Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.

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01 7Active
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01 1218MF10532
02 1218MF10626
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01 13923/25
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01 120130610-186-I-285-01
02 120200807-186-I-610-03
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01 122552-0038
02 138779-0364
03 146439-8714
04 146439-8748
05 146439-8785
06 149452-0802
07 151927-0359
08 151927-1641
09 152128-167
10 152221-105
11 153104-7632
12 153183-0407
13 153183-5408
14 163190-0820
15 165089-0010
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Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
Date of Issue : 2025-05-20
Valid Till : 2028-05-22
Written Confirmation Number : 3923/25
Address of the Firm :
NDC Package Code : 52128-167
Start Marketing Date : 2013-03-20
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28137
Submission : 2014-03-20
Status : Active
Type : II
Certificate Number : R1-CEP 2005-062 - Rev 02
Issue Date : 2023-01-27
Type : Chemical
Substance Number : 654
Status : Valid
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0161
Address of the Firm :
NDC Package Code : 22552-0038
Start Marketing Date : 2014-01-28
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-25
Pay. Date : 2019-04-22
DMF Number : 12813
Submission : 1998-01-05
Status : Active
Type : II
Certificate Number : R1-CEP 2001-315 - Rev 02
Issue Date : 2017-06-28
Type : Chemical
Substance Number : 654
Status : Valid
NDC Package Code : 46439-8785
Start Marketing Date : 2025-03-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2013-06-10
Registration Number : 20130610-186-I-285-01
Manufacturer Name : Farmabios SpA
Manufacturer Address : Gropello Cairoli (PV) - Via Pavia, 1, Italy.
| Available Reg Filing : CN, SA |
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8036
Submission : 1989-04-28
Status : Inactive
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-01-31
Pay. Date : 2019-01-28
DMF Number : 4871
Submission : 1983-03-14
Status : Active
Type : II
Certificate Number : CEP 2010-108 - Rev 06
Issue Date : 2025-06-30
Type : Chemical
Substance Number : 654
Status : Valid
| Available Reg Filing : ASMF |
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A Spir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Spir, including repackagers and relabelers. The FDA regulates Spir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Spir 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 Spir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Spir supplier is an individual or a company that provides Spir active pharmaceutical ingredient (API) or Spir finished formulations upon request. The Spir suppliers may include Spir API manufacturers, exporters, distributors and traders.
click here to find a list of Spir suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
We have 51 companies offering Spir
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