Androst Biotech delivering high-quality hormone APIs and intermediates with trusted global compliance and competitive excellence.

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01 1Androst Biotech
02 1LGM Pharma
03 3Symbiotec Pharmalab
04 2Swati Spentose
05 13M Drug Delivery Systems
06 1ASG Biochem
07 1Aresko Life Sciences
08 1Arudavis Labs
09 1Balaji Corporation
10 2Bayer AG
11 1CHEMO
12 1Cipla
13 1Cohesion Biotec
14 1FORTEQ NIDAU AG
15 1Formosa Laboratories
16 3Gedeon Richter
17 1Guangzhou Tosun Pharmaceutical
18 1Hangzhou Longshine Bio-Tech
19 1Hetero Drugs
20 2Hubei Gedian Humanwell Pharmaceutical
21 2Hunan KYX Pharmaceutical
22 1Indo Phyto Chemicals Private Ltd
23 3Industriale Chimica
24 1Jenapharm GmbH & Co KG DE 07745 Jena
25 1Jiangsu Lianhuan Pharmaceutical
26 2Lupin Ltd
27 1Naari
28 3Qinhuangdao Zizhu Pharmaceutical
29 2ScinoPharm Taiwan Ltd
30 2Sterling Chemical Malta
31 2Sterling Spa
32 1Yangzhou Pharmaceutical Factory
33 1Zhejiang Xianju Pharmaceutical Co. Ltd
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01 12China
02 3Germany
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04 17India
05 5Italy
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09 3Taiwan
10 2U.S.A
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01 22Active
02 8Inactive
03 26Blank
01 10Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 1Withdrawn by Holder
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01 1221MF10183
02 1221MF10292
03 1228MF10159
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01 1HB230032
02 1WC-0161A2
03 1WC-0162Amended
04 1WC-0162n
05 1WC-0297
06 1WC-0330
07 2WC-0419
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01 112866-1010
02 112866-1011
03 122552-0047
04 144132-004
05 144132-012
06 145541-1149
07 145541-1174
08 151508-012
09 151508-203
10 153104-7669
11 159057-001
12 159057-002
13 160722-3025
14 163190-0130
15 163190-0660
16 163190-0850
17 164918-1907
18 164918-1940
19 165129-2003
20 166499-0018
21 181955-0027
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Androst Biotech delivering high-quality hormone APIs and intermediates with trusted global compliance and competitive excellence.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-23
Pay. Date : 2014-01-23
DMF Number : 27867
Submission : 2014-01-27
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 : 22552-0047
Start Marketing Date : 2017-06-08
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Date of Issue : 2025-03-25
Valid Till : 2028-03-24
Written Confirmation Number : WC-0419
Address of the Firm :
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162Amended
Address of the Firm :
Date of Issue : 2022-07-23
Valid Till : 2025-02-07
Written Confirmation Number : WC-0162n
Address of the Firm :
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Date of Issue : 2025-03-25
Valid Till : 2028-03-24
Written Confirmation Number : WC-0419
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-12-02
Pay. Date : 2022-08-15
DMF Number : 33000
Submission : 2022-06-24
Status : Active
Type : II
Certificate Number : CEP 2022-199 - Rev 01
Issue Date : 2025-11-13
Type : Chemical
Substance Number : 926
Status : Valid
Date of Issue : 2023-11-13
Valid Till : 2026-11-12
Written Confirmation Number : HB230032
Address of the Firm :
NDC Package Code : 51508-203
Start Marketing Date : 2024-11-19
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 : 8806
Submission : 1990-10-30
Status : Active
Type : II
Certificate Number : R1-CEP 1999-141 - Rev 04
Issue Date : 2021-12-20
Type : Chemical
Substance Number : 926
Status : Valid
NDC Package Code : 45541-1149
Start Marketing Date : 2001-07-17
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 : 12934
Submission : 1998-03-20
Status : Inactive
Type : II

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PharmaCompass offers a list of Levonorgestrel API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Levonorgestrel manufacturer or Levonorgestrel supplier for your needs.
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A Microval manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Microval, including repackagers and relabelers. The FDA regulates Microval manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Microval 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 Microval manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Microval supplier is an individual or a company that provides Microval active pharmaceutical ingredient (API) or Microval finished formulations upon request. The Microval suppliers may include Microval API manufacturers, exporters, distributors and traders.
click here to find a list of Microval suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
We have 33 companies offering Microval
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