Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.

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02 1ACS DOBFAR SPA
03 1ADL BioPharma
04 1Anhui Sinotech Industrial
05 1Arcadia Lifescience
06 3Aurobindo Pharma Limited
07 3Bristol Myers Squibb
08 1CSPC Pharmaceutical Group
09 1Centrient Pharmaceuticals
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23 1Plantex Ltd.
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31 1YUNGJIN PHARM. CO. LTD
32 1Zhuhai United Laboratories Co ., Ltd.
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01 1Canada
02 8China
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04 1Hong Kong
05 10India
06 2Israel
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09 1Oman
10 1South Korea
11 2Spain
12 1Sweden
13 2Switzerland
14 4U.S.A
15 3United Kingdom
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01 12Active
02 23Inactive
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01 10Valid
02 2Withdrawn by EDQM Failure to CEP procedure
03 3Withdrawn by Holder
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01 1219MF10142
02 1222MF10149
03 1230MF10038
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01 1WC-0121
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01 48Blank
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01 132903-014
02 152946-0810
03 159651-771
04 165862-275
05 165862-461
06 166558-0060
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01 15319
02 15921
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Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35735
Submission : 2021-03-26
Status : Active
Type : II
Certificate Number : R0-CEP 2020-133 - Rev 00
Issue Date : 2022-04-05
Type : Chemical
Substance Number : 168
Status : Valid
NDC Package Code : 32903-014
Start Marketing Date : 2023-11-20
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41293
Submission : 2025-02-26
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38056
Submission : 2023-03-30
Status : Active
Type : II
Certificate Number : CEP 2022-507 - Rev 00
Issue Date : 2024-05-21
Type : Chemical
Substance Number : 168
Status : Valid

GDUFA
DMF Review : Reviewed
Rev. Date : 2017-08-01
Pay. Date : 2016-10-14
DMF Number : 30815
Submission : 2016-08-02
Status : Active
Type : II
Certificate Number : R1-CEP 2002-178 - Rev 02
Issue Date : 2015-02-16
Type : Chemical
Substance Number : 168
Status : Withdrawn by Holder

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13408
Submission : 1998-09-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13438
Submission : 1998-09-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13514
Submission : 1998-09-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13364
Submission : 1998-09-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13728
Submission : 1998-09-01
Status : Inactive
Type : II

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A Cymbi manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cymbi, including repackagers and relabelers. The FDA regulates Cymbi manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cymbi 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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A Cymbi supplier is an individual or a company that provides Cymbi active pharmaceutical ingredient (API) or Cymbi finished formulations upon request. The Cymbi suppliers may include Cymbi API manufacturers, exporters, distributors and traders.
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