In a BSE filing, Lupin announced "the launch of Hydrocodone Bitartrate and Acetaminophen tablets USP, in the strengths of 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg having received an approval from the United States Food and Drug Administration (USFDA) earlier."
Summarising significant deviations from CGMP (current good manufacturing practice) norms at the Vapi unit, the US Food and Drug Administration (USFDA) said that its investigators observed several lapses.
The Duvvada site manufactures cytotoxic and hormonal injectables and is an important plant given Dr Reddy‘s focus on complex generic filings. The Unit-7 received had warning letter in November 2015.
The company "has received abbreviated new drug application (ANDA) approval from the United States Food and Drug Administration (USFDA) for Rizatriptan Benzoate ODT, 5mg & 10mg and Rizatriptan Benzoate Tablets USP, 5mg & 10mg...," Unichem Laboratories said in a filing to BSE.
"The company has received final approval from the US Food and Drug Administration (USFDA) to market tizanidine hydrochloride capsules, USP in strengths of 2mg, 4mg and 6mg," Zydus Cadila said in a regulatory filing today.
The US drug regulator cleared the company‘s investigational new drug application to begin phase two study of GSP 304 that will be used to treat chronic obstructive pulmonary disease.
The US drug regulator USFDA has issued a warning letter to the Mumbai-based pharma company Wockhardt for its Morton Grove facility in the country.
Warning letters resolutions are taking more time than ever before. Only 9 out of 108 warning letters have been sorted taking an average of 500 days. Data for India and China is even bleaker with just one resolution out of the 64 WLs issued in past 52 months, according to Edelweiss report.
"USFDA inspected facility at Aroor village, from February 27 to March 3. There is only one observation," the pharmaceutical company said in its filing.
"The United States Food and Drug Administration (USFDA) inspected our facility at village Aroor from February 27, 2017 to March 3, 2017. There is only one observation," Everest Organics said in a filing to BSE.
The US regulator`s warning letter to the drug maker is nothing new. Over the past four years, regulatory woes have been a recurring theme.
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded and generic formulations, biotechnology products and APIs globally.
Umang Vohra of Cipla reasoned that almost 80 percent of the drugs sold by Cipla in the US market are manufactured in the US itself. He said it will not be a challenge to manufacture all its supplies in the US itself if asked to do so by authorities.
Auto stocks topped the gainers list on both the indices, while Sun Pharma, NTPC and Idea Cellular were a drag. Market breadth points to selling pressure seen on the indices.
Positive domestic and global cues could push up the indices in early trade on Thursday; Wockhardt could be on investors‘ radar following a warning letter issued by US FDA for its Illinois plant
â€œThis would mean that current portfolio of the Company will continue to be made available, however, new approvals will be withheld till resolution,â€ the company said in a statement.
Immigration, healthcare, tax cuts and revamping the military were the four key areas covered. There may have been a nationalist undertone, but there were no details furnished that should rattle financial markets.
In a BSE filing, Lupin said it has "received final approval for its Oxycodone and Acetaminophen Tablets USP, 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg from the United States Food and Drug Administration (FDA) to market a generic version of Vintage Pharmaceuticals LLC's Percocet tablets".
The approved product is indicated for cleansing of the colon in preparation of colonoscopy in adults. Suprep Bowel Prep Kit had US sales of USD 207.2 million.
The company has received approval from the US Food and Drug Administration (USFDA) for Itraconazole capsules, a generic version of Janssen Pharmaceuticals' Sporanox, Jubilant Life Sciences said in a regulatory filing.
"Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA has received the final approval from the United States Food and Drug Administration (USFDA) to market oseltamivir phosphate capsules in strengths of 30 mg, 45 mg, and 75 mg," Cadila Healthcare said in a BSE filing.
India is the key supplier of generic medicines to both US and UK and other parts of Europe. So, it is not surprising that the focus is on India, said Gerald W Heddell, Director-Inspection, Medicines and Healthcare products Regulatory Agency (MHRA).
The US arm of Aurobindo Pharma is recalling 47,040 bottles of Venlafaxine Hydrochloride extended release capsules, manufactured by the Hyderabad-based firm, from the American market.
The company didn‘t explain the nature of these observations. Miryalaguda plant was one among the three plants for which the company got US drug regulator warning letter in November 2015.
Glenmark Pharmaceuticals today said it has received four observations from the US health regulator for its Ankleshwar facility after inspection in December 2016.