Sun Pharmaceutical Industries (SPI ), a US-based wholly owned subsidiary of India’s most valued drugmaker Sun Pharmaceutical has received a warning letter from the US Food & Drug Administration (USFDA).

The letter follows a chain of recent actions initiated by the US drug regulator against Indian companies such as Ranbaxy, Lupin, Glenmark and Sun Pharma’s Caraco unit. But independent analysts covering the Indian pharma sector don’t see any reason for concern.

The FDA letter was issued as a follow-up to the last inspection of SPI Inc’s manufacturing facility in Cranbury, New Jersey, initiated in February 2010 when it’s violations of current Good Manufacturing Practice (cGMP) regulations were first identified.

“SPI has undertaken immediate corrective actions. The firm intends to respond promptly and timely to USFDA within 15 working days,” Sun Pharma said in a statement.

USFDA may, in the near term, withhold approval of pending new drug applications listing the facility as the manufacturer. However, Sun Pharma has still maintained its 2010-11 consolidated sales growth guidance.

"FDA is increasingly becoming stricter. There is no problem with Indian companies. If you look at FDA's record, companies which have interests in the US pharma market are being regularly held up for any violations in manufacturing practices," said Ranjit Kapadia, vice-president (institutional research), HDFC Securities.

Large Indian generic companies like Ranbaxy (Paonta Sahib & Dewas facilities), Lupin (Mandideep facility), Caraco (Detroit facility), Glenmark (on a specific drug) have received FDA letters in the recent past.

"But for every instance that has appeared, there are hundreds of plants in India that are working fine. There is no pattern if you are suggesting a nationwide problem in pharma manufacturing. It’s just that we hear about these more now," said Chirag Dagli, vice-president (research), Pioneer Investcorp (PINC), who covers pharmaceuticals.

"It’s a time-consuming process. But as we have seen in the case of Lupin, it has been resolved. The same will happen with others. Ranbaxy's issues have taken some time to resolve. We don't see any drop in investor interest in Indian pharma stocks due to these warning letters," said Sarabjit Kaur Nangra, vice-president (research), Angel Broking.

Giving an update on its Caraco plant, a Sun Pharma official told Financial Chronicle that Caraco is working with a FDA-mandated consultant to gets it site back into approval.