- Active pharmaceutical
ingredients (API) are individual substances or a
mixture of
substances used to produce a drug or medical product. These drug
substances can be manufactured by processes like chemical
synthesis, fermentation and extraction or by recovery from natural
resources.
- API starting materials
are raw materials, intermediates or other APIs that are
incorporated as significant fragments into the API structure.
Starting materials range from chemicals of defined properties and
structure, to blood and plasma, or derivatives.
- The conditions of
buildings and facilities used for manufacturing
intermediates
or APIs may affect the product quality. Room conditions
are critical
factors for drug production, packaging and storage.
- Equipment used in the
manufacture of intermediates and APIs should be
of appropriate
design and adequate size, and suitably located for its
intended
use, cleaning, sanitization (where appropriate), and maintenance.
- Active Pharmaceutical
Ingredients (API’s), used as ingredients in sterile
medicinal
products, must be sterile unless the final dosage form
is
terminally sterilised, or produced by a process including a
sterilising
filtration step.
- The manufacture of
sterile API’s must be strictly controlled in order to
minimize
the risk of contamination with micro-organisms, endotoxins
and
particles.
- The total European API
market was worth $4.5 billion in 2003 exhibiting
an estimated
growth rate of 2.8 per cent. Cardiovascular is the
largest
therapeutic segment accounting for approximately 20
percent of the total
API market. Other major therapeutic
segments include central nervous
system disorder, oncology,
pain management and gastrointestinal.
- The Indian
pharmaceutical industry valued at $12 billion has
portrayed
tremendous progress with reference to infrastructure
development,
technology base creation and a wide range of
production. The
pharmaceutical industry produces bulk drugs
belonging to major therapy
groups. India ranks 4th worldwide
accounting for 8 per cent of the world's
production (in terms
of volume) and 13th in terms of value.
- It is estimated that by
the year 2010, the Indian pharmaceutical industry has the potential to
achieve over Rs. 1,00,000 crore in formulations and
bulk drug
production. The industry now produces bulk drugs belonging
to
all major therapeutic groups requiring complicated
manufacturing process
and has also developed Good Manufacturing
Practices (GMP) facilities for the production of different dosage
forms.
- Indian companies are
proving to be better at developing Active
Pharmaceutical
Ingredients (APIs) than their competitors from target
markets
and that too with non-infringing processes. Indian drugs are either
entering in to strategic alliances with large generic companies in the
world of off-patent molecules or entering in to contract
manufacturing
agreements with innovator companies for supplying
complex under-patent
molecules.
- Active Pharmaceutical
Ingredient manufacturers may have different levels of cleaning
requirements in facilities based on the stage of the process being
cleaned and the subsequent product to be manufactured. It is the
responsibility of the manufacturer to demonstrate that the level of
cleaning and validation performed is adequate based on each individual
situation and on a justifiable scientific rational.
- Ranbaxy started as a
manufacturer of active pharmaceutical ingredients (API) and soon began
looking at international markets for securing these ingredients. In
1977, Ranbaxy established a subsidiary in Nigeria through a joint
venture and in 1984 it expanded operations to Malaysia.
- Indian Pharmaceutical
companies are in a favourable position to develop drugs at a fraction of
the international costs due to the low manpower cost, infrastructure,
quality scientists and the capability to conduct path breaking research.
- Some of the companies
like Dishman Pharma, Divis Labs and Matrix Labs have been undertaking
contract jobs for MNCs in the US and Europe. Even Shasun Chemicals,
Strides Arcolabs, Jubilant Organosys, Orchid Pharmaceuticals and many
other large Indian companies started undertaking contract manufacturing
of APIs as part of their additional revenue stream.
- Top MNCs like Pfizer,
Merck, GSK, Sanofi Aventis, Novartis, Teva etc. are largely depending on
Indian companies for many of their APIs and intermediates. The Boston
Consulting Group estimated that the contract manufacturing market for
global companies in India would touch $900 million by 2010. Industry
estimates suggest that the Indian companies bagged manufacturing
contracts worth $75 million in 2004.
- On the basis of the
pharmaceutical customer base, the European fine chemical industry can be
divided into two sectors: innovative or branded sector and the generic
or unbranded sector. The innovative segment accounts for more than half
of the total API market in Europe followed by generic segment. API
manufacturers for the innovative sector are struggling to identify more
outsourcing opportunities while API manufacturing for the generic sector
is drawing all the attention.
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General and Manufacturing Process
- Active
ingredient
- Active Pharmaceutical
Ingredients Fact Sheet
- Active Pharmaceutical
Ingredients Manufacturing
- Manufacturing,
Processing, or Holding Active Pharmaceutical Ingredients
- Good Manufacturing
Practice guide for Active Pharmaceutical Ingredients
- Manufacture of sterile
active pharmaceutical ingredients
Cleaning
Procedures
- Impurity Profiles in
Active Pharmaceutical Ingredients
- Cleaning Validation in
Active pharmaceutical Ingredient manufacturing plants
- Quantification of
Active Pharmaceutical Ingredients on Metal Surfaces Using a Mid-IR
Grazing- Angle Fiber Optics Probe — An In-Situ Cleaning Verification
Process
- Requirements for
Process Validation of Biotech Active Pharmaceutical Ingredients
Company
Profiles
- Alpharma
- CPL, Inc.,
- Ind-Swift Laboratories
Limited
- J. P. Pharma-chem
Industries
- Kopran
- Lek
- Lupin Ltd.
- Mallinckrodt Active
Pharmaceutical Ingredients
- Orchid Chemicals &
Pharmaceuticals Ltd
- Scientific Protein
Laboratories LLC
- Teva Pharmaceutical
Industries Limited
- Scott Medical
Products
- Index
Pharmaceuticals
- Mahendra
Chemicals
- Prachi Pharmaceuticals
Private Limited
- Sai
Phytoceuticals Pvt. Ltd
- Vishal Pharmakem
- Boehringer Ingelheim
Pharma Chemicals
- Cadila
Pharmaceuticals
- Glenmark
Pharmaceuticals Limited
Consultants
- The CECON Group,
Inc
- DevinderPal &
Associates
- DHG Consultants
- EHS Innovators
LLC
- Intota
- Greenfield
Environmental Consultants Ltd
- PharmOut
- SafeBridge Consultants,
Inc.
Material Safety Data
Sheet
- Alli
- BiDil® Tablets
- Lithium
Carbonate
- Relifex Tablets
- Tygacil
Patent
- Pharmaceutical
materials and methods for their preparation and use
- Process for preparing
tannate liquid and semi-solid dosage forms
- Taste of Active
Pharmaceutical Ingredients
- Compositions and
methods for stabilizing active
pharmaceutical ingredients
- Composition for
percutaneous absorption of pharmaceutically
active ingredients
- Divisible
pharmaceutical tablet with delayed active ingredient
release
- Composition that
consists of alkanedicarboxylic acids and a
pharmaceutical
active ingredient
- Cryogranulation and
Storage Method for Active Pharmaceutical Agents
Technology
- The Use of Process
Analytical Technology in Active Pharmaceutical Ingredient Process
Development
- Technology for New Drug
Deliver y Systems
- Acoustic-resonance
Spectrometry as a Process Analytical Technology for the Quantification
of Active Pharmaceutical Ingredient in Semi-solids
- New Trends in the
Crystallisation of Active Pharmaceutical Ingredients
- Method to Evaluate the
Dustiness of Pharmaceutical Powders
- IMS Detection and
Quantification of Active Pharmaceutical Ingredients for Personal Air
Monitoring
- Innovative treatment of
wastewater containing active pharmaceutical ingredients
- Becoming a Contract
Manufacturer and Combining Active Pharmaceutical Ingredient
Manufacturing and Sterile Liquid Filling
Business
Strategy
- Pharmaceutical supply
chains: key issues and strategies for optimisation
- Indoco Balance
Sheet
- Concerning Integration
of Active Pharmaceutical Ingredients and Fine Chemicals Businesses by
Means of Businesses Separation and Integration to Yoshitomi Fine
Chemicals
- Trade Related Aspects
of Intellectual Property Rights
- Evolvence India: Investment focus &
strategy
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Market
- Experimentation with
strategy in the Indian Pharmaceutical Sector
- Indian Pharmaceutical
Industry: Recent Performance Trend and Developments
- The Polish
Pharmaceutical Market
- Global trends in
Quality Assurance in pharmaceutical ingredients
- Global Active
Pharmaceutical Ingredients Supply Chain
- Manufacturers in the
European active pharmaceutical ingredients market are struggling to
overcome a variety of challenges
- Active Pharmaceutical
Ingredients: Evaluating the Situation in Europe
- India in
Business
- Ind-Swift Laboratories
Limited undergoes successful USFDA audit
- Sources and Prices of
API
Report
- European Conference on
Active Pharmaceutical Ingredients
- FDA Process Inspection
And API Manufacturing
- Building Blocks of
Growth
- Cadila Company
Report
- Lubrizol Completes Sale
of Active Pharmaceutical Ingredient and Intermediate Compounds
Business
- 1st International
Active Pharmaceutical Ingredients EXPO & CONFERENCE
Rules and
Regulations
- Compliance Assistance
Tool for Pharmaceutical Production, Pesticide Active Ingredient
Production, and Miscellaneous Organic Chemical Manufacturing
NESHAP
- Active Pharmaceutical
Ingredient Process Inspection
- Qualified Persons in
the Pharmaceutical Industry
- Regulation of Release
and Absorption of the Active Pharmaceutical Ingredient by the
Formulation of the Drug Product
- Rules on Procedure and
Requirements for the Marketing Authorization for Medicinal Product
Granting
Policy
- Alternate Source of the
Active Pharmaceutical Ingredient in Pending ANDAs
- Principles for
effective regulatory active pharmaceutical ingredients policy
- Policy for the
Importation or Sale of Active Pharmaceutical Ingredients for Veterinary
Use
Projects
- Elimination of Active
Pharmaceutical Ingredient (API) Manufacturing Bottleneck Enables
Technology Development Activity
- Global Active
Pharmaceutical Ingredient (API) Supply Chain Analysis
- Production of Active
Pharmaceutical Ingredient
- Profile of the
Pharmaceutical Manufacturing Industry
- Pharmaceutical
Cluster
Plant
- Alembic Chemicals
Pharmaceutical Plant
- Labochim
- Lifeline Industries
Limited
- Linde Active ingredient plants / Fine chemical
plants
- Novartis Active
Pharmaceutical Ingredients (API) Plant
- Torrent Pharmaceutical
Limited
- Wyckoff Active Pharmaceutical Ingredient
Plant
Suppliers and
Buyers
- List of
Companies
- API
Manufacturers
- Manufacturers and
Wholesalers Directory
- Foreign
Exporters & Manufacturers
- Haorui Pharma-Chem Inc
- Indian
Exporters & Manufacturers
- Selling Leads of
API
- M S Pharmachem
- API Suppliers
- Active Pharmaceutical
Ingredients Manufacturers & Suppliers
- Manufacturers of Active
Pharmaceutical Ingredients
- Active Pharmaceutical
Ingredients and Intermediates
- Active Pharmaceutical
Ingredients Buyers List
- Indian
Importers & Buyers of API
Health
Effects
- Health effects of
exposure to active pharmaceutical ingredients
- Dissolution Study of
Active Pharmaceutical Ingredients Using the Flow Through Apparatus
Usp4
- Effects of Human
Pharmaceuticals on Aquatic Life
- Pharmaceuticals in the
environment
- Green Pharmacy:
Preventing Pharmaceutical Pollution
- Quality of Active Pharmaceutical
Ingredients
Products and
Guides
- API Products
List
- Univar Products
List
- Hamburg Products
List
- Guideline on Active
Pharmaceutical Ingredient Master File
- Guidelines for
Selecting Active Pharmaceutical Ingredient Suppliers for a US-based
Pharmaceutical Manufacturer
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