Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 3Symbiotec Pharmalab
02 1Aspen API
03 1Sichuan Elixir Pharmaceuticals
04 3TAPI Technology & API Services
05 1Dr. Raju’s Pharma Solutions
06 2Merck & Co
07 1Perrigo Company plc
08 1Plantex Ltd.
09 1Wyeth Pharmaceuticals Inc
10 2XINJIANG NUZILINE BIO PHARMACEUTICAL CO LTD
11 2Blank
01 3China
02 3India
03 1Ireland
04 4Israel
05 1Netherlands
06 4U.S.A
07 2Blank
01 4Active
02 10Inactive
03 4Blank
01 1Valid
02 17Blank
01 18Blank
01 1WC-0161A2
02 2WC-0162A2
03 15Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27920
Submission : 2014-02-19
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
NDC Package Code : 22552-0017
Start Marketing Date : 2010-05-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34883
Submission : 2020-06-09
Status : Active
Type : II
NDC Package Code : 60870-0422
Start Marketing Date : 1995-07-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2767
Submission : 1976-11-02
Status : Inactive
Type : II
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
NDC Package Code : 22552-0017
Start Marketing Date : 2010-05-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0017
Start Marketing Date : 2010-05-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13962
Submission : 1999-01-29
Status : Inactive
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15915
Submission : 2002-03-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14046
Submission : 1999-03-31
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-09
Pay. Date : 2015-09-29
DMF Number : 29827
Submission : 2015-09-18
Status : Active
Type : II
NDC Package Code : 70203-101
Start Marketing Date : 2015-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (80mg/80mg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2774
Submission : 1976-10-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3853
Submission : 1980-06-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25337
Submission : 2011-09-30
Status : Inactive
Type : II
Certificate Number : R1-CEP 2010-153 - Rev 00
Issue Date : 2018-02-19
Type : Chemical
Substance Number : 1512
Status : Valid
NDC Package Code : 70203-101
Start Marketing Date : 2015-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (80mg/80mg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 934
Submission : 1965-12-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3011
Submission : 1977-08-24
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7328
Submission : 1988-02-09
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12639
Submission : 1997-09-02
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Premarin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Premarin, including repackagers and relabelers. The FDA regulates Premarin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Premarin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Premarin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Premarin supplier is an individual or a company that provides Premarin active pharmaceutical ingredient (API) or Premarin finished formulations upon request. The Premarin suppliers may include Premarin API manufacturers, exporters, distributors and traders.
click here to find a list of Premarin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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