USFDA issues OAI notice for Torrent Pharma’s Indrad facility in Gujarat.
In response to this notice, Torrent Pharma has clarified that it will not impact this facility’s existing supplies or revenues. (OAI notice for Torrent Pharma)
This manufacturing facility produces formulations and active pharmaceutical ingredients (API) with an annual capacity of 30 million vials. The pharma major revealed that this notice was issued after the USFDA inspected the company’s manufacturing facility and issued Form 483 with three observations.
Torrent Pharma has received the USFDA’s  inspection classification OAI for the company’s Indrad facility in Gujarat.
Per the OAI notice for Torrent Pharma, regulatory or administrative action is recommended by the FDA. The pharma company often gets the regulatory body’s clearance after implementing these recommendations.
About Torrent Pharma
Torrent Pharma is a multinational pharmaceutical company based in India. The company was founded by Shri U. N. Mehta in 1959 and is part of the Torrent Group. It is one of the leading pharmaceutical companies in India, with headquarters in Ahmedabad, Gujarat. It has a strong presence in domestic markets and also strong presence in more than 30 countries across the world. The company manufactures a wide range of products in therapeutic areas such as cardiovascular, central nervous system, gastrointestinal, diabetology, anti-infective, and dermatology. It also produces active pharmaceutical ingredients and biopharmaceuticals.
Know the Abbreviations:
1. USFDA- United States Food and Drug Administration
The United States Food and Drug Administration (USFDA) is a federal agency of the United States Department of Health and Human Services. It is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and ensuring the safety of food supply, cosmetics, and products that emit radiation.
The FDA also evaluates the safety of new drugs and medical devices before they can be sold in the US. They also assess the safety of ingredients used in cosmetics, such as color additives and preservatives. Finally, the FDA monitors the safety of food products, including meat and dairy products, to protect the public from foodborne illnesses.
2. OAI- Official Action Indicated.
The action indicated in pharmaceuticals would depend on the specific situation. For instance, if a medication is found to have adverse effects, the pharmaceutical company may be required to issue a recall or withdrawal of the drug. Additionally, the company may be required to provide warnings or instructions to healthcare providers or to develop and implement a risk management plan. In cases of fraud or misconduct, the company may be required to take disciplinary action against those responsible or to submit a corrective action plan to the relevant regulatory agencies.
The action indicated in pharmaceuticals can vary depending on the situation. Some examples of action indicated may include: 1. Developing and implementing a risk management plan. 2. Monitoring the safety and efficacy of drugs on the market. 3. Ensuring the accuracy and integrity of clinical trial data. 4. Investigating and responding to adverse event reports. 5. Developing and implementing safety measures to detect and prevent counterfeiting of medications. 6. Developing and maintaining a drug recall system. 7. Ensuring the quality of drug manufacturing and labeling. 8. Monitoring the marketing and promotion of drugs. 9. Developing and enforcing regulations and standards for drug distribution. 10. Ensuring adherence to Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP).
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