USFDA

Co aiming to hit the markets this year to raise over Rs 4,000 crore

Global Pharma Healthcare is recalling 50,000 tubes of eye drops in the US market due to bacterial contamination, according to the US Food and Drug Administration (USFDA). As per its latest Enforcement Report, the US health regulator noted that the Chennai-based drug firm is recalling the affected lot of eye lubricant for artificial tears which have been linked to vision loss in the US. The lot has been manufactured by Chennai-based Global Pharma Healthcare and distributed in the US market by New York-based Delsam Pharma, the USFDA said. Stating the reason for recall, the US health regulator said: "FDA analysis found unopened tubes to be contaminated with bacteria." The company initiated the Class I recall on February 24 this year. As per the USFDA, a Class I recall is the most urgent of the three types of FDA recalls and usually pertains to defective products that can cause serious health problems. In February, Global Pharma Healthcare had announced that it is recalling its entir

Drug firm Lupin on Thursday said the US health regulator has issued a Form-483 with ten observations after inspecting its Pithampur Unit-2 manufacturing facility. The US Food and Drug Administration (USFDA) inspected the plant from March 21 to March 29, 2023. The inspection closed with issuance of a Form-483 with ten observations, Lupin said in a regulatory filing. "We are addressing the observations comprehensively and will work with the US FDA to resolve these issues at the earliest," it added. As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. In November last year, USFDA had issued Form-483 with eight observations each for product and raw material production centres at Lupin's Mandideep-based manufacturing facility. In October 2022, the drugmaker announced that the US health .

Pharmaceuticals firm Lupin Ltd on Monday said it has received tentative approval from the US health regulator to market its generic valbenazine capsules used to treat involuntary movements of the face, tongue or other body parts. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of valbenazine capsules of strengths 40 mg, 60 mg and 80 mg, the company said in a regulatory filing. These are the generic equivalent of Ingrezza capsules, 40 mg, 60 mg, and 80 mg, of Neurocrine Biosciences, Inc, it added. Valbenazine capsules had estimated annual sales of USD 1,235 million in the US, the company said, citing IQVIA MAT December 2022 data.

Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator for its generic doxepin hydrochloride capsules used in the treatment of depression and anxiety. The approval granted by the US Food and Drug Administration (USFDA) is for doxepin hydrochloride capsules of strength 150 mg, the company said in a regulatory filing. The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, it added. Doxepin hydrochloride capsule is indicated to treat mental/mood problems such as depression and anxiety. It helps improve moods and feelings of well-being, relieves anxiety and tension, helps sleep better and increases the energy level, it added. The drug had annual sales of USD 2.11 million in the US, the company said citing IQVIA MAT January 2023 data.

Glenmark Pharmaceuticals on Thursday said it has received an approval from the US health regulator to market a generic medication to treat plaque psoriasis. The company has received final approval from the US Food & Drug Administration (USFDA) for Calcipotriene and Betamethasone Dipropionate Foam, the generic version of Leo Pharma's Enstilar, Glenmark Pharma said in a statement. The USFDA noted that the Mumbai-based drug firm was the first abbreviated new drug application (ANDA) applicant with a paragraph IV certification for Calcipotriene and Betamethasone Dipropionate Foam, it added. "Therefore, with this approval, Glenmark is eligible for 180 days of generic drug exclusivity for Calcipotriene and Betamethasone Dipropionate Foam," the drug firm said. According to IQVIA sales data for the 12-month period ended January 2023, Enstilar Foam (0.005 per cent/0.064 per cent) achieved annual sales of around USD 93.6 million. Shares of the company were trading 0.49 per cent down at Rs ..

Glenmark Pharmaceuticals on Monday said it has received approval from the US health regulator to market a generic product used to treat schizophrenia and in some cases to control severe nausea. The company has received nod from the US Food & Drug Administration (USFDA) for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, the Mumbai-based drug maker said in a statement. The company's product is the generic version of GlaxoSmithKline's Compazine tablets, it added. According to IQVIA sales data for the 12-month period ending January 2023, the Compazine tablets 5 mg and 10 mg achieved annual sales of around USD 26.9 million. Glenmark said its current portfolio consists of 182 products authorised for distribution in the US marketplace and 46 ANDAs (Abbreviated New Drug Applications) pending approval with the USFDA. PTI MSS.

Glenmark Pharmaceuticals on Thursday said its arm has received acceptance from the US health regulator to proceed with a phase 1/2, first-in-human trial for its investigational new drug aimed for treatment of patients with advanced cancers. In a regulatory filing, the company said Glenmark Specialty SA received the acceptance from the US Food and Drug Administration (USFDA) for the investigational new drug (IND) application 'GRC 54276' for the treatment of patients with advanced solid tumours and lymphomas. Developed by Glenmark, GRC 54276 is an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor. HPK1-regulated functions are involved in nearly every step of the cancer-immunity cycle, making it an attractive target for immuno-oncology, the company said. By inhibiting HPK1, GRC 54276 is designed to potentially enhance the patient's own immune system to fight cancers, it added. "Now that the (US)FDA has accepted our IND application, we look forward to

Glenmark Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic antibiotic drug. The company has received final approval from the US Food & Drug Administration (USFDA) for Clindamycin Hydrochloride Capsules, a generic version of Pfizer's Cleocin capsules, Glenmark Pharma said in a statement. Glenmark's Clindamycin Hydrochloride Capsules in strengths of 75 mg, 150 mg, and 300 mg, will be distributed in the US by Glenmark Pharmaceuticals Inc, it added. According to IQVIA sales data for the 12-month period ending January 2023, the Cleocin Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg achieved annual sales of around USD 33.6 million. Glenmark shares were trading 0.12 per cent up at Rs 426.10 apiece on the BSE.

Marksans Pharma Ltd on Friday said it has received final approval from the US health regulator for its generic version of Famotidine tablets indicated for the treatment of acid indigestion and heartburn. The approval granted by the US Food & Drugs Administration (USFDA) for the abbreviated new drug application (ANDA) of Famotidine tablets is for strengths of 10 mg and 20 mg for over-the-counter (OTC) use, Marksans Pharma said in a regulatory filing. The product is bioequivalent to the reference-listed drug (RLD), Pepcid AC tablets, a registered trademark of Johnson & Johnson Consumer Inc which has sales of over USD 200 million in the US market, it added. "We are delighted to continue OTC gastro portfolio expansion for our customers and it will help us to fulfill an important therapy gap created in the Antacids market due to Ranitidine withdrawal," Marksans Pharma Managing Director Mark Saldanha said. The company's OTC Famotidine tablets are acid reducers, used to treat ...

Alembic Pharmaceuticals on Thursday said it has received an approval from the US health regulator to market a generic antidepressant medication in the American market. The company has received an approval from the US Food & Drug Administration to market Brexpiprazole tablets in strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, the drug firm said in a statement. The company's product is therapeutically equivalent to Otsuka Pharmaceutical Co's reference listed drug product Rexulti tablets, it added. Brexpiprazole tablets are indicated as an adjunctive therapy to antidepressants for the treatment of major depressive disorder and for the treatment of schizophrenia. According to IQVIA data, Brexpiprazole tablets in strenghts of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of USD 1.6 billion for 12 months ended December 2022. The US market is the world's largest for pharmaceutical products. In 2021-22 fiscal, India's total pharma exports to global ...

Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator to market a generic breast cancer drug. The company has received approval from the US Food & Drug Administration (USFDA) to market Docetaxel Injection in multiple dose vials, the drug maker said in a statement. The company's approved product is therapeutically equivalent to Hospira Inc's drug. Docetaxel Injections are indicated for breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of head and neck. According to IQVIA data, Docetaxel injection has an estimated market size of USD 11 million in the US market. Shares of the company were trading 0.72 per cent down at Rs 506.40 apiece on the BSE.

Zydus Lifesciences on Tuesday said it has received approval from the US health regulator to market a generic medication to prevent and treat blood clots. The company has received approval from the US Food and Drug Administration (USFDA) to market Apixaban tablets in strengths of 2.5 and 5 mg, according to a regulatory filing. Apixaban blocks the activity of certain clotting substances in the blood. It is used to lower the risk of stroke or a blood clot in people with a heart rhythm disorder called atrial fibrillation. It is also used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery. The drug will be manufactured at the Zydus group's formulation manufacturing facility at Moraiya, Ahmedabad. As per IQVIA MAT December 2022 data, Apixaban tablets had annual sales of USD 18,876 million in the US.

Drug firm Granules India on Monday said it has received approval from the US health regulator to market a generic product to treat high blood pressure. The company has received approval from the US Food & Drug Administration (USFDA) to market Losartan Potassium tablets in strengths of 25 mg, 50 mg, and 100 mg, Granules India said in a regulatory filing. The Hyderabad-based company's product is bioequivalent to the Organon LLC's Cozaar tablets. According to IQVIA/IMS Health, the current annual US market for Losartan potassium tablets is around USD 336 million. Shares of the company were trading 1.24 per cent down at Rs 281.75 apiece on the BSE.

Barring Sun Pharmaceutical Industries, which is anticipated to rally up to 10 per cent; other stocks indicate weak bias, as per technical charts

Shares of Cipla on Monday ended over 6 per cent lower after the company received 'Form 483' with eight observations for its Pithampur-based manufacturing facility. The stock declined 6.02 per cent to settle at Rs 964.05 apiece on the BSE. During the day, it tumbled 6.78 per cent to Rs 956.20. On the NSE, it tanked 6.11 per cent to end at Rs 963 per share. In volume terms, 2.38 lakh shares were traded on the BSE and over 58.29 lakh shares on the NSE during the day. The US Food and Drug Administration (USFDA) conducted a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility from February 6-17, the Mumbai-based drug firm said in a regulatory filing on Saturday. On conclusion of the inspection, the company has received eight inspectional observations in Form 483, it added. The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time, it said. As per USFDA, Form 483 is issued to a firm's managemen

Drug firm Glenmark said it has received approval from the US health regulator to market a generic medication to treat diabetes in the American market. Glenmark Pharmaceuticals Inc, USA, a unit of the company, has received tentative approval from the US Food & Drug Administration (US FDA) for Saxagliptin Tablets in strengths of 2.5 mg and 5 mg, the Mumbai-based drug maker said in a statement. The company's product is the generic version of AstraZeneca AB's Onglyza tablets (2.5 mg and 5 mg), it added. According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza tablets (2.5 mg and 5 mg) achieved annual sales of around USD 122.3 million. Glenmark said its current portfolio consists of 179 products authorised for distribution in the US marketplace. The drug firm has 46 abbreviated new drug applications (ANDAs) pending approval with the USFDA, it added. In addition to these internal filings, Glenmark continues to identify and explore external development ...

The drug major filed an abbreviated new drug application (ANDA) for generic versions of Olaparib tablets - 100 mg and 150 mg with the US Food and Drug Administration (USFDA)

Sun Pharmaceutical Industries on Friday said its subsidiary has received approval from the US health regulator to market a generic medication used in the treatment of multiple myeloma. The company has received final approval from the US Food and Drug Administration (USFDA) for the generic lenalidomide capsules in multiple strengths, Sun Pharma said in a statement. In June 2021, Sun Pharma entered into a settlement with Celgene Corporation (Celgene) to resolve the patent litigation regarding its generic lenalidomide capsules. Under the terms of this settlement, Celgene granted Sun Pharma a license to patents required to manufacture and sell certain limited quantities of generic lenalidomide capsules in the US, beginning sometime after March 2022. In addition, the license allows Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026. Shares of Sun Pharma were trading 0.48 per cent down at Rs 1,002 apiece on the

Drug maker Lupin on Thursday said it has received approval from the US health regulator to market a generic medication, used before a surgery to decrease the volume of secretions from mouth, lungs and stomach, in the American market. The company has received approval from the US Food and Drug Administration (USFDA) for Glycopyrrolate Injection, a generic equivalent of Hikma Pharmaceuticals' Robinul Injection, the Mumbai-based drug maker said in a statement. The product marks the first approval from the company's new injectable facility in Nagpur, it added. "We are committed to building a strong injectable business as part of our growth strategy," Lupin CEO Vinita Gupta said. With the approval of the product from the Nagpur facility, the company can now fast-track its injectable portfolio rollout and build on R&D capabilities in complex products, she added. The approval for Glycopyrrolate clears the path for more internally manufactured injectable products, Gupta stated. As per ..