Exploratory Study on Active Pharmaceutical Ingredient Manufacturing for Essential Medicines
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World Bank, Washington, DC
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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.
Palabras clave
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