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Exploratory Study on Active Pharmaceutical Ingredient Manufacturing for Essential Medicines

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Author(s)
Bumpas, Janet
Betsch, Ekkehard
Keywords
PRICING
COMPETITORS
PORTFOLIO MANAGEMENT
OPEN MARKET
PARTNERS
REVENUES
EFFICIENT MARKET
WORKING CAPITAL
LOCAL MARKET
PHARMACEUTICAL SECTOR
PLEDGES
PARTIES
BRAND
INTERNATIONAL BANK
INTERNATIONAL FINANCE
INTELLECTUAL PROPERTY RIGHTS
FINANCING
MARKET TRANSPARENCY
FINISHED PRODUCT
PROFIT
BARRIER TO ENTRY
INTERNATIONAL MARKET
BARRIERS TO ENTRY
ANALGESICS
MARKET INFORMATION
AUDITS
TENDERING
CAPITAL BASES
PHARMACEUTICAL PRODUCTION
CAPITAL REQUIREMENT
CAPITAL REQUIREMENTS
GOOD MANUFACTURING PRACTICES
MONITORING
OIL PRICES
REGULATORY CAPACITY
FIRMS
ANTIBIOTICS
DEVELOPING COUNTRY
BRANDS
MARKET ECONOMY
VALUE
FIRM
DOMINANT FIRMS
INTERNATIONAL COMMERCE
PHARMACEUTICAL INDUSTRY
DEVELOPING COUNTRIES
TRANSACTION
CONTAMINATION
MARKET PRICE
TECHNICAL ASSISTANCE
CHLOROQUINE RESISTANCE
MARKET ENTRY
REGULATORY AUTHORITIES
CAPITAL INVESTMENT
PREDATORY PRICING
DRUG MARKETS
SUPPLIERS
COURSE OF THERAPY
LEGAL COUNSEL
ACTIVITIES
CAPACITY BUILDING
CONTRACT
PROCUREMENT
INTERFERON
PHARMACY
EXPANSION
PACKAGING
PAYMENT TERMS
PHARMACEUTICAL MANUFACTURING
PHARMACEUTICAL TECHNOLOGY
MARKET STRUCTURES
OPTION
PORTFOLIO
MULTINATIONAL
SUPPLY CHAIN MANAGEMENT
SECURITY
BID
MARKET
LABORATORIES
GLOBAL MARKET
DRUG EVALUATION
PRODUCT QUALITY
EXCHANGE
INTELLECTUAL PROPERTY
MARKETS
PHARMACEUTICAL MANUFACTURERS
EXCHANGE RATES
HEALTH CARE
MARKET PRICES
FUTURE
ANTIMALARIALS
MANUFACTURER
MEDICINE
MULTINATIONAL CORPORATION
DUE DILIGENCE
SEE
DONOR FINANCING
DIFFERENTIAL PRICING
COMPETITION
PROFIT MARGINS
PHARMACEUTICAL PRODUCTS
COMMODITIES
PHARMACEUTICAL
PREPAYMENT
TRADING
ACTIVE INGREDIENTS
PURCHASING
PRICE COMPETITION
CONTESTABILITY
SUPPLIER
TRANSACTIONS
CHRONIC DISEASES
PUBLIC HEALTH
POOLED PROCUREMENT
LAWS
COUNTRY RISK
DEMAND
CORPORATION
COMPANY
DONOR
MNC
PRICE QUOTATIONS
ESSENTIAL DRUGS
ADVERTISING
CERTIFICATION
EXPORTERS
WORLD MARKET
GMP
TARGET MARKET
DIRECT COSTS
PRODUCT
SUPPLY
REGULATORY AUTHORITY
CURRENCY
IMMUNIZATION
GLOBAL ECONOMY
PRICING SCHEMES
COMMON MARKET
MARKET SIZE
CHECKS
MANUFACTURERS
MARKET SEGMENT
COMMERCIAL MARKETS
TABLETS
INVESTING
PRODUCTS
CHILDREN
PHARMACEUTICAL INSPECTION
QUALITY ASSURANCE
TRANSACTION COSTS
VACCINES
COMPETITIVENESS
LOCAL MANUFACTURERS
CONTRACTS
FAIR PRICE
CAPSULES
SUPPLY CHAIN
PROFIT MARGIN
BROKERS
GRANT
MARKET SHARES
MARKET SHARE
PARTNER
EXPORT MARKETS
INTERNATIONAL STANDARDS
DEPRECIATION
PHARMACEUTICALS
BUDGET
OPTIONS
FAIR
PLANNING
PRICE
EQUIPMENT
GOODS
LOCAL GOVERNMENT
DEMAND FORECASTING
TRANSFER PRICE
STORE
COMPANIES
MARKETPLACE
PRICES
LACK OF TRANSPARENCY
QUININE
ENTERPRISE
GOOD
PRICE VOLATILITY
TECHNICAL SUPPORT
COMPETITIVE MARKETS
INVESTMENT
DERIVATIVES
HUMAN DEVELOPMENT
ISONIAZID
RETURN
REGULATORY STANDARDS
MARKETING
FOREIGN CURRENCY
SALES
STATE OWNED ENTERPRISES
DONORS
GENERIC DRUGS
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URI
http://hdl.handle.net/20.500.12424/95618
Online Access
http://hdl.handle.net/10986/13682
Abstract
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.
Date
2013-05-30
Type
Publications & Research :: Working Paper
Identifier
oai:openknowledge.worldbank.org:10986/13682
http://hdl.handle.net/10986/13682
Copyright/License
CC BY 3.0 IGO
Collections
Corruption and Transparency Collection

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