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    Swati Spentose Pvt. Ltd. (SSPL), part of the 60-year-old V Group, is a globally trusted pharmaceutical manufacturer supplying to 70+ countries. We specialize in high-quality APIs and are forward-integrated into Finished Dosage Forms, offering end-to-end solutions. SSPL Unit 1 is USFDA inspected, EU-GMP, ANVISA, WHO-GMP, COFEPRIS, MFDS certified, AFM: AG12300239. SSPL Unit 2 is PMDA inspected and WHO-GMP, ANVISA certified. We look forward to exploring collaboration opportunities. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

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    India
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    114 Marine Chambers, 11 New Marinelines, Mumbai 400020, Maharashtra
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    +91 2261505200
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    info@swatispentose.com
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    https://spentose.com/
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    Product List 2025

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    Corporate Presentation

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    GMP Certificate 2023

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    DATA COMPILATION #PharmaFlow

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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    01

    Lidocaine

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Virtual BoothSWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-10-06

    Pay. Date : 2013-09-23

    DMF Number : 25830

    Submission : 2012-02-22

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2013-138 - Rev 03

    Issue Date : 2025-03-19

    Type : Chemical

    Substance Number : 727

    Status : Valid

     JDMF arrow-down
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    Registration Number : 226MF10092

    Registrant's Address : 114 Marine Chambers, 11, New Marine Lines, Mumbai-400 020, INDIA

    Initial Date of Registration : 2014-05-14

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2025-09-24

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0165

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 52119-008

    Start Marketing Date : 2014-03-20

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Daeshin Pharmaceutical Co., Ltd.

    Registration Date : 2020-10-13

    Registration Number : 20201013-210-J-408

    Manufacturer Name : Swati Spentose Private Limited (Unit-I)

    Manufacturer Address : Plot No. A-1/2102 & 2103, Phase III, GIDC, VAPI, City: Vapi - 396 195, Dist: Valsad, Gujarat State India

     VMF Others AUDIT arrow-down
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    02

    Dutasteride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF CEP/COS arrow-down
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    Certificate Number : CEP 2022-503 - Rev 00

    Issue Date : 2025-03-18

    Type : Chemical

    Substance Number : 2641

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10161

    Registrant's Address : 114 Marine Chambers, 11, New Marine Lines, Mumbai-400 020, INDIA

    Initial Date of Registration : 2018-12-03

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-03-25

    Valid Till : 2028-03-24

    Written Confirmation Number : WC-0419

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Phil International Co., Ltd.

    Registration Date : 2025-06-23

    Registration Number : Su323-2-ND(B)

    Manufacturer Name : Swati Spentose Private Limited (Unit-Ⅱ)

    Manufacturer Address : Plot No. A-1/2110 - 2111, III Phase, GIDC VAPI, City: Vapi - 396 195, Dist. Valsad, Gujarat State, India

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    03

    Lidocaine Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-01-05

    Pay. Date : 2013-09-18

    DMF Number : 25963

    Submission : 2012-03-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2013-103 - Rev 04

    Issue Date : 2025-02-03

    Type : Chemical

    Substance Number : 227

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-24

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0165

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 52119-009

    Start Marketing Date : 2014-03-20

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Daeshin Pharmaceutical Co., Ltd.

    Registration Date : 2020-01-08

    Registration Number : 20200108-210-J-409

    Manufacturer Name : Swati Spentose Private Limited (Unit-I)

    Manufacturer Address : Plot No. - A-1/2102, 2103 & A-2/2120, Phase III, GIDC, Vapi - 396 195, Dist. - Valsad, Gujarat State, INDIA.

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    04

    Melatonin

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34979

    Submission : 2020-08-08

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2023-075 - Rev 03

    Issue Date : 2025-04-25

    Type : Chemical

    Substance Number : 3059

    Status : Valid

     JDMF EU-WCarrow-down
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    Date of Issue : 2025-09-24

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0165

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 52119-017

    Start Marketing Date : 2019-07-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Daeshin Pharmaceutical Co., Ltd.

    Registration Date : 2019-08-01

    Registration Number : Su312-1-ND

    Manufacturer Name : Swati Spentose Private Limited (Unit-I)

    Manufacturer Address : Plot No. - A-1/2102, 2103 & A-2/2120, Phase III, GIDC, Vapi - 396 195 Dist. - Valsad. Gujarat State, INDIA.

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    05

    Meloxicam

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-10-05

    Pay. Date : 2013-09-25

    DMF Number : 18837

    Submission : 2005-09-30

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2014-261 - Rev 02

    Issue Date : 2024-09-13

    Type : Chemical

    Substance Number : 2373

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-24

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0165

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 52119-003

    Start Marketing Date : 2019-02-07

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Hwain Farm Co., Ltd.

    Registration Date : 2025-05-02

    Registration Number : 20171031-148-I-518-11(5)

    Manufacturer Name : Swati Spentose Private Limited

    Manufacturer Address : A-1/2102, 2103 & A-2/2120, Phase -III, GIDC, Vapi -396 195, Dist. -Valsad, Gujarat State, India

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    06

    Prilocaine

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35260

    Submission : 2020-10-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2020-347 - Rev 02

    Issue Date : 2025-09-12

    Type : Chemical

    Substance Number : 1362

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-24

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0165

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 52119-020

    Start Marketing Date : 2023-03-20

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
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    07

    Prilocaine Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35334

    Submission : 2021-01-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2021-035 - Rev 00

    Issue Date : 2025-04-14

    Type : Chemical

    Substance Number : 1363

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-24

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0165

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 52119-016

    Start Marketing Date : 2019-07-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
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    08

    Tamsulosin

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36934

    Submission : 2022-03-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-133 - Rev 02

    Issue Date : 2025-07-29

    Type : Chemical

    Substance Number : 2131

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-24

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0165

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 52119-024

    Start Marketing Date : 2024-01-05

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2023-09-21

    Registration Number : 20230921-209-J-1512

    Manufacturer Name : Swati Spentose Private Limited (Unit-I)

    Manufacturer Address : Plot No. A-1/2102 & 2103 & A-2/2120, Phase III, GIDC, Vapi - 396 195 Dist : Valsad, Gujarat State India

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    09

    Granisetron Hydrochloride

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35147

    Submission : 2020-08-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-24

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0165

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
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    10

    Pentosan Polysulfate Sodium

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25827

    Submission : 2012-02-22

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-24

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0165

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 52119-023

    Start Marketing Date : 2023-01-10

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    01

    Glycopyrrolate Usp

    India
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    Swati Spentose

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38550

    Submission : 2023-09-06

    Status : Active

    Type : II

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    02

    Granisetron Hydrochloride Usp

    India
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35147

    Submission : 2020-08-27

    Status : Active

    Type : II

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    03

    Lidocaine Hydrochloride Usp

    India
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    Virtual BoothSWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.

    Swati Spentose

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-01-05

    Pay. Date : 2013-09-18

    DMF Number : 25963

    Submission : 2012-03-06

    Status : Active

    Type : II

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    04

    Lidocaine Usp

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    Swati Spentose

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-10-06

    Pay. Date : 2013-09-23

    DMF Number : 25830

    Submission : 2012-02-22

    Status : Active

    Type : II

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    05

    Melatonin Usp

    India
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    Swati Spentose

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34979

    Submission : 2020-08-08

    Status : Active

    Type : II

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    06

    Meloxicam

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    Swati Spentose

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-10-05

    Pay. Date : 2013-09-25

    DMF Number : 18837

    Submission : 2005-09-30

    Status : Active

    Type : II

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    07

    Pentosan Polysulfate Sodium

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    Swati Spentose

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25827

    Submission : 2012-02-22

    Status : Active

    Type : II

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    08

    Prilocaine Hydrochloride Usp

    India
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    CPhI Middle East
    Booth #H2.I41
    • fda
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    Virtual BoothSWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.

    Swati Spentose

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35334

    Submission : 2021-01-30

    Status : Active

    Type : II

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    09

    Prilocaine Usp

    India
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    Virtual BoothSWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.

    Swati Spentose

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35260

    Submission : 2020-10-31

    Status : Active

    Type : II

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    10

    Silodosin

    India
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    Virtual BoothSWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.

    Swati Spentose

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36362

    Submission : 2023-03-01

    Status : Active

    Type : II

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    JDMF

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    01

    Dutasteride

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    Virtual BoothSWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.

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    Swati Spentose

    Registration Number : 230MF10161

    Registrant's Address : 114 Marine Chambers, 11, New Marine Lines, Mumbai-400 020, INDIA

    Initial Date of Registration : 2018-12-03

    Latest Date of Registration : 2019-11-15

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    Lidocaine

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    Swati Spentose

    Registration Number : 226MF10092

    Registrant's Address : 114 Marine Chambers, 11, New Marine Lines, Mumbai-400 020, INDIA

    Initial Date of Registration : 2014-05-14

    Latest Date of Registration : 2014-05-14

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    KEY PRODUCTS

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    Inspections and registrations

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    FDA

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    01

    FDA Audited

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    Booth #H2.I41

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-05-31

    Swati Spentose

    City : Vapi

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-05-31

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    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-12-12

    Swati Spentose

    City : Vapi

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-12-12

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    03

    FDA Audited

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    Booth #H2.I41

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-01-12

    Swati Spentose

    City : Vapi

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-01-12

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    04

    FDA Audited

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    Booth #H2.I41

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2016-02-26

    Swati Spentose

    City : Vapi

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2016-02-26

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    ABOUT THIS PAGE

    Contact Swati Spentose and get a quotation

    Swati Spentose is a supplier offers 67 products (APIs, Excipients or Intermediates).

    Find a price of Lidocaine bulk with DMF, CEP, JDMF, WC offered by Swati Spentose

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