guideline for apis manufacturers and exporters in india
DESCRIPTION
Manufacturers should conduct regular reviews over produced APIs and pass it to exporters. So the exporters can describe the quality of products to the buyers more specifically.TRANSCRIPT
Good APIs manufacturing Guide
Created by : APIs Exporters - AdaniPharm
Adani Pharma Chemicals
APIs Manufacturers in India
Created by : APIs Exporters - AdaniPharm
Manufacturing and safety of administered drugs iscontrolled by government agencies assuringconsistent quality in products.
For more than a decade, FDA center isencouraging pharmaceutical industries to use
latest tools &
technologies for manufacturing drugs as permarket trends.
Government Agency - FDA
Created by : APIs Exporters - AdaniPharm
Latest technologies not only help in improving
• Product quality
• Lead to Innovations and
• Reducing overall drugs costs.
Latest Research
Created by : APIs Exporters - AdaniPharm
According to latest research manufacturingprocesses in pharmaceutical industries is still laggingas compared to other industrial areas.
When you will focus on reasons they are quiteunderstandable.
What is the Reason?
Created by : APIs Exporters - AdaniPharm
No one is interested in implementingpharmaceutical manufacturing processes especiallywhen they are under
• Clinical trials and
• Revalidations by industries can be trulyexpensive.
It is also not easy to commercialize new APIs anddrugs in market.
Created by : APIs Exporters - AdaniPharm
What is the Market Trend?
According to market trends, pharmaceuticalindustries are continuously striving to improvemanufacturing processes in India.
It is also intended to help ensure that APIs meetthe requirements for quality and purity that theypurport or are represented to possess.
Created by : APIs Exporters - AdaniPharm
How to control Cost while Innovation?
“Manufacturing” is defined to include alloperations of :
• Receipt of materials,
• Production,
• Packaging,
• Repackaging,
• Labelling,
• Relabelling,
• Quality control,
• Release,
• Storage and distributionof APIs and the relatedcontrols.
Created by : APIs Exporters - AdaniPharm
How to control Cost while Innovation?
At the same time, pharmaceutical industries areworried that innovative manufacturing process costswill be high.
Costs is also not the main reason, people are notcomfortable with changes.
They are currently earning huge profits withpresently 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
At the same time, pharmaceutical industries areworried that innovative manufacturing process costswill be high.
Costs is also not the main reason, people are notcomfortable with changes.
They are currently earning huge profits withpresently employed tools and technologies. Honestly,they don’t feel any need to change.
How to control Cost while Innovation?
Created by : APIs Exporters - AdaniPharm
Utmost Care and Safety
Manufacturing drugs with utmost care and safetyis an art.
API manufacturers in India are using finechemicals for excellent pharmaceutical value.
These controls are inherent responsibilities of themanufacturer 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 theyare released into market.
Only safe and profitable deals are offered tocustomers.
FDA wants pharmaceutical industries to employlatest tools and technologies for more robustproduction.
Created by : APIs Exporters - AdaniPharm
FDA recommends latest technology use
Continuous improvements are required inpharmaceutical industries for fast development andreliable manufacturing.
Buildings and facilities used in the manufacture ofintermediates and APIs should be located, designed,and constructed to facilitate cleaning, maintenance,and operations as appropriate to the type and stageof manufacture.
Created by : APIs Exporters - AdaniPharm
Reliable Drug Deals
General engineering and basic chemistry conceptsare applied for developing valuable pharmaceuticalproducts.
Economical benefits are also there, we just needto capitalize them.
To know more on reliable drug deals, you candiscuss 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 : [email protected]