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    Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

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    About

    Vamsi Labs, established in 1991, is a leading Indian API manufacturer. Specializing in anti-asthmatic, anti-migraine & anti-psychotic APIs, it caters to domestic & international markets(50% sales). Anti-asthma products account for 60% of sales. Vamsi adheres to high corporate governance, transparency, professionalism, & environmental protection standards. It's USFDA & EDQM certified & ISO 9001:2015, ISO 14001:2015, & ISO 45001:2018 certified. With a DSIR-certified R&D Lab, Vamsi continues to innovate & meet the pharma industry's evolving needs. Vamsi is poised to grow its globally while maintaining commitment to excellence and sustainability.

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    A-14, A-15, A-31, A-32 & A-33, MIDC Area, Chincholi, Solapur - 413255, Maharas...
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    +91 2172357274
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    marketing@vamsilabs.com
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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2023

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    Corporate Presentation

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    GMP Certificate 2024

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    API Product List 2023

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    Intermediates Product List 2023

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    APIs Under Development 2023

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    USFDA EIR Letter

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    GMP Certificate 2022-2023

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    WHO GMP 2021-2024

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    DATA COMPILATION #PharmaFlow

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    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    USDMF

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    01

    Fluticasone Furoate Ep

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    Virtual BoothVamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

    Vamsi Labs

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40418

    Submission : 2024-08-26

    Status : Active

    Type : II

    Vamsi Labs

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    02

    Fluticasone Propionate Ep

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40285

    Submission : 2024-08-13

    Status : Active

    Type : II

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    03

    Haloperidol Usp

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    Vamsi Labs

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34283

    Submission : 2019-11-14

    Status : Active

    Type : II

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    04

    Ipratropium Bromide-ep

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    Vamsi Labs

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40419

    Submission : 2024-08-28

    Status : Active

    Type : II

    Vamsi Labs

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    05

    Tiotropium Bromide Monohydrate

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2021-01-11

    Pay. Date : 2020-11-04

    DMF Number : 34808

    Submission : 2020-04-15

    Status : Active

    Type : II

    Vamsi Labs

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    06

    Clenbuterol Hydrochloride Ep

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40283

    Submission : 2024-08-06

    Status : Active

    Type : II

    Vamsi Labs

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    07

    Cyproheptadine Hydrochloride- Ep

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    Virtual BoothVamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40578

    Submission : 2024-09-30

    Status : Active

    Type : II

    Vamsi Labs

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    08

    Fenoterol Hydrobromide-ep

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40580

    Submission : 2024-09-26

    Status : Active

    Type : II

    Vamsi Labs

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    09

    Formoterol Fumarate Dihydrate Ep

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40450

    Submission : 2024-08-31

    Status : Active

    Type : II

    Vamsi Labs

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    10

    Salbutamol Sulfate- Ep

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40579

    Submission : 2024-09-30

    Status : Active

    Type : II

    Vamsi Labs

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    CEP/COS

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    Clenbuterol Hydrochloride

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    Vamsi Labs

    Certificate Numbers : R0-CEP 2020-172 - Rev 01

    Status : Valid

    Issue Date : 2022-07-28

    Type : Chemical

    Substance Number : 1409

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    02

    Fenoterol hydrobromide

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    Vamsi Labs

    Certificate Numbers : CEP 2020-160 - Rev 02

    Status : Valid

    Issue Date : 2023-11-14

    Type : Chemical

    Substance Number : 901

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    03

    Fluticasone propionate, Micronised

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    Certificate Numbers : CEP 2020-078 - Rev 02

    Status : Valid

    Issue Date : 2023-12-11

    Type : Chemical

    Substance Number : 1750

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    04

    Formoterol fumarate dihydrate

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    Vamsi Labs

    Certificate Numbers : R1-CEP 2006-227 - Rev 02

    Status : Valid

    Issue Date : 2022-07-28

    Type : Chemical

    Substance Number : 1724

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    05

    Haloperidol

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    Certificate Numbers : R0-CEP 2020-149 - Rev 00

    Status : Valid

    Issue Date : 2023-04-04

    Type : Chemical

    Substance Number : 616

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    06

    Ipratropium bromide, Micronised

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    Certificate Numbers : CEP 2023-137 - Rev 00

    Status : Valid

    Issue Date : 2024-11-05

    Type : Chemical

    Substance Number : 919

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    07

    Salmeterol xinafoate, Non-micronised and...

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    Vamsi Labs

    Certificate Numbers : CEP 2006-226 - Rev 03

    Status : Valid

    Issue Date : 2024-03-05

    Type : Chemical

    Substance Number : 1765

    Vamsi Labs

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    08

    Tiotropium bromide monohydrate, Micronis...

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    Certificate Numbers : CEP 2012-285 - Rev 02

    Status : Valid

    Issue Date : 2024-01-16

    Type : Chemical

    Substance Number : 2420

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    KEY PRODUCTS

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    Inspections and registrations

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    FDA

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    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-03-16

    Vamsi Labs

    City : Solapur North

    State :

    Country/Area : India

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    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-03-16

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    GMP Certified

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    Type : GMP Certificates

    Number : ES/079/24

    EudraGMDP Key : 170787

    Country : India

    Issue Date : 2024-06-27

    Post Code : 413255

    NCA Ref : 12342-001

    City : Solapur

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    ABOUT THIS PAGE

    Contact Vamsi Labs and get a quotation

    Vamsi Labs is a supplier offers 44 products (APIs, Excipients or Intermediates).

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