Working on oral generics? Join FDA & CRCG on May 5-6 for expert-led sessions on innovative and alternative BE strategies, model integrated evidence & more! Virtual & in-person options. Register now: complexgenerics.org/educatio…
#OralGenerics #ComplexGenerics #FDA #RegulatoryScience
ALT A promotional image for the FDA/CRCG Workshop on Bioequivalence Innovations for Generic Oral Products. It will be held on May 5-6, 2026, with hybrid attendance options via Zoom and in-person. The location is The Universities at Shady Grove, Building II, Rockville, MD. Time schedules for Day 1 and Day 2 are listed. The FDA logo is visible.
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Feb 24
Indian pharma companies have increased exposure to complex generics 💊
These high-value, difficult-to-manufacture drugs face lower competition.
#ComplexGenerics #USBusiness #CompetitiveEdge
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Jan 8
We are pleased to share that Granules Pharmaceuticals, Inc., our wholly-owned subsidiary, has received Tentative Approval from the USFDA for its ANDA for generic Amphetamine Extended-Release Tablets (5 mg, 10 mg, 15 mg, 20 mg), the generic equivalent of DYANAVEL XR®.
The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and we are eligible for 180-day exclusivity, reinforcing our commitment to strengthening our presence in the CNS therapeutic space and driving value creation in the U.S. generics market.
#USFDA #Generics #ADHD #Innovation #GranulesIndia #ComplexGenerics
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22 Dec 2025
A step forward in advancing our generics portfolio and patient-centric solutions.
Granules Pharmaceuticals, Inc., our US subsidiary, has received Tentative Approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets in multiple strengths 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg. It is the generic equivalent of ADZENYS XR-ODT®.
For more details, click here:
shorturl.at/4uuR7
#GranulesIndia #US #Generics #USFDA #ANDA #ComplexGenerics #CNS #ADHD #PharmaceuticalsManufacturing
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27 Nov 2025
India has long been the backbone of global generics, but the landscape is changing rapidly. With complex generics, peptides and next-gen therapies gaining global relevance, India’s strength will increasingly lie in how well we transition from high-volume manufacturing to high-value innovation.
This shift is not just an opportunity, it’s essential for staying relevant in the next decade of global healthcare.
#PharmaInnovation #IndianPharma #ComplexGenerics #NextGenTherapies
newindianexpress.com/nation/…
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30 Sep 2025
Explore strategies for bioequivalence, formulation sameness, and quality standards for generic ophthalmic products. #ComplexGenerics #OphthalmicGenerics #RegulatoryScience
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18 Apr 2024
Join us on our upcoming #webinar on #Biomarkers and Endpoints Assessments in #COPD #ComplexGenerics Trials to discover the primary and secondary endpoints that drive COPD trials forward and more.
Register now: forms.gle/1Gh6xkwTVJAJFKiRA
#Veeda #VeedaGroup #ClinicalTrials
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6 Sep 2023
Don't miss this opportunity to connect with our experts. Join us at #BiopharmAmerica 2023, from September 13–14, 2023, in the Vibrant Research Triangle Park, NC.
Book a meeting - bit.ly/3BK1KVW
#Veeda #Biopharm #ClinicalTrials #Bioanalytical #ComplexGenerics #Generics
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22 Jun 2023
Lupin gets USFDA approval for its ANDA for Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, a generic equivalent of Spiriva HandiHaler
1st Generic approval of Spiriva HandiHaler
IQVIA - US Sales (MAT 2023): $1.24Bn
Key Respiratory Drung Product
#Lupin #ComplexGenerics
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28 Apr 2023
We are excited to share a glimpse of our team who attended #CPHINorthAmerica 2023.
Our team had a great opportunity to discuss the #drugdevelopment needs of Generics, #ComplexGenerics, and #Innovatordrug molecules with various global pharma and biopharma companies.
#Veeda
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21 Apr 2023
Do not forget to interact with our experts at #CPHI North America 2023 and learn how @Veeda can add value to your #drugdevelopment journey for your Generics, #ComplexGenerics, #Biosimilars and Innovator drug candidates.
Book a meeting – bit.ly/3BK1KVW
#CPHINorthAmerica
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17 Apr 2023
A Trailblazer in India's Pharmaceutical Industry.
Read our latest blog on it at: bit.ly/41ciiRT
#CooperPharma #innovation #Sustainability #healthcare #PharmaIndustry #AffordableMedicines #MedicineManufacturing #ResearchAndDevelopment #Biosimilars #ComplexGenerics #blog
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12 Apr 2023
Attendees may ask questions in real time to a panel of FDA, @complexgenerics, and industry experts and attend a discussion on ways to reduce the time to potential generic drug product approval.
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12 Apr 2023
ICYMI: Join FDA and @complexgenerics for the “Considerations for and Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Generic Orally Inhaled Drug Products” workshop on April 20-21, 2023. complexgenerics.org/OIDP-CCE…
ALT Text reads " Considerations for and Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Generic Orally Inhaled Drug Products April 20-21, 2023 8:30AM – 5:30PM." Graphic on blue background with assortment of inhalers and a sleeve of capsules with FDA logo and Complex Generics logo in the lower right corner.
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27 Jan 2023
Attendees may ask questions in real time to a panel of FDA, @complexgenerics, and industry experts and attend a discussion on ways to reduce the time to potential generic drug product approval.
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27 Jan 2023
Join FDA and @complexgenerics for the Considerations for and Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Generic Orally Inhaled Drug Products workshop on April 20-21, 2023 complexgenerics.org/OIDP-CCE…
ALT Text reads " Considerations for and Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Generic Orally Inhaled Drug Products April 20-21, 2023 8:30AM – 5:30PM." Graphic on blue background with assortment of inhalers and a sleeve of capsules with FDA logo and Complex Generics logo in the lower right corner.
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Join the @US_FDA and @complexgenerics for a free public workshop on October 27-28, 2022 from 8:30 a.m. - 5:00 p.m.: Best Practices for Utilizing Modeling Approaches to Support Generic Product Development.
Register now! complexgenerics.org/generic-…
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25 Oct 2022
Same to you! I've been called an "honorary Indian" by @NehalMehtaMD, so now I am celebrating this holiday! I can always sign up for "knowledge and good over ignorance and evil" (from Wikipedia) 😀.
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24 Oct 2022
Happy Diwali Anna! Hope this Diwali brings to you lot of light, happiness and the goddess of money Laxmi brings lot of funding :).
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24 Oct 2022
Leading @complexgenerics I have learned to appreciate Indian culture and sense of humor 😀! To all friends, students and collaborators @VishaKrishn @kannan_RM_JHU @NagrathSunitha @a_annapragada @DNagrathLab @sahayg1 @SMitragotri @US_FDA @aaps_umich @UMichPharmacy Happy Diwali!
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