Company profile for Swati Spentose

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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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DATA COMPILATION #PharmaFlow

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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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https://www.pharmacompass.com/radio-compass-blog/chinese-fda-registered-generic-facilities-gain-steam-india-maintains-lead-with-396-facilities

#PharmaFlow by PHARMACOMPASS
21 Nov 2024

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

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

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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Swati Spentose

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2025-01-14

Registration Number : Su258-26-ND

Manufacturer Name : Swati Spentose Private Limited...

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

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02

Swati Spentose

Registrant Name : Phil International Co., Ltd.

Registration Date : 2025-06-23

Registration Number : Su323-2-ND(B)

Manufacturer Name : Swati Spentose Private Limited...

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

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03

Swati Spentose

Registrant Name : Daeshin Pharmaceutical Co., Ltd.

Registration Date : 2021-06-22

Registration Number : Su323-2-ND

Manufacturer Name : Swati Spentose Private Limited...

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

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04

Swati Spentose

Registrant Name : Sanil Pharma Co., Ltd.

Registration Date : 2025-01-14

Registration Number : Su323-2-ND(1)

Manufacturer Name : Swati Spentose Private Limited...

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

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05

Swati Spentose

Registrant Name : Samoh Pharmaceutical Co., Ltd.

Registration Date : 2025-01-13

Registration Number : Su323-2-ND(A)

Manufacturer Name : Swati Spentose Private Limited...

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

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Swati Spentose

Registrant Name : Sanil Pharma Co., Ltd.

Registration Date : 2025-06-11

Registration Number : 20250611-210-J-1912

Manufacturer Name : Swati Spentose Private Limited...

Manufacturer Address : Plot No. A-1/2102, 2103 & A-2/2120, Phase III, GIDC, VAPI - 396 195, Dist : Valsad, G...

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07

Swati Spentose

Registrant Name : Daeshin Pharmaceutical Co., Ltd.

Registration Date : 2020-10-13

Registration Number : 20201013-210-J-408

Manufacturer Name : Swati Spentose Private Limited...

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

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Swati Spentose

Registrant Name : Daeshin Pharmaceutical Co., Ltd.

Registration Date : 2020-01-08

Registration Number : 20200108-210-J-409

Manufacturer Name : Swati Spentose Private Limited...

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

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Swati Spentose

Registrant Name : Daeshin Pharmaceutical Co., Ltd.

Registration Date : 2019-08-01

Registration Number : Su312-1-ND

Manufacturer Name : Swati Spentose Private Limited...

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

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Swati Spentose

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 St...

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NDC API

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Swati Spentose

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

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02

Swati Spentose

NDC Package Code : 52119-001

Start Marketing Date : 2012-08-20

End Marketing Date : 2026-12-31

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

Marketing Category : BULK INGREDIENT

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Swati Spentose

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

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Swati Spentose

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

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Swati Spentose

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

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LISTED APIs

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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, AF...
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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Swati Spentose

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.

About the Company : 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...

Company Banner
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, AF...
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.
Company Banner

02

Swati Spentose

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.

About the Company : 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...

Company Banner
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, AF...
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.
Company Banner

03

Swati Spentose

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.

About the Company : 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...

Company Banner
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, AF...
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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04

Swati Spentose

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.

About the Company : 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...

Company Banner
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, AF...
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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05

Swati Spentose

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.

About the Company : 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...

Company Banner
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, AF...
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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06

Swati Spentose

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.

About the Company : 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...

Company Banner
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, AF...
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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07

Swati Spentose

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.

About the Company : 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...

Company Banner
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, AF...
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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08

Swati Spentose

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.

About the Company : 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...

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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, AF...
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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09

Swati Spentose

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.

About the Company : 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...

Company Banner
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, AF...
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.
Company Banner

10

Swati Spentose

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.

About the Company : 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...

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FDF Dossiers

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01

Brand Name : Glycopyrrolate

Swati Spentose

Dosage Form : Tablet

Brand Name : Glycopyrrolate

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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02

Brand Name : Glycopyrrolate

Swati Spentose

Dosage Form : Tablet

Brand Name : Glycopyrrolate

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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03

Brand Name : Glycopyrrolate

Swati Spentose

Dosage Form : Oral Solution

Brand Name : Glycopyrrolate

Dosage Strength : 1MG/5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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04

Brand Name : Granisetron

Swati Spentose

Dosage Form : Tablet

Brand Name : Granisetron

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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05

Brand Name : Granisetron

Swati Spentose

Dosage Form : Injection

Brand Name : Granisetron

Dosage Strength : 1MG/1ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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06

Brand Name : Lidocaine

Swati Spentose

Dosage Form : Injection

Brand Name : Lidocaine

Dosage Strength : 2%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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07

Brand Name : Lidocaine

Swati Spentose

Dosage Form : Gel

Brand Name : Lidocaine

Dosage Strength : 2%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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08

Brand Name : Melatonin

Swati Spentose

Dosage Form : Tablet

Brand Name : Melatonin

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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09

Brand Name : Melatonin

Swati Spentose

Dosage Form : Tablet

Brand Name : Melatonin

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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10

Brand Name : Melatonin

Swati Spentose

Dosage Form : Tablet

Brand Name : Melatonin

Dosage Strength : 3MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Listed Dossiers

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01

Brand Name : Glycopyrrolate

Swati Spentose

Dosage Form : Tablet

Brand Name : Glycopyrrolate

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Company Banner

02

Brand Name : Glycopyrrolate

Swati Spentose

Dosage Form : Tablet

Brand Name : Glycopyrrolate

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Company Banner

03

Brand Name : Glycopyrrolate

Swati Spentose

Dosage Form : Oral Solution

Brand Name : Glycopyrrolate

Dosage Strength : 1MG/5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Company Banner

04

Brand Name : Granisetron

Swati Spentose

Dosage Form : Tablet

Brand Name : Granisetron

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Company Banner

05

Brand Name : Granisetron

Swati Spentose

Dosage Form : Injection

Brand Name : Granisetron

Dosage Strength : 1MG/1ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Company Banner

06

Brand Name : Lidocaine

Swati Spentose

Dosage Form : Injection

Brand Name : Lidocaine

Dosage Strength : 2%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Company Banner

07

Brand Name : Lidocaine

Swati Spentose

Dosage Form : Gel

Brand Name : Lidocaine

Dosage Strength : 2%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Company Banner

08

Brand Name : Melatonin

Swati Spentose

Dosage Form : Tablet

Brand Name : Melatonin

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Company Banner

09

Brand Name : Melatonin

Swati Spentose

Dosage Form : Tablet

Brand Name : Melatonin

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Company Banner

10

Brand Name : Melatonin

Swati Spentose

Dosage Form : Tablet

Brand Name : Melatonin

Dosage Strength : 3MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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KEY PRODUCTS

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Inspections and registrations

Check the inspections & registration from this company

FDA

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01

FDA Audited

USA

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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02

FDA Audited

USA

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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03

FDA Audited

USA

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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04

FDA Audited

USA

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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05

FDA Audited

USA

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

Company Banner

06

FDA Audited

USA

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

Company Banner

07

FDA Audited

USA

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

Company Banner

08

FDA Audited

USA

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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GDUFA

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01

GDUFA fees paid

USA

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : Swati Spentose Private Limited

Business Address : A-1/2102,2103, Phase III GID...

FEI Number : 3009765202

Country : India

Paid in : 2025

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

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Find a price of Glycopyrronium Bromide bulk with DMF, WC offered by Swati Spentose

Find a price of Granisetron Hydrochloride bulk with DMF, WC offered by Swati Spentose

Find a price of Pentosan Polysulfate Sodium bulk with DMF, WC offered by Swati Spentose

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