Manufacturers of. Pharmaceutical Formulations Active Pharmaceutical Ingredients Drug Intermediates ULTRATECH INDIA LIMITED

Size: px
Start display at page:

Download "Manufacturers of. Pharmaceutical Formulations Active Pharmaceutical Ingredients Drug Intermediates ULTRATECH INDIA LIMITED"

Transcription

1 Manufacturers of Pharmaceutical Formulations Active Pharmaceutical Ingredients Drug Intermediates ULTRATECH INDIA LIMITED

2 Profile Ultratech India Limited is a WHO-GMP and ISO certified Pharmaceutical company that manufactures and markets a wide range of Pharmaceutical Formulations in various dosage forms (Tablets, Capsules, Syrups, Gels, Injections, Nasal Sprays, Dry Powder Inhalers and Metered Dose Inhalers), advanced Drug Intermediates and Active Pharmaceutical Ingredients. Ultratech was formed in 1992 & in its two decade journey established itself as a Multi-national company manufacturing world-class Pharmaceutical products with a diverse product portfolio that includes Pharmaceutical Ethical Drugs, OTC, Nutraceutical and Cosmetic Products for a broad spectrum of applications. The company has its offices in India, Ukraine, Bulgaria and Nigeria with a global clientele in more than 25 Countries. Our products are manufactured in line with FDA guidelines and cgmp requirements. Most of our products are supported with DMFs, Dossiers, FSCs, COPPs and registration files for obtaining Product registrations as per Country specific requirements with the help of our highly experienced and qualified regulatory team. Ultratech is an excellent combination of world class manufacturing, R&D, Quality control, Quality Assurance, Marketing and in-depth Management expertise. Chairman's Mission Statement I strongly believe in caring for human health by building a GenNext transnational Ultramodern Pharmaceutical Company! Our Vision -Rishi Bhatia Chairman & Managing Director To become a leading global healthcare organization driven by people, research and technology by developing innovative products to prevent & cure diseases and enhance quality of life. Our Focus Dedication to GenNext Healthcare Manufacturing and R&D excellence Expansion of product portfolio Stringent QC & QA control (TQM) Our Customers go back with optimum satisfaction and a big smile!

3 Our Business Ultratech is a transnational pharmaceutical manufacturing company and has a diverse product portfolio to offer; ranging from a wide spectrum of Pharmaceutical formulations, APIs to advanced Drug Intermediates. Pharmaceutical Formulations in various dosage forms Our products covers most of the therapeutic segments like Analgesics, Antacids, Antispasmodic, Antiasthmatics, Antibiotics, Antid i a b e t i c s, A n t i - d i a r r h o e a l s, Antihypertensives, Anti-infectives, Anti-inflammatory/ NSAID's, A n t i u l c e r a n t s, A n t i v i r a l s, Cardiovascular, Corticosteroids, Cough & Cold Preparations, Dermatological Products, Herbal Products, Lipid Lowering Agents, Nasal Decongestants, Nutritional & Health Supplements, Psychotropics & Antidepressants, Urological & Erectile Dysfunction drugs. Tablets Capsules Syrups Gels Injections Nasal Sprays Dry powder Inhalers Metered Dose Inhalers Active Pharmaceutical Ingredients & Drug Intermediates Antiasthmatics Anti Diabetics Antifungals Antihistamines Anti-inflammatory Anti-osteoporosis Cardiovasculars Gastrointestinals Erectile dysfunction CRAMS (Custom Research And Manufacturing Services) We undertake Custom Synthesis for new molecules, Process Development work of Bulk Actives as well as for Pharmaceutical dosages, Private Labelling & Contract manufacturing. Ultratech... One stop shop for healthcare needs

4 Pharmaceutical Formulations Ultratech provides a wide range of pharmaceutical formulations in conventional as well as advanced dosage forms. Our Product range covers most of the therapeutic categories. We are currently expanding our presence in the branded generics international markets by producing & exporting a wide range of products. Attractive production costs, high quality production standards, availability of product Dossiers in CTD formats and complete registration documentation makes us a suitable partner in the global pharma business. Ultratech provides new product development through continuous innovation from its R&D plant & the processes are then scaled up for large scale production from its licensed manufacturing WHO- GMP plants in India which are already certified by various regulatory authorities in the world and have adequate capacities. Ultratech participates in building long term partnerships with its customers worldwide. We understand our customers needs, we deliver beyond expectations! Active Pharmaceutical Ingredients & Intermediates We manufacture Active Pharmaceutical Ingredients & advanced Drug Intermediates catering to various therapeutic categories. Our sophisticated infrastructure has been designed to provide customers with flexibility in product mix, increasing production volumes and quick reconfiguration to align our processes with the market needs. Our team has gained an immense expertise in handling complex chemical reactions such as Acylation, amination, diazotization, alkylation, hydrogenation, halogenations, chiral separations, and various innovative chain reaction processes for new chemical entities for the developed and developing markets. Backward integration and innovation in complex chemical synthesis - Our obsession!! Custom Research And Manufacturing Services (CRAMS) Ultratech offers the complete package; right from development of drug intermediate stages moving up to developing API s and finally the formulation dosage forms, commercial manufacturing and packaging. Innovative labeling, Packaging, and designing can be made as per customer's requirement based on their local market needs. We also provide Neutral labels, designs and calligraphy in different languages, product coding and customized packaging. Our R&D team constantly provides cost reduction by adopting new methods, process simplification, standardization and technology upgradation. We offer services for : ŸProcess development of Pharma dosage forms, API s & Drug Intermediates ŸFormulation development in different dosage forms ŸSynthesis route development and optimization ŸImpurities synthesis and identification ŸDeveloping environmentally friendly processes ŸTechnology transfer ŸB.A., B.E. & Stability studies ŸDossier and DMF development ŸPrivate labeling & Commercial manufacturing in large volumes Ultratech offers a single window convenience to its worldwide clients for Formulations, APIs & Contract manufacturing

5 Our Niche ŸMetered Dose Inhalers ŸNasal Sprays ŸDry Powder Inhalers We manufacture a complete range of HFA based Metered Dose Inhalers, Nasal Sprays, Topical Aerosols & Dry powder Inhalers for various steroidal & non-steroidal products covering therapeutic applications such as anti inflammatory, anti asthmatic, allergic rhinitis, cardiovascular, pain relief, sore throat, burn relief & others. Ultratech's venturing into MDI s... A strategic initiative! Research & Development Ultratech specializes in developing products that are used in modern health care and which require a high degree of care and foresight. An intelligent team of scientists, R&D and manufacturing chemists are committed to a policy of continuous product and process improvement for the benefit of the customers. Our team constantly provides cost reduction by adopting new methods, process simplification, standardization and technology up-gradation. As a part of R & D; Pilot plant assemblies are installed to carry out production trial runs, facilitating the scaling up of the product from laboratory to commercial scale. Quality Control & Quality Assurance Ultratech believes in implementation of Total Quality Management, hence endeavours to carry out strict QC vigilance in all its manufacturing locations by its in-house, highly trained and competent technical staff to ensure that all products comply strictly to international quality specifications & standards. We have well equipped chemical & instrumental labs with modern & sophisticated instruments such as HPLC, HPTLC, LCMS, GC, IR, UV Spectrophotometers & other instruments. High quality performance standards are achieved through qualified and experienced staff, modern equipment, documented procedures & an established Quality Assurance system. The Quality Assurance team functions independently for monitoring & controlling the various activities of each functional department as pre defined in the S.O.P.'s and authenticated guidelines. Ultratech s Third eye... Total Quality Management

6 Regulatory Compliance Ultratech offers in-house Regulatory support by way of providing CTD dossiers for our range of formulations & Drug Master files for our APIs for obtaining registrations in various countries. Our regulatory competence in obtaining product registrations in many markets highlight our commitment to comply with International Regulatory guidelines. The practices at Ultratech are adherence to cgmp, quality & safety standards. We ensure the compliance of Pharmacopoeial specifications and most of our products are supported with technical packages comprising of Drug Master Files, Complete Product Dossiers, Free sale certificates, Certificate of Pharmaceutical Products and all relevant supporting documents that are required for drug registration globally. Excellence in documentation support generates trust and confidence in our partners Ultratech - Your strategic partner in Formulations, APIs & Drug Intermediates vdevelopment and large scale manufacturing of latest Formulations, APIs & Drug Intermediates vdevelopment of Innovative dosage and packaging forms vstrategic Tie ups for marketing vcustomised Formulation combinations including premixed forms for final manufacturing vjoint Ventures for local packaging and manufacturing at country specific locations from Bulk to finished forms v R&D, Pilot batches to large scale commercial production vtechnology transfers vspecial support in regulatory Dossiers, DMFs, stability, BA & BE studies Global Health Care is our Business... and we mean it!

7 Sales Contacts: Asia Pacific, Australia, North America, Latin & South America sales2@ultratechindia.com Europe, Africa, Middle East, Russia & CIS Countries sales3@ultratechindia.com India sales@ultratechindia.com Other Contacts : info@ultratechindia.com ULTRATECH INDIA LIMITED Regd. Off.: 119, J.K. Chambers, Sector-17, Vashi, New Mumbai , India. Tel : / Fax : info@ultratechindia.com Website :