In the list of human basic needs, medical needs are one of the top. And India is leading in the field of pharmaceuticals with numerous multinational pharmaceutical companies. Intas Pharmaceuticals is one of these big pharmaceutical giants. They have played a significant role in the growth of the pharmaceutical industry in India. Recently a search term is getting popular “FFR Intas”. FFR(Field of Failure Request) when terms like this are attached to any pharmaceutical then the matter is concerning. We’ll discuss all about this FFR intas and the warning letter they received from CDER and all about their reputation.
What does FFR Intas mean?
FFR stands for (Field of Failure Request). This is a process designed to address and rectify issues which arise when products have unexpected failures and malfunctions. This procedure involves a systematic analysis of failure. Collection of data and take corrective actions to enhance the product reliability. FFR Intas means product failure or violation of guidelines in the manufacturing facility of Intas Pharmaceutical. And they received a warning letter from CDER on November 21, 2023.
Introduction of Intas Pharmaceuticals
Pharmaceuticals Limited a Indian multinational company of Pharmaceuticals. Their headquarter is in Ahmedabad. They produce generic therapeutic drugs and engage in contract clinical research and manufacturing. Intas has 22 manufacturing plants. 17 are in India and the rest in Greece, United Kingdom and Mexico. They have a good reputation in the international pharmaceutical market. In the financial year of 2019, 69% of the company’s revenue came from the international market, 31 % from India.
Details about the Warning letter Intas Received
On November 21, 2023 CDER sent a warning letter to Intas Pharmaceutical about the inspection on their manufacturing facility. The inspection was conducted by the (FDA) Food and Drug Administration. The USFDA inspection Intas’s manufacturing facility from 22 November to 2 December, 2022.
What’s in the letter
FDA has noted violation of data integrity and good manufacturing practices at Intas pharmaceutical’s plant In Ahmedabad.
- USFDA observed that Intas failed to ensure that the product was manufactured with the CGMP guidelines.
- Failed to provide data about their medicines. About the quality of medicine produced at manufacturing facilities.
- Intas failed to follow the required laboratory control mechanism.
Letter had briefly discussed the observation by the inspection team. And Asked Intas Pharmaceutical in 15 working days. They concluded that unavailability of data on medicines means that medicines are adulterated.
Where to Find Original copy of letter
The letter was issued by CDER which is a division of the FDA. So you have to access their website www.fda.gov. you’ll find the warning letters in the featured section of their menu. You can search https //newffr.intaspharma.com/intas ffr the warning letter issued by its number. the letter no. 320-24-12 issued to Intas.
Response Of Intas Pharmaceuticals on warning letter
FDA found the response of Intas pharmaceutical was inadequate. And failed to explain their actions. FDA further Instructed them to take corrective actions.
Reputation of Intas Pharmaceuticals
Reputation of Intas could be a topic of debate. Is it good or not. They received mixed reviews and criticism.
- Intas got 3.5 stars out of 5 from 437 anonymous employee reviews according to ‘Glassdoor’. A review says that the company is not good for personal growth and knowledge.
- Intas also got two warning letters from USFDA. They got both letters in 2023.
- Auditors have found that Intas haven’t followed proper tests procedures and provide data about their medicines.
- As of June 2022 Intas have 3% market share and ranked 7th in the Indian pharmaceutical market.
FFR Intas login
Intas recently launched a website for their employees to make reporting more accurate and easy. newffr.intaspharma is the domain name of the website. It is a cloud based platform for collection of data from wide range. intasffr login is simple employees just have to fill their user name and password.
Conclusion
This FFRintas inciddent is really concerning for pharmaceutical field. Specially, for Indian phamaceutical. We often gets news of adulterations of medicines. It’s quite frequent from recent few years. And as India is leading in the field of pharmaceuticals. Government have to give these issues more concerns to maintain the reputation as a leader in international pharmaceutical market.
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