NEW DELHI: SharonBSE 19.98 % Bio-Medicine today said it has received approval from the US health regulator for its API plant at Taloja in Maharashtra
Facing an increasingly watchful eye of the health regulator in the US, Indian pharmaceutical firms are gearing up to tap new markets in 2016 as they look to consolidate their positions after a spate of mergers and acquisitions consummated this year.
Drug firm Sharon Bio-Medicine today said it has received the establishment inspection report ( EIR) from the USFDA on closure of inspection of its Dehradun manufacturing plant.
Drug firm Sharon Bio-Medicine today said the US health regulator has inspected one of its formulation plants in Dehradun.
India's Sharon Bio-Medicine was issued a warning letter from the U.S. FDA to either pay its generic drug user fees due since 2013 or be barred from shipping products to the U.S., Business Standard newspaper reported.
The owner of the above referenced facility has failed to pay the appropriate facility fee as required by the Generic Drug User Fee Amendments of 2012 (GDUFA). See 21 U.S.C. §§ 379j-41to 379j-42.n nGDUFA defines a facility in relevant part as “a business or other entity . . . at one geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form.” 21 U.S.C. §§ 379j-41(5)(A)(i). If such a facility is identified or intended to be identified in a pending or approved generic drug submission, the person that owns that facility must submit information concerning the facility to FDA (self-identify) each year in accordance with 21 U.S.C. § 379j-42(f). Self-identification for fiscal year 2013 was required on or before December 3, 2012. Self-identification for fiscal year 2014 was required from May 1, 2013, to June 1, 2013. Self-identification for fiscal year 2015 was required from May 1, 2014, to June 1, 2014.n nIf such a facility is identified or intended to be identified in a pending or approved generic drug submission on the facility fee due date, the person that owns that facility must pay an annual facility fee. 21 U.S.C. § 379j-42(a)(4). The fees for fiscal year 2013 were due on March 4, 2013, the fees for fiscal year 2014 were due on October 18, 2013, and the fees for fiscal year 2015 were due on October 1, 2014. Only facilities that manufacture positron emission tomography drugs are exempted from this and other GDUFA fee requirements. See 21 U.S.C. § 379j-42(l). n nAny drugs or active pharmaceutical ingredients (API) manufactured, prepared, propagated, compounded, or processed at a facility for which required facility fees have not been paid or required self-identifying information has not been submitted, or drugs containing an active pharmaceutical ingredient manufactured, prepared, propagated, compounded, or processed at such a facility are misbranded. 21 U.S.C. §§ 352(aa), 379j-42(g)(4)(A)(iii). It is a violation of federal law to ship misbranded products in interstate commerce, which includes causing such products to be imported into the United States. 21 U.S.C. § 331(a). Such violations can result in injunctions or seizures of the misbranded products. See 21 U.S.C. §§ 332 and 334. Products that appear to be misbranded may also be denied entry into the United States. 21 U.S.C. § 381(a)(3).