Guideline for apis manufacturers and exporters in india

Adani Pharma Chemicals Good APIs manufacturing Guide

Created by : APIs Exporters - AdaniPharm

APIs Manufacturers in India  Manufacturing and safety of administered drugs is controlled by government agencies assuring consistent quality in products.  For more than a decade, FDA center is encouraging pharmaceutical industries to use  latest tools &  technologies for manufacturing drugs as per market trends.

Created by : APIs Exporters - AdaniPharm

Government Agency - FDA  Latest technologies not only help in improving • Product quality • Lead to Innovations and • Reducing overall drugs costs.

Created by : APIs Exporters - AdaniPharm

Latest Research ď ą According to latest research manufacturing processes in pharmaceutical industries is still lagging as compared to other industrial areas. ď ą When you will focus on reasons they are quite understandable.

Created by : APIs Exporters - AdaniPharm

What is the Reason?  No one is interested in implementing pharmaceutical manufacturing processes especially when they are under • Clinical trials and • Revalidations by industries can be truly expensive.  It is also not easy to commercialize new APIs and drugs in market.

Created by : APIs Exporters - AdaniPharm

Created by : APIs Exporters - AdaniPharm

What is the Market Trend? ď ą According to market trends, pharmaceutical industries are continuously striving to improve manufacturing processes in India. ď ą It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.

Created by : APIs Exporters - AdaniPharm

How to control Cost while Innovation?  “Manufacturing” operations of :

• • • • •

is

Receipt of materials, Production, Packaging, Repackaging, Labelling,

defined

to

include

all

• Relabelling, • Quality control, • Release, • Storage and distribution of APIs and the related controls.

Created by : APIs Exporters - AdaniPharm

How to control Cost while Innovation?  At the same time, pharmaceutical industries are worried that innovative manufacturing process costs will be high.  Costs is also not the main reason, people are not comfortable with changes.  They are currently earning huge profits with presently employed tools and technologies. Honestly, they don’t feel any need to change.

Created by : APIs Exporters - AdaniPharm

How to control Cost while Innovation?  At the same time, pharmaceutical industries are worried that innovative manufacturing process costs will be high.  Costs is also not the main reason, people are not comfortable with changes.  They are currently earning huge profits with presently employed tools and technologies. Honestly, they don’t feel any need to change.

Created by : APIs Exporters - AdaniPharm

How to control Cost while Innovation?

Created by : APIs Exporters - AdaniPharm

Utmost Care and Safety  Manufacturing drugs with utmost care and safety is an art.  API manufacturers in India are using fine chemicals for excellent pharmaceutical value.  These controls are inherent responsibilities of the manufacturer and are governed by national laws.

Created by : APIs Exporters - AdaniPharm

FDA tests All Drugs before Released  Drugs are closely tested by FDA team before they are released into market.  Only safe and profitable deals are offered to customers.  FDA wants pharmaceutical industries to employ latest tools and technologies for more robust production.

Created by : APIs Exporters - AdaniPharm

FDA recommends latest technology use ď ą Continuous improvements are required in pharmaceutical industries for fast development and reliable manufacturing.

ď ą Buildings and facilities used in the manufacture of intermediates and APIs should be located, designed, and constructed to facilitate cleaning, maintenance, and operations as appropriate to the type and stage of manufacture.

Created by : APIs Exporters - AdaniPharm

Pharmaceutical Buildings

Reliable Drug Deals  General engineering and basic chemistry concepts are applied for developing valuable pharmaceutical products.  Economical benefits are also there, we just need to capitalize them.

 To know more on reliable drug deals, you can discuss with API manufacturers in India right away.

Created by : APIs Exporters - AdaniPharm

Created by Adani Pharma Chemicals Phone : +91-2827-287165 / 640131 / 32/33/34 Fax : +91-2827-287166 Email : exports@adanipharma.com