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25 Oct 2023
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213758
20 Jul 2023
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214935
12 Jan 2023
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216020
12 Jan 2023
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216020
26 Sep 2022
// PHARMABIZ
14 Sep 2022
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213944
Date of Issue : 2024-01-15
Valid Till : 2027-01-14
Written Confirmation Number : WC-0577
Address of the Firm : Unit-lll, Sy.No.145/A, 145/AA ...
Date of Issue : 2022-11-02
Valid Till : 2025-07-02
Written Confirmation Number : WC-0182
Address of the Firm : Sy.No.239&240,Dothigudem Villa...
Date of Issue : 2022-11-02
Valid Till : 2025-07-02
Written Confirmation Number : WC-0182
Address of the Firm : Sy.No.239&240,Dothigudem Villa...
Date of Issue : 2022-11-02
Valid Till : 2025-07-02
Written Confirmation Number : WC-0182
Address of the Firm : Sy.No.239&240,Dothigudem Villa...
Date of Issue : 2024-01-15
Valid Till : 2027-01-14
Written Confirmation Number : WC-0577
Address of the Firm : Unit-lll, Sy.No.145/A, 145/AA ...
Date of Issue : 2022-11-02
Valid Till : 2025-07-02
Written Confirmation Number : WC-0182
Address of the Firm : Sy.No.239&240,Dothigudem Villa...
Date of Issue : 2022-11-02
Valid Till : 2025-07-02
Written Confirmation Number : WC-0182
Address of the Firm : Sy.No.239&240,Dothigudem Villa...
Date of Issue : 2022-11-02
Valid Till : 2025-07-02
Written Confirmation Number : WC-0182
Address of the Firm : Sy.No.239&240,Dothigudem Villa...
Date of Issue : 2022-11-02
Valid Till : 2025-07-02
Written Confirmation Number : WC-0182
Address of the Firm : Sy.No.239&240,Dothigudem Villa...
Date of Issue : 2022-11-02
Valid Till : 2025-07-02
Written Confirmation Number : WC-0182
Address of the Firm : Sy.No.239&240,Dothigudem Villa...
Registrant Name : Ace Pharma Co., Ltd.
Registration Date : 2020-11-19
Registration Number : Su105-1-ND
Manufacturer Name : Optimus Drugs Private Limited
Manufacturer Address : Sy. No. 239 & 240, Dothigudem Village, Pochampally Mandal, Yadadri-Bhuvanagiri Distri...
Registrant Name : Klasia Co., Ltd.
Registration Date : 2024-06-03
Registration Number : No. 758-12-ND
Manufacturer Name : Optimus Drugs Private Limited
Manufacturer Address : Unit-I, Sy.No.239 & 240, Dothigudem(V), Pochampally(M), Yadari-Bhuvanagiri(D), Telang...
Registrant Name : Taewang Trading Co., Ltd.
Registration Date : 2016-05-17
Registration Number : No. 4692-13-ND(2)
Manufacturer Name : Optimus Drugs (P) Ltd
Manufacturer Address : Sy.No.239 & 240, Dothigudem Village, Pochampally Mandal, Nalgonda District, Andhra Pr...
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2015-07-27
Registration Number : No. 4692-13-ND(1)
Manufacturer Name : Optimus Drugs (P) Ltd
Manufacturer Address : Sy.No.239 & 240, Dothigudem Village, Pochampally Mandal, Nalgonda District, Andhra Pr...
Registrant Name : Sangjin Corporation
Registration Date : 2014-07-04
Registration Number : Number 4692-13-ND
Manufacturer Name : Optimus Drugs (P) Ltd
Manufacturer Address : Sy.No.239 & 240, Dothigudem Village, Pochampally Mandal, Nalgonda District, Andhra Pr...
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2022-01-20
Registration Number : 20220120-209-J-1217
Manufacturer Name : Optimus Drugs Private Limited
Manufacturer Address : Unit-I, Survey No. 239 & 240, Dothigudem Village, Pochampally Mandal, Yadadri-Bhuvana...
Registrant Name : Saehan Pharmaceutical Co., Ltd.
Registration Date : 2022-05-27
Registration Number : Su532-8-ND
Manufacturer Name : Optimus Drugs Private Limited
Manufacturer Address : Sy. No. 239 & 240, Dothigudem Village, Pochampally Mandal, Yadadri-Bhuvanagiri Distri...
Registrant Name : Jeil Pharmaceutical Co., Ltd.
Registration Date : 2015-11-27
Registration Number : No. 3595-4-ND(1)
Manufacturer Name : Optimus Drugs Private Limited
Manufacturer Address : Unit-I, Survey No. 239 & 240, Dothigudem Village, Pochampally Mandal, Yadadri Bhuvana...
Registrant Name : Iksoo Pharmaceutical Co., Ltd.
Registration Date : 2015-08-06
Registration Number : Su3595-4-ND
Manufacturer Name : Optimus Drugs Private Limited
Manufacturer Address : Unit-I, Survey No. 239 & 240, Dothigudem Village, Pochampally Mandal, Yadadri Bhuvana...
Regulatory Info :
Registration Country : USA
Dosage Form : TABLET; ORAL
Brand Name : OBETICHOLIC ACID
Dosage Strength : 10mg
Packaging :
Approval Date :
Application Number : 214935
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : SAFINAMIDE
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 216020
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : SAFINAMIDE
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number : 216020
Regulatory Info :
Registration Country : USA
RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : OBETICHOLIC ACID
Dosage Strength : 10mg
Approval Date :
Application Number : 214935
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : SAFINAMIDE
Dosage Strength : 50MG
Approval Date :
Application Number : 216020
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : SAFINAMIDE
Dosage Strength : 100MG
Approval Date :
Application Number : 216020
RX/OTC/DISCN :
RLD :
TE Code :
Inspections and registrations
Name and address of WHO GMP certified Manufacturer : Optimus Drugs (P) Ltd. Sy.No. 239 & 240, Dothigudem (V), Pochampally Mandal, Nalgonda.
Country : India
API Manufacturer : API MANUFACTURE
FDF Manufacturer :
Facility Name : Optimus Drugs Private Limited
Business Address : Survey No. 239 & 240, Dothig...
FEI Number : 3010419177
Country : India
Paid in : 2019
ABOUT THIS PAGE
Optimus Pharma is a supplier offers 92 products (APIs, Excipients or Intermediates).
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