Sun Pharmaceutical Industries (SPIL) has appointed AAC Consultancy Group Inc, an international consultancy, for implementing good manufacturing practices at its joint venture in the US, Caraco Laboratories.
The move follows the US Food and Drug Administration's (USFDA) warning of serious violation of the Federal Food, Drug and Cosmetic Act of the US by Caraco.
SPIL holds a 48.54 per cent stake in Caraco. R K Baheti, vice-president, finance, SPIL said: "We have appointed AAC to implement all necessary systems and documentation procedures as instructed by USFDA. All these procedures are almost over and currently waiting for formal nod from USFDA."
AAC is a leading international consultancy which provides full range of support and assistance to industries regulated by the USFDA and similar international agencies.
The consultancy firm is qualified to work with large corporations and smaller businesses which produce pharmaceuticals, biologics for humans and animals, biopharmaceuticals, medical devices, foods, and cosmetics.
A few months back, USFDA shot off a warning letter to the Detroit-based Caraco Laboratories on violation of the Federal Food, Drug and Cosmetic Act.
USFDA claimed that during its inspection at the Caraco plant, it noticed significant deviations from the manufacturing practice guidelines issued by the authorities. This, it claimed, caused the company's drug products to be adulterated.
The USFDA is largely concerned with areas like quality control, record-keeping system and stability-testing programme at Caraco's manufacturing facility.
According to Baheti, the clearances from the USFDA will pave the way for the approval of new drug applications and abbreviated new drug applications (ANDA) submitted by Caraco.
This will also help it in getting permission for its export plans. Caraco has submitted nine ANDAs to USFDA and more than three new chemical entities for approval.
