U.S. FDA Completes Re-Inspection Of Unit-2 Of Divi’s Laboratories’ Visakhapatnam Facility
This visit by the U.S. FDA was a nine-day re-inspection for review of CAPA.
Divis Laboratories Ltd. said all the previous observations for Unit-2 of its Visakhapatnam facility have been confirmed as “completed and resolved” by the U.S. Food and Drug Regulator (FDA).
The U.S. FDA had issued an import alert in March and a warning letter in May for Unit II. Plants on the FDA's import alert list cannot export drugs to the U.S.
This visit by the U.S. FDA was a nine-day re-inspection for review of Corrective and Preventive Actions (CAPA) that was submitted by the company in response to the deficiencies it received in the last inspection, and also the subsequent commitment the company made post receiving a warning letter from the regulator.
Post the re-inspection, the company has been issued Form 483 with six observations which are procedural in nature, the pharma major said in an exchange filing on Wednesday.
The actual nature and its impact can be understood when the company of makes the observations Form 483 public.
As per the U.S. FDA rules, the company has to respond to these deficiencies within 15 days and post the satisfactory evaluation of the same, the regulator would proceed towards lifting the complete import alert and the warning letter for the company. The entire procedure on an average takes 2-3 months.
The outcome of the re-inspection is a positive development for the Indian pharmaceutical industry reeling under stress of maintaining high compliance requirements, Amit Rajan, managing director of pharma consultancy firm Celogen Lifescience told BloombergQuint.
No observations related to data integrity goes on to prove that the required talent and know-how is available and regulators expectations can be met through extensive training of our own scientific talent pool only, if the company is serious about the same.Amit Rajan, Managing Director, Celogen Lifescience
Divi’s Labs has not informed any likely dates for the inspection of its Unit-1 in Hyderabad, which is also likely to get reviewed by the U.S. FDA as expected when one of the multiple sites of the company serves a warning letter.
This unit also has a considerable chunk of supplies to the regulated market and remains very critical for the company to maintain compliance levels.
The lifting of the import alert and revoking the warning letter would mean that new drug master files (DMFs) from the site would then be accepted for filing by the U.S. FDA, and also the review of old DMF, for which the review would have stopped, would start again.
It remains to be seen how many ANDA (Abbreviated New Drug Application) holders have continued to wait for Divi’s Laboratories to supply the APIs, as it is a general practice in pharmaceuticals, especially in the U.S. business that ANDA holders switch and include an alternate source for supplies.
The nature and extent of this change to alternate suppliers by the ANDA holders can only been seen in the financial results of the company in coming quarters.
Shares of Divi’s Laboratories rose 6.9 percent, the most since December 23 of last year, to Rs 922 as of 1:22 p.m.