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ANDA FILING
Alembic Pharma gets tentative nod from USFDA for generic cancer drugAlembic Pharmaceuticals has secured tentative approval from the USFDA for its generic Binimetinib tablets. This marks a significant step fo...- Concord Biotech shares gain 6% after USFDA approval for Tofacitinib tabletsConcord Biotech's shares surged over 6% after receiving USFDA approval for its Tofacitinib Tablets in 5 mg and 10 mg strengths. This approv...
- Concord Biotech shares jump 8% on USFDA nod for Mycophenolate Mofetil oral suspensionConcord Biotech shares saw a significant jump on Wednesday. This surge followed the company's announcement of receiving approval from the U...
- Alembic gets USFDA nod for generic levothyroxine sodium tabletsAlembic Pharmaceuticals has secured final approval from the US health regulator for its generic levothyroxine sodium tablets. This medicati...
- Cipla gets USFDA nod for generic respiratory issues treatment inhalation aerosolPharma major Cipla has secured final approval from the US health regulator for its generic albuterol sulfate inhalation aerosol. This marks...
- Marksans Pharma gets USFDA nod for generic Benzonatate capsulesMarksans Pharma has received final approval from the US Food and Drug Administration for its generic version of Benzonatate capsules used t...
- US generics business to continue its growth momentum: Pharma firm Cadila HealthcareAccording to the Cadila Healthcare's annual report for fiscal year 2019-20, the company is planning to introduce additional "topical, trans...
- Natco Pharma gets USFDA approval for Visakhapatnam facilityHyderabad-based Natco Pharma Ltd on Tuesday said it has received the final approval from the US health regulator for its first supplemental...
- 2020 to prove disappointing for Indian pharma: Amit RajanSun Pharma, Lupin and others are falling apart on injectable inspections and this is where the problem starts.
- Strides Shasun rallies 2% on USFDA drug approvalThe company has 74 cumulative ANDA filings with the USFDA.
- Alembic Pharma's partner launches drug for depressive disorderAlembic Pharma had received approval of its ANDA of desvenlafaxine succinate extended release tablets of strengths 50 mg and 100 mg in June...
- Gagillapur unit contributes over 50 per cent to revenues: C Krishna Prasad of Granules IndiaThe main growth, the boost for growth of Granules India from now on would be in complex molecules and extended release, controlled release ...
- There're lots of challenges due to triple impact in the pharma sector: Sanjay Jain, CFO, FDCIn an interview with ET NOW, Sanjay Jain, CFO, FDC talks about the reasons behind company's revenue surge, growth plans and the challenges ...
- Prefer Torrent Pharma in midcap pharma space; see stock at Rs 1,677: Daljeet Singh KohliTorrent Pharma Q1 numbers were ahead of expectations, although some people have raised questions over what is next, says Kohli.
- Jubilant Life gets USFDA nod for generic anti-asthma tablets"This includes 72 ANDAs filed in the US, of which 35 have been approved and 46 dossier filings in Europe. So far, we have received 10 ANDA ...
- Natco Pharma's partner Mylan Inc files ANDA for generic CopaxoneAccording 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 FY14Sun Pharmaceutical Industries filed Abbreviated New Drug Applications for 4 products & received 9 approvals from USFDA in Q1 this fiscal.
- Glenmark gets first nod for Zetia genericGlenmark Pharmaceuticals has got tentative approval from the USFDA for the generic version of Schering Plough and MSP Singapore Company LLC...
- Dr Reddy’s Laboratories finetunes US generics planThe company, which has plans to file at least 20 Abbreviated New Drug Applications every year with the US FDA, plans to selectively file su...
- Glenmark's US arm in $27m-deal with Paul CapitalThe US subsidiary of Glenmark Pharmaceuticals (Glenmark) has signed a $27m deal with Paul Capital Partners’ Royalty Fund.
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