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Objectives

To get practical knowledge of Operation Management. To Visit Plant and get information of various operation tool. To get knowledge about product and process layout. To know factor affecting to location. To know quality policy of company. To know inventory management of company. To know how to design job. To know overall operation strategy.

INTRODUCRION
Claris Life sciences is an international pharmaceutical company, in the business of manufacturing and marketing sterile potential preparations, life saving medicines and hospital products, focusing on delivery systems, for treatment of critical illnesses and diseases. With emphasis on Research, Technology and Quality, Claris offers a range of unique products and delivery systems in bottles, vials, ampoules, pre-filled syringes, non-PVC/PVC bags and oral dosage forms. The company's strength lies in its know-how and expertise in manufacturing and marketing inject able products. Driven by a team of scientists, pharmaceutical experts and management professionals, Claris is powered by a combination of Vision, R&D capabilities, Technological know how, International standards and Manufacturing expertise. The company's range of products and delivery systems extends across Enteral and Parenteral Nutrition, Anaesthesia, Blood Products and Plasma Volume Expanders, Anti-infectives, Dialysis and Transplant, Cardiac Care, Infusion Therapy as well as Medical Disposables and Equipment. Claris enjoys Market Leadership in India. the company operates in more than 76
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Globally,

countries, through its subsidiaries, offices and marketing/distribution network, and a diverse customer profile covering institutions, major corporate hospitals and international aid agencies.

Vision
To be one of the worlds leading and most admired pharmaceutical companies in the global Generics industry. To continually create value and bring pride to our stakeholders, partners, customers and the community at large. To preserve human lives. earths most precious resource

Mission
A world-class organization, built on, Outstanding performance led by Entrepreneurial culture. Product quality through Emotional Pharmacopoeia. Management capability, Efficient processes and Technology. Youth, hard work and discipline. Achieved in a manner of fairness, honesty and corporate responsibility.

Certifications/Recognitions
Accepted by international regulatory authorities including USFDA, MHRA(UK), TGA (Australia), NAM (National Agency for Medicine) Finland, GCC (Gulf Cooperation Council), ANVISA (Agencia Nacional de Vigilancia Sanitaria), INVIMA (Instituto Nacional de Vigilancia de Medicamentos Y Alimentos) IDMA Quality Excellence Award for 2nd Consecutive year Certified for ISO 9001:2000

Businesses
Clinical Nutrition Anesthesia Plasma Volume Expanders Blood Products Advanced Anti-infectives Renal & Transplant
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Oncology Infusion therapy Disposables & Equipment Pharmaceutical Generics

Market Presence
Presence in 76 countries across Latin America, Europe, Gulf, Africa, CIS, Central Asia and Asia- Pacific Subsidiary companies, laboratories, office infrastructure Grass root marketing & brand building Supplier to aid agencies

Competitive Edge
1st to introduce several products in India No single Indian company having similar product focus Few International players Extensive S&D network

Capabilities
Regulatory Trained and committed manpower for regulated/non-regulated markets, IPR and Clinical trial studies. Sound and complete understanding of International Regulatory Requirements. Successfully attained key international regulatory approvals including USFDA, MHRA(UK), TGA (Australia), NAM (National Agency for Medicine) Finland, GCC (Gulf Co-operation Council), ANVISA (Agencia Nacional de Vigilancia Sanitaria), INVIMA (Instituto Nacional de Vigilancia de Medicamentos Y Alimentos) Submitted over 1532 dosiers.

Marketing Authorisation applications filed in several regulated markets.

R&D New Products Formulation Development Outsourcing components Alliances New concepts development ( eg. PNA) New Drug Delivery Systems Two Platforms Lipid based D D S Liposomal D D S Development of API with DMF source Contract Research Team of experienced scientists. Full fledged center with advanced equipment Drug Delivery Systems Active Pharmaceutical Ingredients (APIs)

Major Platforms Fat Emulsion Technology Liposomes Biotechnology

Manufacturing
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and

World class facilities designed to produce aqueous oil based products. Contract Manufacturing Capabilities Bags PVC/Non-PVC Multi-chamber bags Double bag systems Glass containers Bottles Vials Ampoules Aseptic manufacturing Liquid form Oral Form Lyophilization

Prefilled syringes Glass Plastic Liposomal technology Soft gelatin capsules Blow-Fill-Seal Blow-Fill-Seal

PRODUCTS
Key Products

Parenteral Nutrition
Parenteral Amino Acid Solution Parenteral Fat Emulsion Parenteral Nutrient Admixture Total Nutrient Admixture Parental Trace Elements Combination Nutrition Pack Combination Nutrition Pack

Enteral Nutrition
Supplementary enteral nutrition. L-Glutamine Powder Nutritionally Balanced Enteral Diet Truly Versatile Yet Elemental

Anesthesia
Propofol MCT LCT Intravenous Injection Propofol Intravenous Anesthesia Sufentanil Citrate Injection USP

Plasma Volume Expanders


Tetrastarch Pentastarch/Hetastarch

Blood Products
Normal Immunoglobin Enoxaparin Sodium Inj. Top

Anti-Infectives
Linezolid IV

Ciprofloxacin IV Ofloxacin IV Levofloxacin IV Gatifloxacin IV Metronidazole IV Cefpirome IV Ceftazidime IV Ceftriaxone IV Cefotaxime IV Cefotaxime Sodium + Sulbactam Ceftriaxone Sodium + Sulbactam Cefoperazone + Sulbactam Piperacillin + Tazobactam Inj. Cefepime Injection Linezolid IV Top

Renal & Transplant


Iron Sucrose Injection USP Cyclosporine Sirolimus Mycophenolate Mofetil Triple Chamber CAPD System Recombinant Human Erythropoietin Alpha Ketoanalogue Tablet

Nutrition

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Nutrition solutions from Claris include Enteral and Parenteral Nutrition products and delivery systems. Claris has a product range encompassing advanced delivery systems in double and triple chamber bag like PNA, Celemix-G and TNA/TNA-Peri, amino acid solutions, fat emulsions, and trace elements. TNA -Peri offers the unique advantage of an advanced triple chamber bag system, with the convenience of peripheral administration.

Glutammune (l-glutamine), an innovative enteral nutrition introduction from Claris, is a product that is getting global recognition for its versatile benefits in patients of critical illness like Cancer, Trauma, Burns, GI Diseases and Neurology. Nourish is a nutritionally balanced diet, available in seven different variants to meet the special nutrition needs of patients with different disease conditions.
List of Products
Enteral Nutrition Supplementary Enteral Nutrition L-Glutamine Powder Nutritionally Balanced Enteral Diet Glutamine I. V. Parenteral Nutrition Parenteral Amino Acid Solution Parenteral Fat Emulsion Parenteral Nutrient Admixture Total Nutrient Admixture

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Parental Trace Elements Combination Nutrition Pack Combination Nutrition Pack

Anesthesia The company's expertise in lipid-based technology has made it one of the few companies in the world to manufacture propofol. Provive/Profol is an internationally accepted brand and the no. 1 brand of propofol in India as well as diverse countries across Latin America, Asia, Africa and the CIS. Marketing Authorization Applications for propofol have been filed in several EU countries, Australia and New Zealand. Complementing Provive/Profol is the powerful narcotic analgesic Sufentil (sufentanil). Claris is the only company to offer Sufentil in India. The anesthesia basket has other products including Sedoz (midazolam), Ketajex (ketamine), Thiojex (thiopentone), Sensinil (lidocaine) and Bupican (bupivacaine).

List of Products
Bupivacaine Injection Ketamine Injection Propofol Intravenous Anesthesia Syringe Infusion pump for anesthesia Midazolam Injection BP

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Lidocaine Injection IP Sufentanil Citrate Injection USP Thiopentone Sodium for Injection IP

Performance in India
Having established its presence in India in 1999, Claris continues to grow from strength to strength with every passing year. Claris enjoys market leadership across several products and categories in India including propofol, parenteral nutrition and IV fluids. The company continuously endeavours to support upgrade of medical care in the country with the introduction of breakthrough new products and technologies. It has several firsts to its credit including The revolutionary new anaesthetic propofol under brand name Profol Oral glutamine under brand name Glutammune Triple chamber CAPD system Trisafe The highly potent narcotic analgesic Sufentil

Triple chamber nutrition system with parenteral route administration TNA Peri Claris customer base in India includes institutions, large corporate hospitals and nursing homes, translating into a user base of 25000+ individual doctors.

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In line with its commitment to the cause of critical care in the country, Claris remains at the forefront of efforts towards medical education including participation in several national and international congresses, sponsorship of training programs for young doctors, publication of scientific journals and other such initiatives.

Performance in Abroad
The company has a presence in more than 76 countries across North America, Central & South America, Europe, China, CIS, Asia Pacific, Middle East and Africa through its own sales force and local teams in various countries. Additionally, Claris enjoys a unique position in the regulated markets because of its know-how and expertise in manufacturing injectable products. The company has identified regulated markets comprising North America, the European Union, Central and East Europe, the Far East, Australasia and the Middle East, as one of its major drivers for growth in the coming years. Claris is in the process of establishing an extensive marketing and distribution network in all the regulated markets and has also filed its dossiers for product registration in key regulated markets. To spearhead its sales and distribution activities in Europe and the USA, the company has established its own subsidiaries Claris Lifesciences Limited (U.K.) and Claris Lifesciences Inc., USA. To cater to the high potential Chinese market, the company also established a representative office in China.

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A significant share of the company's revenues come from international operations, and several major brands like Profol (propofol) , Hestar (hydroxyethyl starch) and anti-infectives like Ciprox/Ciprocina (ciprofloxacin), are widely recognized and accepted globally. Our teams in international markets include sales, marketing and support people, ably complemented by a strong network of distribution partners. This level of infrastructure in international markets helps us meet the demands of our international customers including aid agencies, large corporate hospitals and institutions.

Manufacturing Facilities

Claris manufacturing facilities are designed to produce aqueous and oil-based products in glass/PE containers and bags. The facilities practice cGMP and are ISO 9001:2000 certified. Apart from manufacturing for Claris, these facilities also cater to the needs of companies in India and abroad for international markets on contract manufacturing. International regulatory authorities including USFDA, MHRA (UK), TGA (Australia), NAM(Finland), GCC (Gulf Co-operation Council including Saudi Arabia, U.A.E. and other Middle East countries), ANVISA (Brazil) and INVIMA (Colombia) have approved the sterile parenteral preparation manufacturing facilities. Technology/Manufacturing Capabilities

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The company has capabilities in bringing laboratory batches to full production scale successfully, through its process engineering competence. This technological excellence also goes beyond process and it has executed several projects with its technology platforms including: Manufacturing Technologies Product Platforms 1. Bags PVC/Non-PVC Multi-chamber bags Double bag systems Parenteral Fat Emulsion technology

2. Glass containers Bottles Vials Ampoules Micro-emulsion technology

3. Aseptic manufacturing Liquid form Oral form 4. Cytotoxic manufacturing Glass Plastic

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Emotional Pharmacopoeia
A total commitment to quality, coupled with international exposure to technology, aids us in our efforts to help save human lives worldwide. At the core of our Quality Philosophy is the commitment to achieve a level of perfection that matches the highest international pharmacopoeial standards. Our final test for Quality is a very simple question that we ask ourselves without fail. Would we use it to treat our dearest ones? If the answer is an unhesitant Yes, The product has passed our final quality test. We call this Emotional Pharmacopoeia.

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The company's focus on quality begins with the use of world class Clean Rooms to house the central laboratory facilities. The state-of-the-art laboratory set up is equipped with facilities for chemical and instrumental analysis. Capable of undertaking the most comprehensive tests, the laboratory has equipment sourced from internationally renowned suppliers. This facility is validated as per international regulatory authorities' expectations. A full-fledged dedicated validation team worked continuously at the time of inception, to achieve the levels of validation required, and ensures the same on a regular basis. To build quality through every step of production there is a separate team for in-process quality assurance (QA) and finished products' testing (QC) at the end. Separate managers head both these functions. Claris' sterile parenteral preparations manufacturing facility has won the prestigious IDMA Quality Excellence Award two years in a row, in recognition of its Quality practices.

Quality Policy
We shall strive to fulfill our objective of saving lives worldwide by dedicating ourselves to manufacturing and marketing products of International Quality by achieving excellence in all aspects of work.

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We shall achieve this by building Quality into our products and services through Research, Technology, Systems, Policies and Practices, People and benchmarking against internationally accepted norms of excellence. It will be our endeavour to bring delight to our internal and external customers through excellence and continuous improvement.

Conclusion
It was unforgettable experience to visit company like Claris. We came to know many facts of operation management. We got practical knowledge. By seeing the plant of Claris, we found that plant was very clean and workers were using all kind of safeguards. Plant layout and its arrangement and quality policy indicated that they are so much quality conscious. Claris has strong R
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& D and manufacturing facilities. But as far as our knowledge is concern Claris has failed to cover domestic market compare to its competitor Zydus Cadila. Now a days dog eats dog competition is going on and Claris next door competitor already jumped in retail medical store like Dial4health of Zydus Cadila. We want to suggest that Claris should also jump into this foray or it should start hospital to promote its brand.

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