Big News!!! Sun Pharma gets Notice with 10 Obeservation to Halol Unit

Sun Pharma- Notice from USFDA

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As per USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection.

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Sun Pharma- What USFDA Found

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The USFDA conducted a Good Manufacturing Practices (GMP) inspection of the Halol facility from April 26 to May 9, 2022.

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Sun Pharma- Company reponse to USFDA

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For India-based Sun Pharma, it follows a few other manufacturing mishaps in the last year that was one of the greatest news.

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Sun Pharma- Recalls Generic TadalaFil

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"Incorrect grade" of an inactive ingredient was found to have been added during production.

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Sun Pharma- Swipe Up For More!!!

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Sun Pharma- Notice from USFDA

Sun Pharma on Tuesday said the USFDA has issued a 'Form 483' with ten observations after inspecting its Halol-based manufacturing

As per USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection.

Sun Pharma- Form 483

Sun Pharma- What USFDA Found

investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act.

The USFDA conducted a Good Manufacturing Practices (GMP) inspection of the Halol facility from April 26 to May 9, 2022.

Sun Pharma- USFDA GMP Inspection

Sun Pharma- Company reponse to USFDA

The company is preparing the response to the observations, which will be submitted to USFDA within 15 business days.

For India-based Sun Pharma, it follows a few other manufacturing mishaps in the last year that was one of the greatest news.

Sun Pharma- Other Mishaps

Sun Pharma- Recalls Generic TadalaFil

Sun recalled more than 100,000 bottles of its generic tadalafil tablet for erectile dysfunction distributed in the U.S.

"Incorrect grade" of an inactive ingredient was found to have been added during production.

Sun Pharma- Incorrect Grade of Ingredients

Sun Pharma- Swipe Up For More!!!

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