Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 2Symbiotec Pharmalab
02 1Gonane Pharma
03 1EUROAPI
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01 7China
02 1France
03 1Germany
04 1Hungary
05 10India
06 1Luxembourg
07 1Mexico
08 1Netherlands
09 1Switzerland
10 6U.S.A
01 7Active
02 4Inactive
03 19Blank
01 1Expired
02 8Valid
03 1Withdrawn by Holder
04 20Blank
01 1218MF10586
02 1303MF10123
03 28Blank
01 1WC-0161A2
02 1WC-0162
03 28Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-04-20
Pay. Date : 2020-03-23
DMF Number : 34147
Submission : 2019-09-11
Status : Active
Type : II
Certificate Number : R0-CEP 2020-067 - Rev 00
Issue Date : 2022-05-05
Type : Chemical
Substance Number : 821
Status : Valid
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162
Address of the Firm :
NDC Package Code : 22552-0019
Start Marketing Date : 2010-05-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Narsha Farm Co., Ltd.
Registration Date : 2022-12-22
Registration Number : 20221222-181-I-649-08
Manufacturer Name : Symbiotec Pharmalab Private Limited
Manufacturer Address : Plot No: 5, 6, 7 & 8, Special Economic Zone, Phase-II, Pharma zone, Pithampur, Dist. Dhar – 454 774(MP), India
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
VMF Number : 6370
Submission : 2020-04-22
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-24
Pay. Date : 2012-11-20
DMF Number : 3829
Submission : 1980-05-21
Status : Active
Type : II
Certificate Number : R2-CEP 1995-001 - Rev 03
Issue Date : 2014-01-30
Type : Chemical
Substance Number : 821
Status : Valid
Registration Number : 218MF10586
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2006-06-22
Latest Date of Registration : --
NDC Package Code : 60870-0217
Start Marketing Date : 1977-09-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Synex Co., Ltd.
Registration Date : 2022-01-13
Registration Number : 20121221-181-I-217-02(A)
Manufacturer Name : Aspen Oss BV
Manufacturer Address : Veersemeer 4, Oss, 5347 JN, The Netherlands
VMF Number : 5875
Submission : 2006-11-01
Status : Active
Type : II
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-27
Pay. Date : 2014-04-24
DMF Number : 22972
Submission : 2009-07-21
Status : Active
Type : II
Certificate Number : CEP 2009-241 - Rev 06
Issue Date : 2023-09-20
Type : Chemical
Substance Number : 821
Status : Valid
Registration Number : 303MF10123
Registrant's Address : Parc Industriel d'Incarville Parc de la Fringale CS 10606 27106 Val de Reuil Cedex France
Initial Date of Registration : 2021-08-02
Latest Date of Registration : --
NDC Package Code : 24823-900
Start Marketing Date : 2011-09-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
NDC Package Code : 51508-016
Start Marketing Date : 2024-04-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
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 : 22552-0019
Start Marketing Date : 2010-05-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Narsha Farm Co., Ltd.
Registration Date : 2022-12-22
Registration Number : 20221222-181-I-649-08
Manufacturer Name : Symbiotec Pharmalab Private Limited
Manufacturer Address : Plot No: 5, 6, 7 & 8, Special Economic Zone, Phase-II, Pharma zone, Pithampur, Dist. Dhar – 454 774(MP), India
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-24
Pay. Date : 2016-04-26
DMF Number : 4066
Submission : 1981-01-21
Status : Active
Type : II
Certificate Number : R1-CEP 1999-040 - Rev 04
Issue Date : 2014-08-12
Type : Chemical
Substance Number : 821
Status : Valid
NDC Package Code : 45541-1124
Start Marketing Date : 1999-03-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29208
Submission : 2015-03-26
Status : Inactive
Type : II
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