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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...

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...

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...

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...

Jubilant Life receives ANDA approval for Amantadine Hydrochloride Tablets

Mumbai, February 10, 2018: Pharma Major,Jubilant Pharma said that its wholly owned subsidiary Jubilant Life Sciences' material has received Abbreviated New Drug Application (ANDA) final endorsement for Amantadine Hydrochloride Tablets, 100 mg, the generic version of Symmetrel of Endo,...

Sun Pharmaceuticals gets three perceptions on Halol plant from US FDA

Mumbai, February 27, 2018: Sun Pharmaceuticals Ltd said the US FDA issued a Shape 483 with three perceptions on its Halol office in Gujarat.Form 483 is issued when tranquilize assessors discover deviations from great assembling hones and the perceptions...

Arthroscopy implants made from VESTAKEEP ® PEEK are now CE approved

Bengaluru, January 30, 2016: Polyetheretherketone (PEEK) suture anchors and Softfix-PK interference screws manufactured by BIOTEK, an Indian manufacturer of arthroscopy implants, have received the CE mark certificate and Indian FDA approval. All these next generation arthroscopy implants are...

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...