Para-4 filing is a common practice in the Indian pharmaceutical industry due to several reasons:
1. *Regulatory framework*: India's regulatory framework allows for Para-4 filings, which enables companies to leverage existing data and research to fast-track the approval process.
2. *Cost-effective*: Para-4 filings are less expensive compared to conducting full-scale clinical trials, making it an attractive option for Indian pharmaceutical companies.
3. *Faster market entry*: Para-4 filings enable companies to enter the market quickly, which is essential in the competitive Indian pharmaceutical market.
4. *Access to global markets*: Para-4 filings can be used to support registrations in other countries, making it easier for Indian companies to expand globally.
5. *Limited resources*: Some Indian companies may not have the resources or expertise to conduct full-scale clinical trials, making Para-4 filings a more feasible option.
6. *Government incentives*: The Indian government offers incentives for companies that develop and manufacture drugs domestically, which encourages Para-4 filings.
Para-4 filing refers to the submission of an abbreviated new drug application (ANDA) that relies on the safety and efficacy data of a reference drug (already approved by the regulatory authority) to support the approval of a generic version. This approach allows Indian pharmaceutical companies to leverage existing data to fast-track the approval process.
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