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    Company profile for Saptalis pharm

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    About

    Saptalis Pharmaceuticals LLC was founded in 2015 with a goal to build a successful pharmaceutical company focused on the development, manufacturing and commercialization of specialty generic prescription (Rx) and Over-The- Counter (OTC) products. Saptalis operates at a 10,000 sq. ft. R&D facility with highly qualified and experienced team of pharmaceutical formulation scientists, analytical chemists and compliance specialists...
    Saptalis Pharmaceuticals LLC was founded in 2015 with a goal to build a successful pharmaceutical company focused on the development, manufacturing and commercialization of specialty generic prescription (Rx) and Over-The- Counter (OTC) products. Saptalis operates at a 10,000 sq. ft. R&D facility with highly qualified and experienced team of pharmaceutical formulation scientists, analytical chemists and compliance specialists in regulatory affairs and pharmaceutical product manufacturing. The facility is fully equipped with state of the art equipment used in pharmaceutical product development and analytical method development

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    CONTACT DETAILS

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    Saptalis pharmUnited_States_of_America Flag
    Country
    Country
    U.S.A
    Address
    Address
    45 Davids Dr Hauppauge, NY 11788
    Telephone
    Telephone
    +(631) 231-2751
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.saptalis.com/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/saptalis-pharmaceutcals-llc/
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    YouTube
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    Twitter

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    NEWS #PharmaBuzz

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    Saptalis Pharmaceuticals Launches Fluoxetine Oral Solution
    Saptalis Pharmaceuticals Launches Fluoxetine Oral Solution

    18 Jun 2025

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20250618093628/en/Saptalis-Pharmaceuticals-Launches-Fluoxetine-Oral-Solution-USP-20-mg5-mL

    BUSINESSWIRE
    18 Jun 2025
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    Saptalis Pharmaceuticals Launches Likmez® Oral Suspension
    Saptalis Pharmaceuticals Launches Likmez® Oral Suspension

    20 May 2025

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20250520874040/en/Saptalis-Pharmaceuticals-Announces-the-Launch-of-LIKMEZ-The-First-and-Only-US-FDA-Approved-Ready-to-Use-Oral-Suspension-of-Metronidazole

    BUSINESSWIRE
    20 May 2025
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    Saptalis`s Generics Glycopyrrolate Receives Approval in US
    Saptalis`s Generics Glycopyrrolate Receives Approval in US

    07 Oct 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216297

    FDA
    07 Oct 2024
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    Saptalis pharm`s Generic Cyclosporine Receives Approval in U.S
    Saptalis pharm`s Generic Cyclosporine Receives Approval in U.S

    05 Jul 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211943

    FDA
    05 Jul 2024
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    Saptalis pharm`s Generic Lithium Citrate Receives Approval in the U.S.
    Saptalis pharm`s Generic Lithium Citrate Receives Approval in the U.S.

    18 Mar 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217183

    FDA
    18 Mar 2024
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    Appili Tx Expands ATI-1501 Commercial Agreement with Saptalis Pharmaceuticals
    Appili Tx Expands ATI-1501 Commercial Agreement with Saptalis Pharmaceuticals

    08 Feb 2022

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20220208005344/en

    BUSINESSWIRE
    08 Feb 2022
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    FDA Orange Book

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    01

    Brand Name : VOSOL HC

    U.S.A
    IPPE
    Not Confirmed
    arrow

    Brand Name : VOSOL HC

    U.S.A
    IPPE
    Not Confirmed
    arrow
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    RLD : Yes

    TE Code : AT

    ACETIC ACID, GLACIAL; HYDROCORTISONE

    Saptalis pharm

    Dosage Form : SOLUTION/DROPS; OTIC

    Proprietary Name : VOSOL HC

    Dosage Strength : 2%;1%

    Approval Date : 1982-01-01

    Application Number : 12770

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AT

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    02

    Brand Name : SONAZINE

    U.S.A
    IPPE
    Not Confirmed
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    Brand Name : SONAZINE

    U.S.A
    IPPE
    Not Confirmed
    arrow
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    RLD : No

    TE Code :

    CHLORPROMAZINE HYDROCHLORIDE

    Saptalis pharm

    Dosage Form : CONCENTRATE; ORAL

    Proprietary Name : SONAZINE

    Dosage Strength : 30MG/ML

    Approval Date : 1982-01-01

    Application Number : 80983

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    03

    Brand Name : SONAZINE

    U.S.A
    IPPE
    Not Confirmed
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    Brand Name : SONAZINE

    U.S.A
    IPPE
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    RLD : No

    TE Code :

    CHLORPROMAZINE HYDROCHLORIDE

    Saptalis pharm

    Dosage Form : CONCENTRATE; ORAL

    Proprietary Name : SONAZINE

    Dosage Strength : 100MG/ML

    Approval Date : 1982-01-01

    Application Number : 80983

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    04

    Brand Name : CLOBETASOL PROPIONAT...

    U.S.A
    IPPE
    Not Confirmed
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    Brand Name : CLOBETASOL PROPIONAT...

    U.S.A
    IPPE
    Not Confirmed
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    RLD : No

    TE Code : AT

    CLOBETASOL PROPIONATE

    Saptalis pharm

    Dosage Form : SOLUTION; TOPICAL

    Proprietary Name : CLOBETASOL PROPIONATE

    Dosage Strength : 0.05%

    Approval Date : 2019-10-02

    Application Number : 211494

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AT

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    05

    Brand Name : CYCLOSPORINE

    U.S.A
    IPPE
    Not Confirmed
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    Brand Name : CYCLOSPORINE

    U.S.A
    IPPE
    Not Confirmed
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    RLD : No

    TE Code : AB

    CYCLOSPORINE

    Saptalis pharm

    Dosage Form : EMULSION; OPHTHALMIC

    Proprietary Name : CYCLOSPORINE

    Dosage Strength : 0.05%

    Approval Date : 2024-07-05

    Application Number : 211943

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    06

    Brand Name : NEOMYCIN AND POLYMYX...

    U.S.A
    IPPE
    Not Confirmed
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    Brand Name : NEOMYCIN AND POLYMYX...

    U.S.A
    IPPE
    Not Confirmed
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    RLD : No

    TE Code :

    HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

    Saptalis pharm

    Dosage Form : SOLUTION/DROPS; OTIC

    Proprietary Name : NEOMYCIN AND POLYMYXIN B...

    Dosage Strength : 1%;EQ 3.5MG BASE/ML;10,0...

    Approval Date : 2005-10-31

    Application Number : 65216

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    blank

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    07

    Brand Name : METFORMIN HYDROCHLOR...

    U.S.A
    IPPE
    Not Confirmed
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    Brand Name : METFORMIN HYDROCHLOR...

    U.S.A
    IPPE
    Not Confirmed
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    RLD : No

    TE Code : AB

    METFORMIN HYDROCHLORIDE

    Saptalis pharm

    Dosage Form : SOLUTION; ORAL

    Proprietary Name : METFORMIN HYDROCHLORIDE

    Dosage Strength : 500MG/5ML

    Approval Date : 2020-03-03

    Application Number : 211309

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    08

    Brand Name : LIKMEZ

    U.S.A
    IPPE
    Not Confirmed
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    Brand Name : LIKMEZ

    U.S.A
    IPPE
    Not Confirmed
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    RLD : Yes

    TE Code :

    METRONIDAZOLE

    Saptalis pharm

    Dosage Form : SUSPENSION; ORAL

    Proprietary Name : LIKMEZ

    Dosage Strength : 500MG/5ML

    Approval Date : 2023-09-22

    Application Number : 216755

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    Inspections and registrations

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    FDA

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    01

    FDA Audited

    USA
    IPPE
    Not Confirmed
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    FDA Audited

    USA
    arrow
    IPPE
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-03-17

    Saptalis pharm

    City : Hauppauge

    State : New York

    Country/Area : U.S.A

    Zip : 11788

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-03-17

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    02

    FDA Audited

    USA
    IPPE
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    IPPE
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-03-28

    Saptalis pharm

    City : Hauppauge

    State : New York

    Country/Area : U.S.A

    Zip : 11788

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-03-28

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