Active Pharmaceutical  Ingredients     
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Contents on the CD Rom

  • 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 (APIís), 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 APIís 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.
 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 ó 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
  • BiDilģ 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

        

Primary Information Services
 21 Murugappan St, SwamyNagar Ext2, 
Ullagaram, Chennai - 600091, India.
 Phone: 91 44 22421080 
Email : informer@eth.net
Mobile numbers:9940043898, 9444008898  Fax : 91 44 22423753