1.Introduction 2.API sourcing 3.API sourcing in other Countries 4.Regulatory filing 5.DMFs 6.Regulatory Guideline for API 7. Compression study of active pharmaceutical ingredients in different countries 8.Filling issue

1. Presented by:
PRAKHAR VARSHNEY
M pharm (1st SEM)
College of pharmacy
TMU, Moradabad (U.P)

2. CONTENTS
1.Introduction
2.API sourcing
3.API sourcing in other Countries
4.Regulatory filing
5.DMFs
6.Regulatory Guideline for API
7. Compression study of active pharmaceutical ingredients in different
countries
8.Filling issue
9.References

3. 1. Introduction
 Active Pharmaceutical ingredients (APIs) play an important role in the drug product
industry. The most obvious contribution is that the API is the active ingredient that
makes a drug product effective and provide the pharmacological activity of any
drug product or dosage form.
 Historically many APIs used to produce drug product in the united state by the
dosage forms manufacture were made in the United State either by contactor or by
the owner of the drug product NDA or ANDA.

4. 2. API sourcing
 APIs can be manufactured using a number of different method and techniques.
 Naturally derived APIs are usually extracted from natural source and purify for use
in drug products.
 Chemically synthesized compound
 Compound derived from fermentation isolated and purifieA combination of any of
the techniques

5. 3. API sourcing in other countries
 As the API industry has continued to expand in other areas of the world, other
country and regions have developed their own review and filling process as well
as compliance program.
For example : The European union has strengthened its processes associated with
APIs and now requires API GMP compliance within its directive.
However, regulatory review and inspectional processes very significantly. In some
Countries, APIs can gain regulatory approval simply by being published in an
official compendium.

6. 4. Regulatory Filings
What is needed to get regulatory approval for drug product varies around the
World. However, some form of
 NDA
 ANDA
 NADA (New animal drug application)
 Dossiers (The term commonly used for the earlier terms inside the United
State)
 DMF

7. 5. DMFs
DMFs are commonly used as a way to provide confidential or Proprietory
information about an API to a regulatory agency such as the FDA. A DMF normally
includes:
 Information about manufacturing and control
 Facility and process information used to produce or quality control an API,
 Synthesis descriptions or detailed process information, and
 Manufacture site location and facility /equipment usage.

8. 6. Regulatory Guideline for APIs
 In order to obtain a marketing authorisation for a drug product the applicant has
to show evidence of efficacy, safety and quality of the drug product
 Different countries have different procedure For regulatory filling for API, In U.S it
has done as per DMF procedure of FDA while in Europe it is done by Active
substance master file (ASMF) procedure.
 The older and off patent APIs have an alternative assessment system called as
the ‘’Certification of suitability’’(CEP). It is used Pharmacopoeia Convention.

9. 7. Compression study of active pharmaceutical ingredients in different countries

10. 8. Filling issues
 The name of the compound
 The API structure and molecular weight
 A detailed full description of the synthesis, biological process, or extraction
process used to produce the API
 Facility and process description
 All raw materials, solvents, catalysts used
 Identify the API SM (starting material)
 Impurities
 Impurity profile
 Reprocessing step
 Water quality identified
 The in process and final product control used to assure the quality of the API
 A sample batch record
 The specification for the API ingredient and raw materials
 Identification of the manufacture of the API, its supplier to key raw materials
intermediate or other purchase material
 Stability data
 Address of the manufacture of the API and all purchased intermediates
 Definition of the container (clouser system).