Sun Pharma Gets Six Observations From U.S. FDA For Halol Plant

Sun Pharmaceutical Industries Ltd.’s Halol plant, which was cleared by the U.S. drug regulator earlier this year, received fresh six observations after an inspection conducted from Aug. 27-31.

The observations point to issues related to test procedures, according to the latest Form 483. BloombergQuint has reviewed a copy of the document issued by the U.S. Food and Drug Administration.

The observations, however, don’t bar the plant from filing fresh approvals. The Halol facility will manufacture most of the niche future filings, including injectables, from India’s largest drugmaker.

The unit in June received an ‘establishment inspection report’ from the regulator post an inspection between Feb. 12 and Feb. 23 this year, paving the way for its first drug approval in five years from the plant—Infugem injection used for treating cancer.

The fresh observations are procedural in nature and Sun Pharma will be able to resolve them, Praful Bohra, senior analyst at Equirus Securities, said in a note. “I don’t believe that there will be any holdup of approvals from this plant. The current plant status is clear and they can continue to export and get in new approvals.”

The Mumbai-based drugmaker said it will be submit a response to the U.S drug regulator within 15 business days.

Here is the list of fresh observations:

• Observation 1: Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength quality and purity.
• Observation 2: Procedure designed to prevent micro organisms in drug products not required to be sterile are not followed.
• Observation 3: The written stability programme for drug products does not include sample size based on statistical criteria for each attribute examined to assure valid estimates of stability.
• Observation 4: There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality and purity they purport or are represented to possess.
• Observation 5: Written procedures are not for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Observation 6: The responsibilities and procedures applicable to the quality control unit are not in writing.

Param Desai, vice president at Elara Capital, reiterated that the observations appear to be product-specific and procedural. There are more observations since this is a sterile injectables facility, he said in a note. “Do not see any escalation of these observations based on the current Form 483. Business will continue as usual for the company.”

The stock fell as much as 5.52 percent, after the announcement, its lowest plunge in nearly four months.

(The observations are from the U.S. FDA document and have not been edited)