Description: Exploratory Study on Active Pharmaceutical Ingredient Manufacturing for Essential Medicines

Exploratory Study on Active Pharmaceutical Ingredient Manufacturing for Essential Medicines

Active Pharmaceutical Ingredients (API) of good quality is core to the manufacturing of effective and safe essential drugs. The price of APIs is the main cost driver for manufacturing. Only a limited number of large manufacturers of finished pharma...

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Bibliographic Details
Main Authors:	Bumpas, Janet, Betsch, Ekkehard
Language:	English en_US
Published:	World Bank, Washington, DC 2013
Subjects:	ACTIVE INGREDIENTS ACTIVITIES ADVERTISING ANALGESICS ANTIBIOTICS ANTIMALARIALS AUDITS BARRIER TO ENTRY BARRIERS TO ENTRY BID BRAND BRANDS BROKERS BUDGET CAPACITY BUILDING CAPITAL BASES CAPITAL INVESTMENT CAPITAL REQUIREMENT CAPITAL REQUIREMENTS CAPSULES CERTIFICATION CHECKS CHILDREN CHLOROQUINE RESISTANCE CHRONIC DISEASES COMMERCIAL MARKETS COMMODITIES COMMON MARKET COMPANIES COMPANY COMPETITION COMPETITIVE MARKETS COMPETITIVENESS COMPETITORS CONTAMINATION CONTESTABILITY CONTRACT CONTRACTS CORPORATION COUNTRY RISK COURSE OF THERAPY CURRENCY DEMAND DEMAND FORECASTING DEPRECIATION DERIVATIVES DEVELOPING COUNTRIES DEVELOPING COUNTRY DIFFERENTIAL PRICING DIRECT COSTS DOMINANT FIRMS DONOR DONOR FINANCING DONORS DRUG EVALUATION DRUG MARKETS DUE DILIGENCE EFFICIENT MARKET ENTERPRISE EQUIPMENT ESSENTIAL DRUGS EXCHANGE EXCHANGE RATES EXPANSION EXPORT MARKETS EXPORTERS FAIR FAIR PRICE FINANCING FINISHED PRODUCT FIRM FIRMS FOREIGN CURRENCY FUTURE GENERIC DRUGS GLOBAL ECONOMY GLOBAL MARKET GMP GOOD GOOD MANUFACTURING PRACTICES GOODS GRANT HEALTH CARE HUMAN DEVELOPMENT IMMUNIZATION INTELLECTUAL PROPERTY INTELLECTUAL PROPERTY RIGHTS INTERFERON INTERNATIONAL BANK INTERNATIONAL COMMERCE INTERNATIONAL FINANCE INTERNATIONAL MARKET INTERNATIONAL STANDARDS INVESTING INVESTMENT ISONIAZID LABORATORIES LACK OF TRANSPARENCY LAWS LEGAL COUNSEL LOCAL GOVERNMENT LOCAL MANUFACTURERS LOCAL MARKET MANUFACTURER MANUFACTURERS MARKET MARKET ECONOMY MARKET ENTRY MARKET INFORMATION MARKET PRICE MARKET PRICES MARKET SEGMENT MARKET SHARE MARKET SHARES MARKET SIZE MARKET STRUCTURES MARKET TRANSPARENCY MARKETING MARKETPLACE MARKETS MEDICINE MNC MONITORING MULTINATIONAL MULTINATIONAL CORPORATION OIL PRICES OPEN MARKET OPTION OPTIONS PACKAGING PARTIES PARTNER PARTNERS PAYMENT TERMS PHARMACEUTICAL PHARMACEUTICAL INDUSTRY PHARMACEUTICAL INSPECTION PHARMACEUTICAL MANUFACTURERS PHARMACEUTICAL MANUFACTURING PHARMACEUTICAL PRODUCTION PHARMACEUTICAL PRODUCTS PHARMACEUTICAL SECTOR PHARMACEUTICAL TECHNOLOGY PHARMACEUTICALS PHARMACY PLANNING PLEDGES POOLED PROCUREMENT PORTFOLIO PORTFOLIO MANAGEMENT PREDATORY PRICING PREPAYMENT PRICE PRICE COMPETITION PRICE QUOTATIONS PRICE VOLATILITY PRICES PRICING PRICING SCHEMES PROCUREMENT PRODUCT PRODUCT QUALITY PRODUCTS PROFIT PROFIT MARGIN PROFIT MARGINS PUBLIC HEALTH PURCHASING QUALITY ASSURANCE QUININE REGULATORY AUTHORITIES REGULATORY AUTHORITY REGULATORY CAPACITY REGULATORY STANDARDS RETURN REVENUES SALES SECURITY SEE STATE OWNED ENTERPRISES STORE SUPPLIER SUPPLIERS SUPPLY SUPPLY CHAIN SUPPLY CHAIN MANAGEMENT TABLETS TARGET MARKET TECHNICAL ASSISTANCE TECHNICAL SUPPORT TENDERING TRADING TRANSACTION TRANSACTION COSTS TRANSACTIONS TRANSFER PRICE VACCINES VALUE WORKING CAPITAL WORLD MARKET
Online Access:	http://documents.worldbank.org/curated/en/2009/09/11809103/exploratory-study-active-pharmaceutical-ingredient-manufacturing-essential-medicines http://hdl.handle.net/10986/13682

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Summary:	Active Pharmaceutical Ingredients (API) of good quality is core to the manufacturing of effective and safe essential drugs. The price of APIs is the main cost driver for manufacturing. Only a limited number of large manufacturers of finished pharmaceutical products have their own API manufacturing capabilities, and none of them can make all required APIs in-house. The majority of manufacturers, including all those located in Sub-Saharan Africa (with the exception of one company in South Africa) have to buy all APIs in the open market. The paper tries to make the structures of the API market more transparent, trying to determine how difficult it is for small manufacturers in developing countries to navigate the global API market and ensure that they get a quality product at a fair price. It also looks into the competitiveness of the market, trying to assess the risk that manufacturers or traders monopolize parts of the API market for essential medicines with low commercial attractiveness. The author confirms the initial assumption that the API market provides a challenge in particular to small manufacturers, who have limited means to verify the quality of the APIs they are buying. One potential way to address this problem would be to broaden the World Health Organization (WHO) prequalification system to include APIs for drugs that are on the WHO model list for essential medicines.

Exploratory Study on Active Pharmaceutical Ingredient Manufacturing for Essential Medicines

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