change and the foresight to help shape charges continuously as they emerge, enhance success. Their strategy as a dedicated contract manufacturer is based on providing a complete but flexible development and manufacturing package created through close interactive partnerships with their customers. The company enters into manufacturing agreements with medium to large sized sales and marketing organizations that are specialists in branding but want to outsource manufacturing. This strategy has proven to be successful and enabled them to retain flexibility to meet the demands of the customers without affecting the security of suppliers, quality and continuity.

They combine unparalleled experience. A proven track record, technical expertise, financial security, high quality standards and superior management to ensure that their services match their customers expectations in every detail. To maintain their financial