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Alembic Pharma gets USFDA nod for Darifenacin Extended Tablets

Mumbai, December 14, 2017: Pharma Major, Alembic Pharmaceuticals said that it company received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Darifenacin extended release tablets, 7. 5mg and 15mg. Darifenacin extended release...

Lupin receives FDA approval for generic Tamiflu Capsules  

Mumbai, January 11, 2018: Pharma Major Lupin announced that it has received final approval for its Oseltamivir Phosphate Capsules USP,30 mg (base), 45 mg (base), and 75 mg (base) from the United States. UNI

Biocon, Mylan’s Biosimilar Trastuzumab gets ANVISA’s approval

Mumbai, Janaury 04, 2018: Biotechnology mAJOR, Biocon and Mylan have received approval for Biosimilar Trastuzumab from ANVISA, the Brazilian regulatory agency, through their partner Libbs Farmaceutica (Libbs), a leading Brazilian pharmaceutical company. Co-developed by Biocon and Mylan, this is the first...

JB Chemicals receives USFDA nod for Atenolol tablets

Mumbai, December 14, 2017:Pharma firm, JB Chemicals & Pharmaceuticals has received USFDA approval for its Supplementary Abbreviated New Drug Application (sANDA) for Atenolol Tablets USP 25 mg. 50 mg.and 100 mg. (anti-hypertensive) manufactured using company's own bulk drug (API). The company had initiated this change as...

TUV Rheinland extends A2LA Accreditation and FCC Approvals in Asia-Pacific’s most important markets

Addition of labs in Guangzhou and Shanghai in China, along with Bangalore in India will help customers meet the wireless, EMI and EMC testing and certification requirements for products aimed at the North American market Bengaluru, January 14, 2018: TUV Rheinland...

Genzyme’s Lemtrada Approved by the FDA

New Delhi, November 18, 2014 - Genzyme, a Sanofi company, announced that the U.S. Food and Drug Administration (FDA) has approved LemtradaTM (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS). “The approval is the...

Nectar Lifesciences Limited (NecLife) receives ANVISA approval for its Cephalosporin API’s manufacturing facility

New Delhi, June 01, 2015 Nectar Lifesciences Limited (NecLife) has received ANVISA cGMP (“Current Good Manufacturing Practices”) approval for its Cephalosporin API’s manufacturing facility. The National Health Surveillance Agency (in Portuguese, Agência Nacional de Vigilância Sanitária, ANVISA) is a regulatory...

Ranbaxy gets approval to launch anti-malarial drug in 7 African countries

Company is confident that Synriam will help the govt and healthcare system in Africa to fight the menace of malaria New Delhi, Dec 24, 2014 - Drug firm Ranbaxy Laboratories has received regulatory nod to launch its indigenously developed anti-malarial...

TGA Australia APPROVAL OPENS UP AUSTRALIAN MARKETS FOR AMANTA HEALTHCARE

Ahmedabad, May 06, 2016: Amanta Healthcare, India’s leading manufacturer and marketer of sterile dosages and Blow-Fill-Seal (BFS) specialist, opens a new chapter in Australia with the award of the Therapeutic Goods Administration (TGA) approval for Sterile Water For Injections...

Government approves FDI worth Rs 4,000 crore by four pharma firms

New Delhi, June 18, 2015: Proposals for foreign direct investment amounting to around Rs 4,000 crore by four pharma and medical devices firms, including Torrent Pharmaceuticals BSE 1.82 % and Biocon's research services arm Syngene, were today approved by...