NEW DELHI: Drug firm Alembic Pharmaceuticals has received approval from the US health regulator for its Telmisartan and Amlodipine tablets used for treatment of hypertension.
The company has received approval from the US Food and Drug Administration (USFDA) for Telmisartan and Amlodipine tablets in the strengths of of 40mg/5 mg, 40mg/10 mg, 80mg/5 mg and 80mg/10 mg, Alembic Pharma said in a BSE filing.
The company’s product is generic version of Boehringer Ingelheim Pharmaceuticals Inc’s Twynsta tablets in the same strengths, it added.
The company now has a total of 50 abbreviated new drug application (ANDA) approvals (44 final approvals and six tentative approvals) from the USFDA, Alembic Pharma said
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube