The company's current portfolio consists of 114 products authorized for distribution in the US marketplace and approximately 64 ANDA’s pending approval with the USFDA.
The regulator had earlier exempted 10 products, including Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen sodium and BOC core succinate, from the import alert.
"The United States Food and Drug Administration (USFDA) inspected Unit 1, manufacturing facility at Bonthapally, Hyderabad of the company from April 3-7, 2017. At the end of the inspection, there were 2 observations given under form 483," Neuland Laboratories said in a BSE filing.
The US Food and Drugs Administration (FDA) (USFDA) is set to begin inspection of Lupin's Aurangabad plant from April 17, reports CNBC-TV18’s Ekta Batra quoting sources.
Drug firm Cadila Healthcare today said the USFDA has completed inspection of its manufacturing plant at Changodar with "no observation".
The approved ANDA is therapeutically equivalent to the reference listed drug product Prozac Tablets, 10 mg and 20 mg, of Eli Lilly and Compan
The company "has received Abbreviated New Drug Application (ANDA) final approval for Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg," Jubilant Life Sciences said in a BSE filing.
The last couple of years have been very unsettling for the sector. It has declined by 25 percent from five-year (2012-16) Compound Annual Growth Rate of 12 percent.
The USFDA had inspected company's manufacturing facilities Plant II and Plant III located in Verna Industrial Estate Area, Goa, between August 31 and September 4, 2016 and issued six observations in Form 483.
According to an EY report, outbound and domestic transactions drove most of the deal activity in 2016, with 21 deals each. In terms of disclosed deal value, the deal size stood at USD 2.1 billion each.
"Glenmark Pharmaceuticals Inc, USA, has been granted tentative approval by the United States Food and Drug Administration (USFDA) for Milnacipran Hydrochloride tablets, 12.5 mg, 25 mg, 50 mg and 100 mg," it said in a BSE filing.
Sun Pharma and Cadila Healthcare are recalling one product each from the US market due to contamination and presence of "foreign" tablets respectively.
"The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture abacavir sulfate and lamivudine tablets, 600 mg/ 300 mg," Aurobindo Pharma said in a BSE filing.
Drug firm Alkem Laboratories today said it has received establishment inspection report (EIR) from the US health regulator on the closure of its inspection at its API facility at Ankaleshwar in Gujarat.
Biocon’s push in a crowded segment is viewed as interesting considering that in the last two years, the company has consciously moved out of products that have seen fierce competition.
The company "has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Meropenem injection 500 mg/vial and 1g/ vial," Aurobindo Pharma said in a filing to BSE.
The company has received United States Food and Drug Administration (USFDA) approval for cancer drug Zejula Capsules, for Tesaro Inc.
An inspection by the US Food and Drug Administration took place at the sterile injectables manufacturing unit between March 9 and 17.
Dr. Reddy’s said it spent about $35-40 million on remediation work that includes legal and professional charges.
The company has received final approval from the US Food and Drug Administration (USFDA) for its Tobramycin Inhalation Solution, the Mumbai-based company said in a statement.
The company that earlier maintained a clean regulatory track record failed spectacularly in the US FDA's audit last December.
"Glenmark Pharmaceuticals Inc, USA has been granted final approval by the USFDA for Clobetasol Propionate Ointment USP, 0.05 per cent," the company said in a BSE filing.
"Aurobindo's Guaifenesin and Dextromethorphan Hydrobromide extended-release tablets are the AB rated generic equivalent of Reckitt Benckiser's Mucinex DM tablets. The product will be launched in Q1 FY18 (in US)," it said.
Drug firm Glenmark Pharmaceuticals USA today said it has got tentative approval from the United States Food and Drug Administration (USFDA) for Fingolimod capsules.
CLSA says Mohali plant clearance is a significant positive development for the company and shows progress on regulatory issues. Clearance makes a large oral solid dosage site available to de-risk existing sites.