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Understanding the effect of API changes in pharmaceutical processing Private

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The work not only demonstrates that the input API size was impacted by the process, but that by characterising the API particle characteristics one could understand the mechanism of the change. This improved understanding of the intermediate API/blend characteristics could be applied to subsequent processing steps, removing the requirement to rely on the input particle characterisation data.

Subsequent work4 utilised the measured API attrition to determine the location of attrition events within the feed system. These efforts applied the understanding of the process/API interaction in order to develop a better elucidation of the unit process and to investigate the impact of varying process conditions on the extent of attrition. The study demonstrated how changes in the feed screw speed could alter the extent of attrition; increased feed rates resulted in increased levels of attrition. This raises an interesting issue; for such unit processes the feed system is often utilised as part of the automated feedback control to maintain the intermediate product characteristics, but if by changing the feed system we alter the blend characteristics, the tool used to control process variation could be a significant source of said variation.

Active pharmaceutical ingredients (APIs) refer to vital chemicals that are responsible for making the drug work. Depending on type, biotech/biological API, synthetic chemical API, high-potency API, plant extracts API, and classical fermentation API are some of the products available in the active pharmaceutical ingredients (API) market.

Analysts at TMR emphasize that the global active pharmaceutical ingredients (API) market will show promising growth on the back of increase in number of abbreviated new drug applications (ANDA. This aside, the market will gain advantage of growing focus on government bodies toward biomedical innovation.

Key Findings of Active Pharmaceutical Ingredients (API) Market Report

In recent years, the active pharmaceutical ingredients (API) market is experiencing remarkable growth in demand for cost-effective drug substitutes. Several vendors engaged in the pharmaceutical drug manufacturing do not have adequate in-house capacity to fulfill this stupendous growth in demand. This situation has resulted in increased number of active pharmaceutical ingredients (API) producers. This scenario shows that the active pharmaceutical ingredients (API) market will grow at rapid pace in the upcoming years.

DEFINITION OF ACTIVE PHARMACEUTICAL INGREDIENT (API)

i.The guideline encompasses the APIs of new products for registration and current / existing registered products. This is applicable to all pharmaceutical products (excluding traditional products, veterinary products, and health supplement products) both locally manufactured and imported.
ii. Biological active substances and immunological active substances are excluded from the scope of this guideline. Please refer to relevant guidelines available for Biologics.
iii. APIs used in products for export only (FEO) are exempted from the requirement for submission of the Drug Master File (DMF) and Certification of Suitability (CEP) in the product application.
iv. The API information required as in this guideline is only applicable for final APIs and not intermediate API

v. Separate registration of the APIs is not a requirement for the purpose of product registration. However, the required technical documentation pertaining to each API should be submitted with the new product registration application.
vi. Assessment of an API will be performed once submission of a new product registration application has been done.
vii. Assessment of an API will also be performed for a registered product prior to a product renewal application.

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