* Receives FDA warning letter related to environmentalmonitoring
* Says Portugal plant was inspected in March
* Sees no impact on manufacturing, distribution from plant
* Says warning not to impact full-year financial guidance
* Stock slips 6 pct; top loser on FTSE-250 Midcap Index (Adds additional analyst comments; updates share movement)
Oct 24 (Reuters) - Drugmaker Hikma Pharmaceuticals Plc said the U.S. health regulator had raised issues relatedto environmental monitoring at its plant in Portugal, which someanalysts said accounts for about a quarter of the company's U.S.injectibles sales.
Shares in the Jordanian company fell more than 6 percent onFriday as the warning added to disappointment of weak brandeddrug sales and a case filed by Takeda Pharmaceutical Co against the approval of Hikma's drug for gout flares.
Hikma's stock was the top percentage loser on the FTSE-250Midcap Index in the morning.
Hikma, which makes and markets branded and non-brandedgenerics and injectibles, said it received a warning letter fromthe U.S. Food and Drug Administration on Thursday following aninspection of the plant in March.
The drugmaker did not specify what the issues were but saidit did not anticipate any impact on its full-year financialforecast or the manufacturing or distribution of products fromthe plant.
Hikma makes powder, liquid and lyophilised injectible drugsat the Portugal plant, which started in 1997.
However, Citi Research analysts said Hikma had a dedicatedR&D line in Portugal and the warning letter would impactapproval of new products from that facility.
"We estimate Portugal remediation will likely be lessdisruptive and expensive vs Eatontown, but acknowledge thatresolving warning letters typically tends to be a long drawn outprocess."
Hikma had to suspended manufacturing at its Eatontownfacility in New Jersey for over a year after it received an FDAwarning letter in February 2012.
The plant underwent extensive remediation work beforegetting the go-ahead to restart in April.
Hikma has 27 plants in 11 countries.
Most analysts, however, said that since the warning letterwas issued seven months after the inspection, it is unlikelythat it was too severe and would require shutting the plant.
Hikma, which grew at a rapid pace last year on the back of ashortage for the antibiotic doxycycline, has seen strong demandfor its high-margin injectibles, particularly in the UnitedStates.
Hikma strengthened the business earlier this year byacquiring Boehringer Ingelheim's U.S. generic injectiblesbusiness and manufacturing operations in Ohio.
The injectibles business accounted for $536 million, or 39percent of the company's revenue in 2013, with U.S. injectiblessales bringing in 68 percent of that. The company said earlierthis year it expected the business to grow 20 percent in 2014.
Hikma shares were down 5.7 percent at 1791 pence at 1015GMT. The stock has risen 18 percent over the past 4 weeks onspeculation that the company is in talks to buy privately heldU.S. rival CorePharma. (Reporting by Roshni Menon in Bangalore; Editing by GopakumarWarrier and Don Sebastian)
Hikma Pharmaceuticals (HIK)
