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Marksans Pharma Ltd on Friday said it has received final approval from the US health regulator for its generic version of Loratadine tablets indicated in the treatment of allergic rhinitis. The approval by the US Food and Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) for Loratadine tablets of strength 10 mg, Marksans Pharma said in a regulatory filing. Loratadine tablets are indicated for the treatment of allergic rhinitis caused by pollen and upper respiratory tract allergy for over-the-counter (OTC) use. This product is a generic version of Clartin tablet in the same strength as Bayer Healthcare, the company added. Loratadine is an antihistamine that treats symptoms such as itching, runny nose, watery eyes, and sneezing from "hay fever" and other allergies, it added.
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 ...
Drug firm Marksans Pharma on Tuesday said it has inked a pact with Tevapharm India to acquire its Goa-based bulk pharmaceutical formulations business. The company has entered into a business transfer agreement with Tevapharm to acquire its business relating to the manufacture and supply of bulk pharmaceutical formulations as a going concern on a slump sale basis. The drug firm has agreed to retain the site employees with existing terms of employment, Marksans Pharma said in a regulatory filing. The transaction is in cash consideration and expected to be finalised by April 1, 2023, subject to the closing conditions, it said, but did not specify the deal value. Teva's affiliate Watson Pharma will continue to own and operate Tevapharm's other manufacturing site at Verna, Goa, the drug firm added. Marksans will continue to supply Teva's affiliates with certain products until the end of FY23 as part of the agreement, which can be extended further with mutual agreement, it said. "The .