Pharmaceuticals suppliers

Figure 3.4b Number of pharmaceutical suppliers and retail pharmacies ...

Rofecoxib was withdrawn from the market worldwide in September 2004 by the pharmaceutical supplier because of a reported high... 

U.K. IQA (1994) Pharmaceutical Supplier Code of Practice Covering the Manufacturing of Pharmaceutical Raw Material, Active Ingredients and Excipiants, Document Reference No. P00020, Issue 2, Institute of Quality Assurance, Pharmaceutical Quality Group. 

This can be more complicated, since it will rely on the assessment of a company s potential ability, separate from the actual context of historical performance. Ideally any new supplier should be certificated to a national or international quality standard (e.g. ISO 9000), with an already audited and proven quality system. (During the 1990s many UK packaging companies have been independently certificated to the Pharmaceutical Supplier Codes of Practice, which are linked to ISO 9002.)... 

Pharmaceutical Supplier Code of Practice (obtained via Institute of Quality Assurance, London.) (i) The manufacture of printed materials for use in the packaging and labelling of medicinal products (document reference P00021). (ii) The manufacture of medicinal product contact packaging materials (document reference P00022). 

It should be noted that the volume resulting from the use of blister and strips will be more significant in the warehousing activities of the pharmaceutical supplier and the wholesaler. It will probably be less critical than the community pharmacist envisages, since lower stock levels of OPDs are likely to be kept compared with a bulk pack of 500, 1,000, etc., and the dispensing containers which have to be kept for their use. An actual reduction in space could occur as cartons stack better than bottles, particularly if the bottles are not contained in cartons. 

Pharmaceutical Supplier—Code of Practice (UK), The Manufacture of Pharmaceutical Raw Materials (British Standard Institute of Quality Assurance—Pharmaceutical Group). 

Florida-Pharmaceutical Wholesaler Reform legislation along with Walmart s RFID mandate for pharmaceutical suppliers coupled with California s pedigree law moves forward. 

The Association of British Pharmaceutical Industry (London), publishes a Directory of Members, while the British and Overseas Pharmacist s Year Book (London, British and Colonial Druggist Ltd.) provides an alphabetical list of manufacturers and gives information on schools of pharmacy in many countries and institutions. The Chemist and Druggist Diary and Yearbook (Morgan) lists pharmaceutical suppliers, has a trade names index and also provides information on societies and institutions. The Pharmaceutical Society publishes annually an Index of New Products which gives the names and addresses of manufacturers with some technical information, while similar data with a list of trade names is given in the London Medical Handbook (British and Colonial Druggist Ltd.). Manufacturers are also listed alphabetically in the Proprietary Articles Trade Association Yearbook, and in the Retail Chemist Trade Price List of Proprietary Articles (London, Drury Press) which contains a list of trade names. British Chemical Plant (British Chemical Plant Manufacturers Association) lists its members. 

Vitamin A is manufactured by Hoffmaim-La Roche (Switzerland), BASF (Germany), and Rhc ne-Poulenc (France), as well as by some smaller suppliers in India, China, and Russia. The worldwide production is estimated to be 2500 to 3000 metric tons. About three-quarters of this production is for animal feed the remainder is for food fortification and pharmaceuticals (qv). The main trade names of feed products are Rovimix, Lutavit, and Microvit. Prices depend on appHcation forms and are approximately 60— 70/10 lU retinol (1995) ie, 200— 233/10 RE. One lU is equivalent to 0.300 )lg of aH-Zra/ j -retinol and 1 RE is equivalent to 1 ) g of all-retinol. 

In addition to the building parameters, there are often some requirements from suppliers of processes and equipment to make sure their parts function properly. This may mean that the requirements for the equipment decide the target levels (e.g., in pharmaceutical and electronics industries). In other cases there are restrictions on deviations from the target levels (e.g., on temperature for machine control system or on humidity and vibration for optical measure nient systems). ... 

An organization of the generic drug industiy in the US., representing generic pharmaceutical manufacturers, distributors and their suppliers. 

This work is presented in two voiumes. The arrangement within the books is aiphabetic by generic name. The tabie of contents appears at the beginning of Volume 1. There is also an index by trade names used in many of the countries in the world. Another index lists the raw materials used in the manufacture of the various drugs, an index which should be commercially valuable to suppliers of chemical raw materials to the pharmaceutical industry. These indexes appear at the end of Volume 2. 

So far, no scientific extrapolation has been published on the cost savings for the chemical industry when using micro reactors. Industrial experience is also not known at least, it has not been communicated. Thus, one is boimd to rely on expert opinions given in the press and trade press. Mostly these come from suppliers of the technology, aiming to convince industry of the benefits of their systems, by prognosis of a return on investment. Considering the pharmaceutical R D efforts of the order of US 50 billion worldwide, CPC/Mainz sees a potential for an increase in profit of more than US 15 billion if micro reactors are implemented consequently [246]. 

The Promochem Group was the first international specialist supplier of certified reference materials (CRMs) and pharmaceutical reference substances used in environmental, medical and trace element analysis. Their experience provides a viewpoint that echoes, reinforces and expands on many of the trends discussed above (Jenks 1997). From the middle of the 1980 s, sales of CRM by Promochem increased between 10 % and 20 % annually, depending on the market sector and application. Since then National and International Metrology Institutes, such as the now privatized U.K. Laboratory of the Government Chemist (LGC), the European and U.S. Pharmacopoeias, the E.U. IRMM and others have recognized that efficient distribution of RMs, backed by available technical support, is as important as production and certification. Thus, they have moved to spread their influence outside their national origins. The Web and e-commerce will continue to grow as major facilitators of better information dissemination and supply of CRMs. 

In the design of equipment for the manufacture of sterile ophthalmic (and nonophthalmic) pharmaceuticals, manufacturers and equipment suppliers are turning to the advanced technology in use in the dairy and aerospace industries, where such concepts as CIP (clean-in-place), COP (clean-out-of-place), automatic heliarc welding, and electropolishing have been in use for several years. As a guide here, the reader is referred to the so-called 3A Standards of the dairy industry issued by the U.S. Public Health Service [267],... 

Some gum users now take gum in a pre-prepared form. Spray dried gum acacia has been used in pharmaceutical products for some time. The spray dried gum offers the pharmaceutical manufacturer a clean ready to use product. Instant forms of gum acacia have been offered by suppliers for some time. The instant products can be rapidly made into solution and used. Obviously the instant gum is more expensive. A manufacturer that uses gum as a minor ingredient may well find that the capital and labour cost of purifying raw gum is not cost effective. A company that uses gum acacia as a major ingredient might come to a different conclusion. Instantised gums pose different problems to the analytical chemist.. One approach that can be used is to have an optical rotation specification for the product. Even this approach is not entirely proof against a material that contains a blend of gums of different optical rotation. 

Obviously, in a relatively small work such as this it is not possible to be comprehensive. Preparations of bulk, achiral materials (e.g. simple oxiranes such as ethylene oxide) involving key catalytic processes will not be featured. Only a handful of representative examples of preparations of optically inactive compounds will be given, since the emphasis in the main body of this book, i.e. the experimental section, is on the preparation of chiral compounds. The focus on the preparation of compounds in single enantiomer form reflects the much increased importance of these compounds in the fine chemical industry (e.g. for pharmaceuticals, agrichemicals, fragrances, flavours and the suppliers of intermediates for these products). 

Quality still remains the No. 1 criteria for any outsourcing activity. Imports from third-party suppliers account for greater than 80% of APIs (active pharmaceutical ingredient) in the United States and 40% of medicinal products, yet the FDA (US Food and Drug Administration) continues to conduct far fewer foreign compared to domestic inspections (Mullin, 2011). Contaminated heparin was judged as the cause of 81 deaths in the United States in 2008. FDA traced the contaminated API to a Chinese supplier (Changzhou SPL Co.). 

In some cases, compounds are purchased from laboratories or other suppliers. The collections of various compounds are called libraries, and libraries of large pharmaceutical organizations have from hundreds of thousands to millions of compounds. For example, the Developmental Therapeutics Program... 

Examined factors were organic solvent concentration, buffer or electrolyte concentration, - - buffer or electrolyte pH,7 7 - T83,85,86 voltage,chiral selector concentration " and supplier, active pharmaceutical ingredient (API) concentration, internal standard concentration, injection time - and pressure, ... 

Theoretical calculations can also provide physicochemical data, which can be used as an input for 3D-QSAR correlation studies [134,141]. There is a current trend in the area of lead-finding in the pharmaceutical industry to use calculations to set up computer search profiles to be used in the screening of large structural databases, such as the chemical suppliers databases and the internal company databases. 

Presented together by the British, European, Japanese, and U S. Pharmacopeias, the first Interpharmacopeial Open Conference on Standards for Excipients was convened in Orlando, FL, from January 30-February 1, 1991 (Table 1). Attended by 165 participants, representation included 11 countries, 59 pharmaceutical or excipient manufacturers or suppliers, three regulatory agencies (FDA, EEC, and HPB), and seven pharmacopeias (the presenters and the French, Italian, and Spanish Pharmacopeias) [17]. In preparation for this conference, USP convened open meetings on Magnesium Stearate and Lactose attended by almost every major manufacturer from Europe and the United States. 

Tablets and capsules Pharmaceutical ingredients Purified water Manufacturing environment Products Periodic after history is established accepted on supplier certificate of analysis Loop daily and taps weekly Quarterly Periodic after history is established due to low water activities of tablets and capsules...

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