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Granules India receives USFDA approval for Potassium Chloride ER Capsules


Granules India announced that the US Food & Drug Administration (US FDA) has approved its
Abbreviated New Drug Application (ANDA) for Potassium Chloride Extended-Release Capsules USP, 8 mEq
(600 mg) and 10 mEq (750 mg). It is bioequivalent to the reference listed drug product (RLD), Micro-K
Extended-Release Capsules, 8 mEq and 10 mEq, of Nesher Pharmaceuticals (USA) LLC.
The product would
be manufactured at the company s Hyderabad facility and is expected to be launched shortly.
Potassium Chloride is indicated for the treatment of patients with hypokalemia with or without metabolic
alkalosis, in digitalis intoxications, and in patients with hypokalemic familial periodic paralysis. It is also
indicated for the prevention of hypokalemia in patients who would be at particular risk if hypokalemia ....

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Granules India gets USFDA nod for its Potassium Chloride ER Capsules USP


Granules India gets USFDA nod for its Potassium Chloride ER Capsules USP
February 17, 2021
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Granules India Limited has announced that the US Food & Drug Administration has approved its Abbreviated New Drug Application (ANDA) for Potassium Chloride Extended-Release Capsules USP, 8 mEq (600 mg) and 10 mEq (750 mg).
It is bioequivalent to the reference listed drug product (RLD), Micro-K Extended-Release Capsules, 8 mEq and 10 mEq, of Nesher Pharmaceuticals (USA) LLC. The product would be manufactured at the company’s Hyderabad facility and is expected to be launched shortly.
“We are pleased to announce approval of Potassium Chloride Capsule product within the first review cycle of 10 months from the filing date. This is fourth ANDA approval in our Potassium Chloride product basket,” said Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals, Inc. ....

Andhra Pradesh , Priyanka Chigurupati , Nesher Pharmaceuticals United States , Granules Pharmaceuticals Inc , Granules India , Us Food Drug Administration , Granules India Limited , Drug Administration , Abbreviated New Drug Application , Potassium Chloride Extended Release Capsules , Microk Extended Release Capsules , Nesher Pharmaceuticals , United States , Potassium Chloride Capsule , Potassium Chloride , Executive Director , Granules Pharmaceuticals , Her Capsules , ஆந்திரா பிரதேஷ் , பிரியாங்க சிகுருபடி , ணேஷேற் மருந்துகள் ஒன்றுபட்டது மாநிலங்களில் , துகள்கள் மருந்துகள் இன்க் , துகள்கள் இந்தியா , துகள்கள் இந்தியா வரையறுக்கப்பட்டவை , படாஸீயம் குளோரைடு நீட்டிக்கப்பட்டது வெளியீடு காப்ஸ்யூல்கள் , ணேஷேற் மருந்துகள் ,