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Merlin Powder Characterisation

Logo Merlin Powder Characterisation
  • Formulation development and drug delivery
  • Human Medicines
  • Worldwide

We provide scientific support to tablet formulation industries.  We can help in a number of ways, for example: -Characterising the compression characteristics of new materials and excipients.  Knowing how they behave greatly increases the speed at which a sucessful formulation can be developed. -Scale up predictions. Using development scale samples, we can determine how likely the formulation will be to sucessfully scale up to full speed production and the conditions under which capping and lamination could occur.  Valuable information which can save time and money by avoiding the wrong formulations early. - Generate quantitative data for QbD purposes - Trouble shoot existing production problems to understand the route cause and identify possible solutions. - Increase your scientific undertanding of how your formulation compressess under controlled conditions. - Onsite training and conference presentations are also possible. We achieve this through the use of a hydraulic Compaction Simulator for compression,  Schulze RST-XS shear cell for flow characterisation and years of experience in the field. More »

Basi

  • Contract manufacturing, filling and packaging
  • Human Medicines
  • Europe, South America, Asia, Australia & New Zealand, Middle East, Africa, Worldwide

. BASI LABORATORIES | Laboratórios Basi - Indústria Farmacêutica, S.A. (Portugal) Basi is a leading privately-owned Portuguese Pharmaceutical company, which initiated its activity in 1956, dedicated to the development, manufacture and marketing of medicines and other health products that have had the opportunity to register a strong growth since 2007, coupled with profound organisational restructuring and new strategic direction which aimed, among other objectives, the broadening of its product portfolio, offering today to its partners, the medical community and general population, therapeutic solutions in more than 50 different areas, meeting the highest standards of quality with the most competitive cost possible. . FAST GROWING PRODUCT PORTFOLIO Basi Labs has been committed to counting in its portfolio the most required medicines by the health system but also other high-value formulations, pursuing both established as well as first-to-file opportunities. With more than 250 pharmaceutical projects registered in 50 different therapeutic areas and a great amount in development and registration, Basi markets and distributes products in a vast number of countries, mainly in Europe, Middle East and Africa (EMEA). Our product pipeline is filled by selections from internally developed medicines (oral liquids and semisolids), in-licensed products (all dosage forms), strategic partnerships with attentive portfolio acquisitions, sustaining a broad range of established and leading molecules for the treatment of many conditions in the fields of Anti-Infectivity; Neurology; Cardiology; Respiratory; Oncology; Blood disorders; Genitourinary; Gastroenterology; Bones, Muscles and Joints; Allergy and includes a vast list of other health products such as food supplements, biocides, medical devices and dermocosmetics. . CONTRACT MANUFACTURING AND PACKAGING For over 50 years, we have been working with companies trading in pharmaceuticals (originators and generic) and other health products around the globe, expanding their product lines and providing more cost-effective alternatives for manufacturing their products. We offer excellent expertise in technical transfer of products into our facility. Basi develops and manufactures: - Oral Liquids (solutions, suspensions, syrups); - Semisolid formulations for Topical use (gels, creams, ointments, lotions, solutions, sprays) and Suppositories. In addition to these dosage forms, Basi has fully autonomous and complete manufacturing lines for outer packaging other dosage forms. . OUR SUPPORT SERVICES - QUALITY CONTROL: Basi’s Quality Control has gained international reference, being sourced by numerous international companies for its services. We perform Contract QC testing, EU QP release and Stability. - PHARMACEUTICAL DEVELOPMENT: Basi ensures efficient product development from the first laboratory formulation through to full-scale production, having fully integrated development and production processes, involving our Regulatory Affairs team during the R&D phase to ensure that regulatory aspects are considered from the outset so that registration runs as smoothly and swiftly as possible. - REGULATORY SUPPORT: Our Regulatory Affairs team helps you to clear all of the hurdles on the journey to regulatory approval. We advise on the most effective regulatory approval strategy for each individual product in each individual market – be it a medicinal product or any health product. . WE OFFER: . 1) Out Licensing + Supply cost-effective Finished Product opportunities (with state-of-the-art ready-to-fill EU CTD dossiers) for ORAL LIQUIDS and SEMI-SOLIDS FOR TOPICAL USE: . > AVAILABLE PRODUCTS (RECENTLY REGISTERED IN EUROPE): >> Oral liquids: * Paracetamol – Syrup 4%, Oral suspension 4% | Generic * Bromhexine – Syrup 0.08%, Syrup 0.16% | Generic * Carbocisteine – Syrup 5% | Generic * Ambroxol – Syrup 3%, Syrup 6% | Generic >> Semi-solids for topical use: * Terbinafine – Cream 1% | Generic * Tioconazole – Cream 1% | Generic * Clotrimazole – Cream 1%, Cutaneous Solution 1% and Vaginal Cream 1%| Generic * Isoconazole – Vaginal Cream 1% | Generic * Hydrocortisone – Cream 1% | Generic * Betamethasone – Ointment 0.1% | Generic * Diclofenac – Gel 1% | Well established use or Generic * Etofenamate – Gel 5%, Gel 10%, Cut. Spray 10%, Cut. emulsion 10% | Generic * Methyl salicylate – Ointment 6% | Well established use * Paracetamol – Suppositories 125mg, 250mg and 500mg | Well established use * Glycerol – Suppositories 0.6g, 1g, 2g | Well established use . > LATE STAGE OF DEVELOPMENT - READY FOR SUBMISSION in 2013/2014: >> Oral Liquids: * Simeticone – Oral emulsion 10,5% | Well established use * Lactulose – Syrup 66.7% | Well established use * Nystatin – Oral suspension 100000 U.I./ml | Well established use * Ascorbic acid (Vit.C) – Oral solution (drops) 100 mg/ ml | Well established use * Ibuprofen – Oral suspension 2%, Oral suspension 4% | Well established use * Acetylcysteine – Syrup 2%, Syrup 4% | Well established use * Dextrometorphan – Syrup 0.133%, Syrup 2% | Generic * Desloratadin – Oral solution 0.05% | Generic >> Semi-solids for topical use: * Diclofenac – Cutaneous spray 4% | Generic * Nimesulide – Gel 3% | Generic . 2) Contract Manufacturing and Packaging Basi offers a newly inaugurated State of the Art EU GMP approved production facility with 5000m2 dedicated to the Manufacturing of ORAL LIQUIDS and SEMI-SOLIDS with the utmost competitive costs for every market: - Oral Liquids (solutions, suspensions, syrups); - Semisolid formulations for Topical use (gels, creams, ointments, lotions, solutions, sprays) and Suppositories. In addition to these dosage forms, Basi has fully autonomous and complete manufacturing lines for outer packaging other dosage forms. . 3) Extensive quality Portfolio (>200 EU registered products) available for Partners interested in distributing and marketing our products in Africa (all continent), Middle East, C.I.S. Countries, WBC, Latin America and Australia: - Our product pipeline includes a broad range of established and leading molecules for the treatment of many conditions in the fields of Anti-Infectivity; Neurology; Cardiology; Respiratory; Oncology; Blood disorders; Genitourinary; Gastroenterology; Bones, Muscles and Joints; Allergy and includes a vast list of other health products such as food supplements, biocides, medical devices and dermocosmetics. . 4) Expert Support Services in Regulatory Affairs: Our Regulatory Affairs team helps our partners to clear all of the hurdles on the journey to regulatory approval. We advise on the most effective regulatory approval strategy for each individual product – be it a medicinal product or any health product. Our highly experienced pharmaceutical professionals: - Compile up-to-date application dossiers and registration documents acc. the latest EU directives and specifications in eCTD/NeeS; - Plan and manage National and EU registration procedures (such as MRPs or DCPs), as best suiting customer’s intentions; - Address assessment reports and deficiency letters from registration authorities; - Compile CMC (Chemistry Manufacture Control) data packages for variations; - Plan and organize bioequivalence studies in collaboration with Contract Research Organisations (CROs). . . Our main interests at the moment are: 1) Out Licensing + Supply In house manufactured products (liquid and semi-solids) all over the EU; 2) Contract Manufacturing with the most cost effective alternatives for all Liquid and Semi-solid Dosage forms; 3) Contract Manufacturing with the most cost effective alternatives for all Large Volume Parenterals (separate manufacturing plant); 4) Partnering with companies interested in Distributing and Marketing our Extensive Quality Portfolio in Africa (all continent), Middle East, C.I.S. Countries, WBC, Latin America and Australia. . .  - For the list of Products ready to Out-license all over Europe pleae click here; -  For the full list of Basi's Portfolio (more than 250 pharmaceutical products registred in EU and many more products available for other markets - please contact our BD Department - bd.basi@basi.pt). . . . . SPECIAL PROJECT being developed during 2013:   Laboratórios Basi have been recently granted Marketing Authorisation in PT, BE, BG, CZ, DE, EE, HU, LU, LV, MT, PL, RO, SI and UK ,from a Decentralised Procedure (DCP), for the generic OTC medicinal product Paracetamol, 40 mg/ml (200 mg/5 ml), Oral Suspension, and we are now starting to look for a business partner interested in marketing this product in one or the complete set of Member States involved. Using this MA Dossier Basi can also run DCP duplicates or start a National Procedure in any of the countries, as best suiting your requirements.   Please CLICK HERE for the complete Brochure of the product with the full set of characteristics, from which we would like to highlight the following characteristics: Generic OTC medicine which can be promoted through general public and health care professionals, under any Trademark desired; Formulation designed for children acceptability with sweet orange flavour; No artificial colours; EU certified 5 ml oral syringe for maximum dosage control and easy to administer (no spills); Safe strength suitable for children of all ages of the number 1 prescribed drug in paediatrics! In many EU countries this paediatric strength has an important market share, under several trademarks. The generic product we propose, besides the very attractive price, presents some new marketable features, enabling our partners to introduce in the market a very competitive product!   You are welcome to inform us on your interest in this special project. Please direct all of your queries to bd.basi@basi.pt. . . CONTACT US TODAY: Laboratórios Basi - Indústria Farmacêutica, S.A. Parque Industrial Manuel Lourenço Ferreira, lote 15 3450-232 Mortágua - Portugal Phone: +351 231 920 250 | Fax: +351 231 921 055 | Mobile: +351 914 609 741 Email: bd.basi@basi.pt URL: www.basi.pt . More »

Lipa Pharmaceuticals Limited

Logo Lipa Pharmaceuticals Limited
  • Contract manufacturing, filling and packaging
  • Biopharmaceuticals
  • North America, Asia, Australia & New Zealand

The company is Australia's leading contract manufacturer of Complementary Healthcare medicines. We supply more than 40% of the Australian market, across a wide range of herbal medicines, vitamins and nutritional supplements. We also produce non-sterile prescription and OTC medicines. The company has grown substantially, since we were first established as a family business in 1995. We now operate a facility with over 15,000 sq m under one roof, which combines production plants, laboratories, warehousing and administration offices. The TGA-licensed facility is world class, utilising the highest standards of equipment and technology that can produce Tablets, 2 piece hard-shells, powders, liquids, creams and a variety of Soft Gelatin capsules. We currently employ about 400 people at Minto, in all aspects of our business. The company maintains a strict quality assurance process, which conforms to the requirements of the Australian Code of Good Manufacturing Practice for Medicinal products. Quality Control comprises a chemistry laboratory, in-process quality control laboratory and micro laboratory to ensure all products are manufactured to the highest quality.  The facility also houses a full range of product Stability rooms under ICH conditions. More »

RSM Enterprises

Logo RSM Enterprises
  • Formulation development and drug delivery
  • Biopharmaceuticals
  • Asia

We are one of the reliable exporters and suppliers of wide range of Pharmaceutical Bulk Drugs. We also offer personalized solutions to our clients at reasonable prices. More »

Arlak Biotech Pvt Ltd

Logo Arlak Biotech Pvt Ltd
  • Formulation development and drug delivery
  • Biopharmaceuticals
  • Asia

We are engaged in formulating various Tablets that are used to cure many ailments. Available in different compositions; our tablets comprise of exact concentration of the active ingredients. These are known for their high efficacy and have minimal side effects. More »

Khandelwal Laboratories Pvt. Ltd.

Logo Khandelwal Laboratories Pvt. Ltd.
  • Formulation development and drug delivery
  • Biopharmaceuticals
  • Asia

Khandelwal Laboratories Pvt. Ltd. manufactures and markets pharmaceutical formulations. More »

Bio-Med Private Limited

Logo Bio-Med Private Limited
  • Contract manufacturing, filling and packaging
  • Human Medicines
  • Asia

Bio-Med embarked on its noble mission of producing world-class vaccines essential to the needs of a developing country. India, with its tropical climate is quite prone to a number of diseases that sometimes assumed epidemic proportions in the past. More »

Aristo Pharmaceuticals Ltd.

Logo Aristo Pharmaceuticals Ltd.
  • Formulation development and drug delivery
  • Biopharmaceuticals
  • Asia

To support the medical profession in promoting and preserving good health. That has been the driving force behind Aristo since its inception in 1971. More »

Zhebei Pharmaceutical Co., Ltd.

Logo Zhebei Pharmaceutical Co., Ltd.
  • Contract manufacturing, filling and packaging
  • Biopharmaceuticals
  • Asia

Zhejiang Zhebei Pharmaceutical Co., Ltd. is specialized in the manufacture of nucleoside antiviral drugs and cardioascular drugs. As the backbone medium-sized pharmaceutical enterprise in Zhejiang province, the company has 7 manufacturing shops and tow production based for APIs and preparations. More »

Tergus Pharma

Logo Tergus Pharma
  • Pharmaceutical process development and validation
  • Human Medicines
  • North America

Tergus Pharma is based in Research Triangle Park (RTP) North Carolina.  In its state of the art facilities, Tergus provides complete topical product development services utilizing in-vitro penetration models and other scientific tools. Founded in 1994, Tergus Pharma has been providing quality product development, validation and other analytical services to the pharmaceutical and biotechnology industries. More »

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