alexa API Supplier Change or Addition of Alterate API Supplier in Generic Drug Products: Cost, Quality and Regulatory Factors
ISSN : 2153-2435

Pharmaceutica Analytica Acta
Open Access

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API Supplier Change or Addition of Alterate API Supplier in Generic Drug Products: Cost, Quality and Regulatory Factors

Useni Reddy Mallu1*, Arunkanth Krishnakumar Nair1, Hanimi Reddy Bapatu2, Pavan Kumar M3, Santosh Narla4, Jonna Sankar4, Tejas4, Narendra Kumar Thamma4 and NVVSS Raman4

1Department of Chemistry, Sri Krishnadevaraya University, Anantapur, Andhra Pradesh, India

2Department of Chemistry, JNT University, Hyderabad, Andhra Pradesh, India

3Formulation Regulatory Affairs, Laurus Labs Pvt. Ltd, Hyderabad, India

4Hetero Drugs Ltd. (R&D), Balanagar, Hyderabad, Andhra Pradesh, India

*Corresponding Author:
Useni Reddy Mallu
Dept. of Chemistry, Sri Krishnadevaraya University
Anantapur, Andhra Pradesh, India
E-mail: [email protected]

Received date: April 11, 2015; Accepted date: April 28, 2015; Published date: May 05, 2015

Citation: Mallu UR, Nair AK, Bapatu HR, Pavan Kumar M, Narla S, et al. (2015) API Supplier Change or Addition of Alterate API Supplier in Generic Drug Products: Cost, Quality and Regulatory Factors. Pharm Anal Acta 6:364. doi: 10.4172/2153-2435.1000364

Copyright: © 2015 Mallu UR, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.



Generic drug product (GDP) competition for market existence and profitability has become a challenging task for the manufacturers. All the generic players are putting intensive efforts to enter the market with competitive price and consistent drug product (DP) quality. The generic firms have to manage the delicate balance between the cost and quality of raw materials, especially the active pharmaceutical Ingredient (API) for market survival. Major Pharma companies have adopted the merger and acquisition strategies with API manufacturers to withstand the competition and price erosion. Still the majority firms don’t have their own API manufacturing facility. Since the finished product cost is majorily driven by API, the supplier selection plays prominent role in the generic profitability as well as quality. The supplier screening and selection includes extensive evaluation and comparison of documents, quality and cost. As part of risk mitigation strategy many generic manufactures prefer to include additional or alternate sources for API supplier. This exercise could be triggered anytime during the DP life cycle. The authors have tried to share the view on supplier change process at various stages of product lifecycle and related regulatory authority requirements and expectations. Generic products have been targeted majorly for US and Europe regions and same is being focused here. These two regulatory bodies have almost similar requirement for supplier selection and change, except difference in procedural approaches. The regulatory requirements may vary for each phase of generic product life cycle. At the development stage, the supplier change may not significantly fall into regulatory umbrella. Generally development phase comes under relatively less regulatory scruitiny than CTD submission or post approval phase. The dossier review and post approval phase have almost similar regulatory requirements. All the post approval changes shall be routed through SUPAC filing in US and VARIATION filing procedures in Europe.

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