Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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01 2WC-0161A2
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01 120121102-181-I-30-01
02 120121221-181-I-217-02
03 120121221-181-I-217-02(A)
04 120121228-181-I-166-03
05 120121228-181-I-166-03(1)
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10 120221222-181-I-649-08
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01 112866-1018
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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 : 2022-06-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0033
Start Marketing Date : 2012-06-27
End Marketing Date : 2025-12-31
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.
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
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 : 60870-0218
Start Marketing Date : 1980-04-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Synex Co., Ltd.
Registration Date : 2022-01-13
Registration Number : 20220113-181-I-637-06
Manufacturer Name : Aspen Oss BV@Aspen Oss BV
Manufacturer Address : Kloosterstraat 6, Oss, 5349 AB, The Netherlands@Veersemeer 4, Oss, 5347 JN, The Netherlands
VMF Number : 5875
Submission : 2006-11-01
Status : Active
Type : II
Available Reg Filing : ASMF, BR, CN |
Date of Issue : 2022-07-23
Valid Till : 2025-02-07
Written Confirmation Number : WC-0162n
Address of the Firm :
Date of Issue : 2022-07-23
Valid Till : 2025-02-07
Written Confirmation Number : WC-0162n
Address of the Firm :
Date of Issue : 2022-06-30
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 : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162Amended
Address of the Firm :
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162Amended
Address of the Firm :
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