Presence of Indian Pharmaceutical Industries in US Market: An Empirical Analysis

2009 ◽  
Vol 6 (4) ◽  
pp. 333-344 ◽  
Author(s):  
Jena Deepak Kumar ◽  
Vishwajeet Mohan ◽  
Padmanabhuni Venkata Appaji ◽  
Lanka Srinivas ◽  
Poduri Balaram
Keyword(s):  
Drug Application ◽  
Active Pharmaceutical Ingredient ◽  
The United States ◽  
The Us ◽  
Pharmaceutical Industries ◽  
Export Destination ◽  
Complex Chemistry ◽  
New Drug Application ◽  
Total Type ◽  
Comprehensive Study

The United States is the largest pharmaceutical market in the world with generic sales accounting for US$58.5 billion and is India's largest export destination. India accounts for one out of every four Abbreviated New Drug Application (ANDA) approvals in the years 2007 and 2008, ranks first in total Type II active Drug Master Files (DMFs) with US Food and Drug Administration and it also received 31 per cent of all tentative approvals (as on 11 December 2008). In 2008, the exports of formulations from India to top 28 regulated countries surpassed Active Pharmaceutical Ingredient (API) exports firmly demonstrating the shift in credibility and Quality Compliance. India has rich vendor base with 3.75 DMFs per molecule and has filed more than 450 different APIs. Has India tapped the US market to its fullest potential? Where do the opportunities for further growth for India lies in this market? To answer this question, a comprehensive study of DMFs and ANDAs filings by their therapeutic categories, dosage forms, strengths, companies, countries and other key parameters like patents was undertaken. The study reveals that ANDAs from India are confined to small number of highly competitive molecules, and has to move into the new orbit of working in complex chemistry, Biotech-based medicines, and advanced formulations.

scholarly journals FDA relations during drug development

2000 ◽  
Vol 2 (3) ◽  
pp. 213-217
Keyword(s):  
Drug Development ◽  
Drug Application ◽  
Development Program ◽  
The United States ◽  
Legal Aspects ◽  
Development Programs ◽  
New Drug ◽  
Regulatory Affairs ◽  
New Drug Application ◽  
Drug Development Program

Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs. In the United States, the drug development team includes not only members of the key disciplines of drug discovery, clinical research, regulatory affairs, marketing, chemistry, toxicology, and legal aspects, but also the Food and Drug Administration (FDA). New regulations encourage meetings at the pre-investigational new drug (pre-IND), end-of-phase-2, and pre-new drug application (pre-NDA) submission phases. Appropriate informal discussions via fax and telephone are also encouraged. By proactively interacting with the FDA, the pharmaceutical industry increases the probability of a successful drug development program.

Abbreviated New Drug Application Process: A Gift for The Industry and The Patients

2021 ◽  
pp. 331-335
Author(s):  
Hindustan Abdul Ahad ◽  
Haranath Chinthaginjala ◽  
Gangireddy Jayasimha Reddy ◽  
Pasupuleti Dheeraj Krishna ◽  
Syed Rahamathulla ◽  
...  
Keyword(s):  
Drug Application ◽  
The United States ◽  
New Drugs ◽  
Brand Name ◽  
Application Process ◽  
Drug Products ◽  
Federal Food ◽  
United States Food ◽  
States Food ◽  
New Drug Application

The United States Food and Drug Administration (USFDA) is one of the main regulated agencies wherein the submission and approval of the new drugs is done. This review is based on the process of submission to the ANDA as per FDA norms as described in paragraph IV submission in Federal Food, Drug, and Cosmetic Act (FD and C Act). No drug would exist in the market until it gets accepted by regulatory authorities. The ANDA submission is for those firms seeking to copy branded drugs before running out of patents to get profit on them. A generic applicant must provide in its application a "certification" that a patent submitted to FDA by the brand-name drug's sponsor and scheduled in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). A Generic Product must meet the standards recognized by FDA in Reference listed drugs (RLD). This study concludes the process of ANDA submission to FDA and acts correlated to the submission in paragraph IV, the details of ANDA filling in the eCTD format and overview of the review process the checklist to the applicant.

An Examination of the Drug Review Process Within the United States

1994 ◽  
Vol 13 (2) ◽  
pp. 121-142 ◽  
Author(s):  
Phillip A. Johns
Keyword(s):  
Drug Development ◽  
Development Time ◽  
Review Process ◽  
Drug Application ◽  
The United States ◽  
New Drugs ◽  
Total Drug ◽  
Scientific Approach ◽  
New Drug Application ◽  
Drug Review

A general overview of the drug review process is presented with emphasis on non-clinical approaches for gaining acceptable exemptions for investigational use of new drugs. Selected non-clinical requirements for approval of marketing or the new drug application are also discussed. Particular attention is given to the trend towards a more rational, scientific approach to the design of studies that are intended to elucidate issues of safety and efficacy. The fundamental purpose of these new approaches is to reduce drug development time and expense and bring newer and better drug therapies to patients. Newer requirements for the conduct and use of kinetics earlier in development are emphasized. The relevance of meetings with the Food and Drug Administration and the effects that meetings are reported to have had on total drug development time are also discussed.

scholarly journals Competition among China and ASEAN-5 in the US Market: A New Extension to Shift-Share Analysis

2019 ◽  
Vol 3 (4) ◽  
pp. 129-137
Author(s):  
He Shuquan
Keyword(s):  
United States ◽  
The United States ◽  
The Philippines ◽  
Export Growth ◽  
The Other ◽  
The Us ◽  
Static Approach ◽  
Asean Countries ◽  
Negative Impacts ◽  
Export Destination

The United States has a robust trade and investment relationship with China and the Association of Southeast Asian Nations (ASEAN). ASEAN is collectively the fourth-largest trading partner, and China is one of the largest trade partners of the United States, the largest export destination for China. Thus, China and ASEAN countries are competing in the US market intensively. The purpose of this paper is to calculate the net gains or losses for the ASEAN-5 Members and China during 1993 and 2007 in the US market. There are two main contributions of this paper: one is to dynamically estimate the net shifts of the economies as compared to the traditional comparative static approach; the other is to extend the shift‐share analysis to attribute the net gains or losses to competing exporters. This study adopts the widely used shift-share analysis technique to exam the net gains or losses for the ASEAN-5 and China during 1993-2007 in the Unites Sates market. The paper provides a new extension to the shift‐share analysis to attribute the net shift to competing economies with a dynamic approach. The paper applies the methodology to the competition among China and ASEAN-5 in the US import market with the data drawn from World Integrated Trade Solution (WITS), a data consultation and extraction software developed by the World Bank. The discussion focuses on three periods: 1993-1997, 1998-2002 and 2003-2007. In general, China performs the best among the competing economies. Among the ASEAN-5 Indonesia, Malaysia and Thailand perform better than the other two members. During the first period, all economies have positive export growth as the actual export growth shows. However, in terms of net shift, only China and the Philippines are the winners with positive value of net shifts. During the second period, China stands out while the ASEAN economies show negative net shifts values. Similar is the case for the third period. In terms of the industries, China focuses on different industries during the thee periods, and the ASEAN economies depend heavily on a few industries. China’s gains in these industries are much bigger than the ASEAN economies’ gains in value. The ASEAN economies gain in small numbers of industries with small values. When attributed the gains or losses to competing economies, China only loses to the Philippines during 1993-1997, and gains from all competing economies during all periods. Though net losers, the ASEAN-5 also gain from other competing economies. For example, Indonesia gains from Singapore and Thailand during 1993-1997, from the Philippines and Singapore during 1998-2002, from Malaysia, the Philippines and Singapore during 2003-2007. The trade war between the United States and China provides opportunity for the ASEAN countries in the Unites Sates market, however, there are negative impacts on the ASEAN countries as well. The ASEAN countries are more vulnerable. Keywords: shift-share analysis, export competitiveness, Asia, ASEAN, China.

scholarly journals REVIEW ON SPONSOR / APPLICANT MEETINGS WITH FDA: HIGHLIGHTS OF NEW GUIDANCE OVER EXISTING

2018 ◽  
Vol 4 (2) ◽  
pp. 19-26
Author(s):  
Charmy Kothari ◽  
Kavina Shah
Keyword(s):  
Clinical Trials ◽  
Management Practices ◽  
Drug Application ◽  
Development Program ◽  
The United States ◽  
United States Department ◽  
Biological Products ◽  
New Drug ◽  
License Application ◽  
New Drug Application

The United States Department of Health and Human Services has a federal agency called the Food and Drug Administration (FDA or USFDA). A pre-planned assembling of two or more people who have been together for the purpose of getting a common goal via verbal interaction is called a formal meeting. During development stage of any drug or biological products pharmaceutical companies face trouble for both scientific and regulatory point of view, here role of formal meetings comes. Formal meetings between sponsor or applicant and FDA are usually related to development and review of drug and biological products. Center for Drug evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regulates the formal meetings. These meetings are applicable to Pre – Investigational New Drug Application, Pre – Biologics License Application, New Drug Application for drugs and biological products and not applicable to Abbreviated New Drug Applications (ANDA), application of medical devices and submission of biosimilar biological products. Meetings between FDA and sponsor or applicant are for resolution of dispute, clinical holds discussion, Assessment of protocols of clinical trial, during clinical trials, in between clinical trials – at the phase 1 ending or at the phase 2 ending, to discuss development program. The FDA has classified these formal meetings in different types based on the nature of the request, the information in the meeting request and each meeting type is handled through different procedures. The principles of Good Meeting Management Practices (GMMPs) must be maintained. There are specific requirements and procedures to request, prepare, schedule, conduct and document formal meetings. As the guidance documents for meetings are revised by FDA, Change in procedure and requirements takes place. Any pharmaceutical company need to be in line with new guidance requirements to avoid rejection. Formal meetings between sponsor or applicant and FDA save time, cost and will increase the probability of product approval.

scholarly journals Has Generalized System of Preferences Scheme Influenced Nepalese Exports to the United States? An Empirical Analysis

2016 ◽  
pp. 29-39
Author(s):  
Ganga Ram Bhandari
Keyword(s):  
United States ◽  
Empirical Analysis ◽  
New Products ◽  
The United States ◽  
Generalized System ◽  
Generalized System Of Preferences ◽  
The Us ◽  
Export Destination ◽  
The Impact ◽  
Liberal Policy

This paper attempts to evaluate the impact of generalized System of Preferences (GSP) scheme on exports of Nepal to the United States (US). Nepal-US trade is very crucial because the US is still the second largest export destination of Nepal. Thus, it is pertinent to study exports of Nepal to the US under GSP scheme. Empirical results show that impact of GSP scheme is very minimal and negative. Other factors than liberal policy viz. GSP determines exports of Nepal to the US. Weakening exports capacity and declining trade transaction of Nepal to the US is of major concern. In this regard, to sustain the export of existing but declining exportable items like garment, carpet, pashmina and handicrafts and development and promotion of GSP eligible new products and services will only be the resolution of this obstruction.Economic Journal of Development Issues Vol. 17 & 18 No. 1-2 (2014) Combined Issue, Page: 29-39

Analyzing United States Prescribing Information to gain insight into FDA-sponsor discussions

1969 ◽  
Vol 17 (3) ◽  
Author(s):  
Iraj Daizadeh
Keyword(s):  
United States ◽  
Drug Development ◽  
Drug Application ◽  
The United States ◽  
Data Repository ◽  
Fda Approval ◽  
New Drug Application ◽  
Development Paradigm ◽  
Prescribing Information ◽  
Insight Into

The United States Prescribing Information (USPI) is a key vehicle for communicating the benefit-risk information of a Food and Drug Administration (FDA) approved prescription drug. The USPI is typically the last step of the drug development process and requires discourse between the FDA and the sponsor for a new drug application. The USPI may also be updated after obtaining FDA approval. As a social artifact of industry and FDA discussions, it is hypothesized that an analysis of a library of USPI records may yield insight into this dialog. Here, an analysis of DailyMed – a USPI data repository – reveals that structural language similarities (linguistic typologies) exist across USPI. Interestingly, these typologies describe labeling language that may not be explicitly described in FDA regulatory documentation. It is proposed that the methodology herein proposed may be leveraged to potentially facilitate USPI development and FDA dialogue (and therefore expedite the drug development paradigm). Several examples are used to showcase the approach. A discussion on limitations of the methodology and opportunities for development is also presented.

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