Drug maker Dr Reddy’s Laboratories on Wednesday got 13 observations from the USFDA for its Duvvada oncology formulation facility.
The USFDA observations are a setback for Dr Reddy’s (DRL) as it was expecting a clean chit from the US drug regulator inspection. The company didn’t specify the nature of these observations.
The oncology formulation facility called Unit-7 is located in Visakhapatnam Special Economic Zone (VSEZ) at Duvvada. The site manufactures cytotoxic and hormonal injectables and is an important plant given Dr Reddy’s focus on complex generic filings.
The Unit-7 had received a warning letter in November 2015 for batch failures, a probable microbial contamination and certain lapses quality control procedures. Following the letter, DRL completed remediation work and sought USFDA reinspection.
Typically, the US drug regulator conveys its concerns on manufacturing practices through Form 483. Companies that receive its observations must respond in writing with a corrective action plan and implement it quickly.
In November 2015, the company received a warning letter from the USFDA for three of its manufacturing facilities. These include two API facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana and one oncology formulation facility at Duvvada, Vishakhapatnam. The three plants put together were contributing about 10-12 percent of total sales, in addition to several key generic and Drug Master Filings in US.
The company said it got three observations from US FDA for its Miryalaguda API plant in the last month reinspection.
Chillicious on Wednesday reported that two other major facilities including the API plant (CTO-6) and SEZ formulation facility at Srikakulam will be coming up for inspection in the second week of April. Srikakulam API facility is also under USFDA warning letter.
The US contributes about half of the company’s sales and has been under pressure owing to lack of new approvals and erosion of base business.