You are here: Home » Companies » News
Business Standard

Aurobindo's Unit-3 gets Form 483 with six observations

Aurobindo has six formulations manufacturing facilities in India, one each in the US and Brazil.

BS Reporter  |  Hyderabad 

Aurobindo Pharma

Limited's formulations manufacturing facility at Bachupally in Hyderabad has received with six observations.

The US Food and Drug Administration (FDA) had issued the observation letter after conducting an inspection at unit-III during April 10-18, 2017.

"The observations are all on procedural improvements. None of them are related to data integrity. The company will be responding as per the prescribed time lines," Aurobindo informed the stock exchanges on Wednesday.

The issues to a pharma company at the end of inspection if it finds any violation of the Food Drug and Cosmetic Act. The company should respond to the with a corrective action plan and then implement that expeditiously.

Aurobindo has six formulations manufacturing facilities in India, one each in the US and Brazil. The Bachupally unit is an exclusive multi-product oral dosage form facility spread over 40,469 sq m for non-cephalosporins and non-beta-lactams.

 

RECOMMENDED FOR YOU

Aurobindo's Unit-3 gets Form 483 with six observations

Aurobindo has six formulations manufacturing facilities in India, one each in the US and Brazil.

BS Reporter Hyderabad, 19 AprilAurobindo Pharma Limited's formulations manufacturing facility at Bachupally in Hyderabad has received Form 483 with six observations.The US Food and Drug Administration (FDA) had issued the observation letter after conducting an inspection at unit-III during April 10-18, 2017."The observations are all on procedural improvements. None of them are related to data integrity. The company will be responding as per the prescribed time lines," Aurobindo informed the stock exchanges on Wednesday.The USFDA issues Form 483 to a pharma company at the end of inspection if it finds any violation of the Food Drug and Cosmetic Act. The company should respond to the form 483 with a corrective action plan and then implement that expeditiously.Aurobindo has six formulations manufacturing facilities in India, one each in the US and Brazil. The Bachupally unit is an exclusive multi-product oral dosage form facility spread over 40,469 sq m for non-cephalosporins and ...

Limited's formulations manufacturing facility at Bachupally in Hyderabad has received with six observations.

The US Food and Drug Administration (FDA) had issued the observation letter after conducting an inspection at unit-III during April 10-18, 2017.

"The observations are all on procedural improvements. None of them are related to data integrity. The company will be responding as per the prescribed time lines," Aurobindo informed the stock exchanges on Wednesday.

The issues to a pharma company at the end of inspection if it finds any violation of the Food Drug and Cosmetic Act. The company should respond to the with a corrective action plan and then implement that expeditiously.

Aurobindo has six formulations manufacturing facilities in India, one each in the US and Brazil. The Bachupally unit is an exclusive multi-product oral dosage form facility spread over 40,469 sq m for non-cephalosporins and non-beta-lactams.

 

image
Business Standard
177 22

Aurobindo's Unit-3 gets Form 483 with six observations

Aurobindo has six formulations manufacturing facilities in India, one each in the US and Brazil.

Limited's formulations manufacturing facility at Bachupally in Hyderabad has received with six observations.

The US Food and Drug Administration (FDA) had issued the observation letter after conducting an inspection at unit-III during April 10-18, 2017.

"The observations are all on procedural improvements. None of them are related to data integrity. The company will be responding as per the prescribed time lines," Aurobindo informed the stock exchanges on Wednesday.

The issues to a pharma company at the end of inspection if it finds any violation of the Food Drug and Cosmetic Act. The company should respond to the with a corrective action plan and then implement that expeditiously.

Aurobindo has six formulations manufacturing facilities in India, one each in the US and Brazil. The Bachupally unit is an exclusive multi-product oral dosage form facility spread over 40,469 sq m for non-cephalosporins and non-beta-lactams.

 

image
Business Standard
177 22