Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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01 7Active
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01 1218MF10586
02 1303MF10123
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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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07 120210603-209-J-1006
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10 120221222-181-I-649-08
11 120260108-181-I-742-09
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01 112866-1018
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03 122552-0019
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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 : 2026-12-31
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 : 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 : 24823-904
Start Marketing Date : 2012-07-10
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Androst Biotech delivering high-quality hormone APIs and intermediates with trusted global compliance and competitive excellence.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
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 : 2026-12-31
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 |
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
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 : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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PharmaCompass offers a list of Estradiol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Estradiol manufacturer or Estradiol supplier for your needs.
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A Estrogens, esterified manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estrogens, esterified, including repackagers and relabelers. The FDA regulates Estrogens, esterified manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estrogens, esterified API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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