Aspen API. More than just an API™

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01 1Aspen API
02 3Symbiotec Pharmalab
03 1Androst Biotech
04 1Curia
05 1Cerata Pharmaceuticals LLP
06 1Axplora
07 1Farmabios SPA
08 1Sanofi
09 1LGM Pharma
10 1Pfizer CentreOne
11 1Symbiotica Speciality Ingredients Sdn Bhd
12 1ASG Biochem
13 1Chemox Pharma
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15 1F.I.S. Fabbrica Italiana Sintetici
16 1Fujifilm Diosynth Biotechnologies
17 1Hubei Zhuxi Humanwell Pharmaceutical
18 1Ipca Laboratories
19 2Jiangsu Jiaerke Pharmaceuticals Group
20 1Letco Medical
21 1Medisca
22 2Pcca
23 1Pfizer Inc
24 1Pharma Source Direct
25 1Shakti Lifescience
26 1Steroid SpA
27 1Sun Pharmaceutical Industries Limited
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29 1Zhejiang Xianju Pharmaceutical Co. Ltd
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01 1WC-0161A2
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01 10009-0027
02 122552-0010
03 138779-0164
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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-11-17
Pay. Date : 2014-02-06
DMF Number : 3857
Submission : 1980-05-21
Status : Active
Type : II
NDC Package Code : 60870-0252
Start Marketing Date : 1999-06-18
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-06-30
Pay. Date : 2015-05-15
DMF Number : 29023
Submission : 2015-01-20
Status : Active
Type : II
Date of Issue : 2022-06-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0010
Start Marketing Date : 2010-04-29
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Androst Biotech delivering high-quality hormone APIs and intermediates with trusted global compliance and competitive excellence.
Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-10-30
Pay. Date : 2017-07-03
DMF Number : 31860
Submission : 2017-08-18
Status : Active
Type : II
NDC Package Code : 65089-0049
Start Marketing Date : 2016-02-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Cerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.
NDC Package Code : 46439-8736
Start Marketing Date : 2011-05-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42305
Submission : 2025-07-22
Status : Active
Type : II
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 : 3220
Submission : 1978-06-14
Status : Inactive
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-06
Pay. Date : 2013-02-14
DMF Number : 4245
Submission : 1981-08-13
Status : Active
Type : II
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