ANDA
Dr Reddy's bets on generic semaglutide, biosimilars
Dr Reddy's domestic formulations business grew in the September quarter, while Revlimid sales declined in North America. A relaunch of generic semaglutide and the US launch of abatacept biosimilar are anticipated for future growth. The company aims to sell millions of pens for semaglutide with a focus on international markets. Furthermore, an expanding biosimilars portfolio aims to strengthen its position beyond traditional generics.
‘Yahan bidi toh milegi’: Sanjay Dutt recalls staying strong in jail, reveals what happened after official denied him cigarettes
Sanjay Dutt recently discussed his experiences during his imprisonment on Shekhar Suman's talk show. He shared how he managed to remain strong through many personal challenges and legal battles. Dutt recalled the emotional moment when he was handcuffed in front of his father, actor Sunil Dutt. He emphasized that his stardom did not create a sense of superiority while in jail.
Spanish Proverb of the Day: 'Poco a poco se anda lejos' – 'Little by little, one goes far' - A timeless lesson on progress
Spanish Proverb of the Day: The Spanish saying 'Poco a poco se anda lejos' conveys the importance of taking small, steady steps toward long-term goals. This proverb reminds us that patience and consistent effort lead to substantial achievements, contrasting the contemporary obsession with rapid success. Its message remains pertinent for both personal growth and career advancement, encouraging individuals to value the journey over immediate results.
Lupin gets USFDA approval for Modafinil tablets to treat excessive sleepiness
Pharmaceutical major Lupin announced its USFDA approval for Modafinil tablets. These tablets are used to treat excessive sleepiness in adult patients. The approved drug is bioequivalent to Provigil Tablets of Nuvo Pharmaceuticals. Modafinil tablets had estimated annual sales of USD 70.7 million in the United States. Lupin currently operates 15 manufacturing facilities globally.
Aurobindo Pharma launches generic Advair Diskus for asthma and COPD in US
Lannett Company, part of Aurobindo Pharma, has launched generic Advair Diskus in the US, making it the first complex inhalation product from Aurobindo to be marketed there. This market is worth approximately $908 million. Moreover, Cipla's US branch has also obtained FDA approval for the same product, setting the stage for an exciting competition in respiratory treatments.
Zydus Lifesciences gets USFDA nod for generic ascorbic acid injection
Zydus Lifesciences secured final USFDA approval for its generic ascorbic acid injection. This approval is for the treatment of scurvy in specific patient groups. The company's product is the generic equivalent of the Ascor injection. The USFDA designated this application as a Competitive Generic Therapy. Zydus will market the product in the United States market.
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Senores Pharma to acquire 14 ANDAs from Dr Reddy's Laboratories
Senores Pharmaceuticals of Gujarat has signed an agreement to acquire 14 Abbreviated New Drug Applications from Dr Reddy's Laboratories. The acquisition, funded through IPO proceeds, includes 13 USFDA-approved ANDAs. This expands Senores' product offerings in the US and other regulated markets, addressing an opportunity worth USD 421 million.
Glenmark Pharmaceuticals acquires certain OTC drugs from Wockhardt in US
"The over-the-counter market has long been an important segment of Glenmark's portfolio around the world. Our acquisition of these ANDAs represents the continued expansion of our business into the OTC market here in the United States and our commitment to ensuring patients have access to high quality, affordable medicines," Glenmark Pharmaceuticals Inc, USA, President Sanjeev Krishan said.
Alembic Pharma gets tentative USFDA nod for generic version of Dabigatran Etexilate capsules
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug (RLD) product Pradaxa Capsules, 75 mg, 110 mg, and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc (Boehringer)
Anda the spell of an Insta egg
Which is the most ‘liked’ image on Instagram? The world’s most popular leader? No. Leo Messi? Nope.
Alembic Pharma's JV Aleor Dermaceuticals gets American regulator nod for Testosterone Gel
Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its ANDA for its abbreviated new drug application (ANDA) for Testosterone Gel, 1.62%, Alembic Pharmaceuticals said in a regulatory filing.
Alembic Pharma gets tentative USFDA nod for breast cancer treatment drug
"The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) in the strengths of Palbociclib capsules, 75 mg, 100 mg, and 125 mg," Alembic Pharmaceuticals said in a regulatory filing.
Alembic Pharma JV gets USFDA nod for antifungal topical solution
Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Tavaborole Topical Solution, 5 per cent, Alembic Pharmaceuticals said in a BSE filing.
US generics business to continue its growth momentum: Pharma firm Cadila Healthcare
According to the Cadila Healthcare's annual report for fiscal year 2019-20, the company is planning to introduce additional "topical, transdermal and injectable products" in coming years. The US was the largest contributor to the consolidated revenues of the company with 45 per cent share, it said.
Alembic gets USFDA nod for Vilazodone Hydrochloride tablets used to treat depression
"The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Viibryd tablets, 10 mg, 20 mg, and 40 mg, of Allergan Sales," the drug firm said. Citing IQVIA, the company said Hydrochloride tablets, 10 mg, 20 mg, and 40 mg, have an estimated market size of USD 469 million for 12 months ending September 2019.
USFDA hikes fee for processing ANDA by $1 lakh for FY18
According to a notification on USFDA's website, fee for Drug Master File was reduced to USD 47,829 for 2017-18 from USD 51,140 in the last fiscal.
Panacea Biotec, US's Bionpharma join hands for 7 drugs
Under the collaboration, Panacea will be responsible for development, filing, registration, manufacturing and supply of these ANDAs, the company said.
Alembic Pharma's partner launches drug for depressive disorder
Alembic Pharma had received approval of its ANDA of desvenlafaxine succinate extended release tablets of strengths 50 mg and 100 mg in June 2015.
Sun Pharma announces voluntary withdrawal of 28 ANDAs
The company, in a regulatory filing to stock exchanges, said the withdrawn drugs were the older products from the erstwhile Ranbaxy laboratories, and are not being marketed in US since 2008.
Zydus Healthcare buys 2 ANDAs from Teva
The company said these ANDAs have been acquired by its 100 per cent subsidiary, Zydus Worldwide DMCC and will be financed through the group's internal accruals.
Dr. Reddy’s buys eight ANDAs from Teva for $350 million
Dr. Reddy’s said the acquisition of ANDAs is contingent on closing of the Teva generics transaction and approval by the US Federal Trade Commission.
Aurobindo Pharma gets USFDA nod for oral contraceptive tablets
The product has an estimated market size of $64 million for the twelve months ending October 2015 according to IMS, Aurobindo Pharma said.
Two clients of Dr Reddy's saw revocation of ANDAs
The company said the ANDAs of the customers were approved in January and February 2015, post US FDA’s inspection of the company's API facilities.
Claris Lifesciences surges on ANDA approval
Stocks of Claris Lifesciences climbed over 4% after one of its existing shareholders sold out its entire stake in the company via a block deal.
Natco Pharma's partner Mylan Inc files ANDA for generic Copaxone
According to IMS health, Copaxone 40 mg/mL had US sales of nearly USD 411.5 million for the 12 months ending June 30, 2014, it added.
Sun Pharmaceuticals files ANDAs for 4 products in Q1 FY14
Sun Pharmaceutical Industries filed Abbreviated New Drug Applications for 4 products & received 9 approvals from USFDA in Q1 this fiscal.
Indian pharmaceutical companies bag 40 per cent of ANDAs approved by USFDA: Report
Indian pharma companies bagged around 40% of all Abbreviated New Drug Approvals (ANDA) approvals from USFDA between January and July 2013.
Funda ya Anda?
Funda stands for something cool and awesome. Ditto for gyan: This word has one the most impressive of pedigrees in the Indian philosophical tradition.
Hasan Ali lodged in high security "anda cell"
Hasan Ali, arrested on charges of stashing away billions of dollars in foreign banks and tax evasion, has been lodged in the high security "anda cell".
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