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List of all Manufacturers, Suppliers & Exporters of Levonorgestrel API listed on PharmaCompass with details of regulatory filings

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01 Hubei Gedian Humanwell Pharmaceutical (1)

02 LGM Pharma (1)

03 Symbiotec Pharmalab (2)

04 3M Drug Delivery Systems (1)

05 ASG Biochem (1)

06 Arudavis Labs (1)

07 Balaji Corporation (1)

08 Bayer AG (4)

09 CHEMO (1)

10 Cipla (1)

11 FORTEQ NIDAU AG (1)

12 Formosa Laboratories (1)

13 Gedeon Richter (3)

14 Guangzhou Tosun Pharmaceutical (1)

15 Hangzhou Longshine Bio-Tech (1)

16 Hunan KYX Pharmaceutical (1)

17 Indo Phyto Chemicals Private Ltd (1)

18 Industriale Chimica s.r.l. (1)

19 Jenapharm GmbH & Co KG DE 07745 Jena (1)

20 Lupin Ltd (2)

21 Naari (1)

22 Qinhuangdao Zizhu Pharmaceutical Co., Ltd. (3)

23 ScinoPharm Taiwan, Ltd (2)

24 Sterling Spa (2)

25 Swati Spentose (2)

26 Yangzhou Pharmaceutical Factory (1)

27 Blank (5)

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01 China (8)

02 Germany (5)

03 Hungary (3)

04 India (12)

05 Italy (3)

06 Spain (1)

07 Switzerland (1)

08 Taiwan (3)

09 U.S.A (2)

10 Blank (5)

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01 Active (18)

02 Inactive (10)

03 Blank (15)

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01 Valid (9)

02 Withdrawn by EDQM Failure to CEP procedure (1)

03 Withdrawn by Holder (1)

04 Blank (32)

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01 218MF10828 (1)

02 221MF10183 (1)

03 221MF10292 (1)

04 228MF10159 (1)

05 Blank (39)

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01 HB230032 (1)

02 WC-0161A2 (1)

03 WC-0162 (1)

04 WC-0297 (1)

05 WC-297 (1)

06 Blank (38)

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

Application Number
33000
R0-CEP 2022-199 - Rev 00
HB230032
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2026-11-12
Filing Details
LEVONORGESTREL
Levonorgestrel, Non-micronised and ...
Levonorgestrel
Issue/Submission Date
2022-06-24
2023-05-19
2023-11-13
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

Application Number
27867
Indian CDSCO WC-0162
Status
Active
Fees Paid
Reviewed
 
Valid
2025-07-02
Filing Details
LEVONORGESTREL EP/USP, MICRONIZED
Levonorgestrel (BP/ Ph.Eur /USP)
Issue/Submission Date
2014-01-27
2022-08-31
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

Application Number
Indian CDSCO WC-0161A2
Status
 
Valid
2025-07-02
Filing Details
Levonorgestrel BP/EP/USP
Issue/Submission Date
2022-07-05
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USDMF

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CEP/COS

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Written Confirmation

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Application Number
37443
Status
Active
Fees Unpaid
N/A
 
Filing Details
LEVONORGESTREL
Issue/Submission Date
2022-09-13
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USDMF

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Application Number
21547
Status
Active
Fees Paid
N/A
 
Filing Details
LEVONORGESTREL USP
Issue/Submission Date
2008-07-03
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
4178
R1-CEP 2000-101 - Rev 03
218MF10828
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
LEVONORGESTREL
Levonorgestrel, Micro 20
Norgestrel at Kaiser-Wilhelm-Allee ...
Issue/Submission Date
1981-05-21
2017-03-03
2006-10-20
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
16696
R1-CEP 2003-127 - Rev 02
221MF10183
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
LEVONORGESTREL USP
Levonorgestrel
Levonorgestrel at Via E. H. Grieg, ...
Issue/Submission Date
2003-07-07
2012-03-06
2009-08-13
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USDMF

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CEP/COS

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Application Number
17307
Status
Active
Fees Paid
N/A
 
Filing Details
NORGESTREL
Issue/Submission Date
2004-04-16
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
27692
R0-CEP 2022-225 - Rev 00
Status
Active
Fees Unpaid
N/A
Valid
 
Filing Details
LEVONORGESTREL (MICRONIZED)
Levonorgestrel, Micronised, Process...
Issue/Submission Date
2013-10-20
2022-12-20
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USDMF

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Application Number
26830
Status
Active
Fees Unpaid
N/A
 
Filing Details
MIRENA® INSERTER PROJECT
Issue/Submission Date
2013-01-31
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USDMF

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Application Number
17067
221MF10292
Status
Active
Fees Paid
Reviewed
 
Filing Details
LEVONORGESTREL USP
Levonorgestrel at No. 1, Nan-Ke 8th...
Issue/Submission Date
2003-12-31
2009-12-25
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USDMF

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Application Number
14923
Status
Active
Fees Paid
N/A
 
Filing Details
CLIMARA PRO(R) ESTRADIOL/LEVONORGES...
Issue/Submission Date
2000-06-16
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USDMF

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CEP/COS

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Written Confirmation

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Application Number
21634
228MF10159
Status
Active
Fees Paid
Reviewed
 
Filing Details
LEVONORGESTREL
Levonorgestrel at 36 Hoping Street,...
Issue/Submission Date
2008-05-20
2016-08-10
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USDMF

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Application Number
10218
Status
Inactive
Fees Paid
N/A
 
Filing Details
NORPLANT (LEVONORGESTREL IMPLANTS)
Issue/Submission Date
1993-05-04
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USDMF

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Application Number
18403
Status
Inactive
Fees Paid
N/A
 
Filing Details
LEVONORGESTREL (DCM)
Issue/Submission Date
2005-06-02
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USDMF

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Written Confirmation

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Application Number
26064
Indian CDSCO WC-297
Status
Inactive
Fees Unpaid
N/A
 
Expired
2021-11-04
Filing Details
LEVONORGESTREL USP
Levonorgestrel (IP/BP/USP)
Issue/Submission Date
2012-05-19
2018-11-05
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USDMF

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Application Number
12934
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
LEVONORGESTREL USP 23
Issue/Submission Date
1998-03-20
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USDMF

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Application Number
17068
Status
Inactive
Fees Paid
N/A
 
Filing Details
NORGESTREL USP
Issue/Submission Date
2003-12-31
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USDMF

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Written Confirmation

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Application Number
Indian CDSCO WC-0297
Status
 
Valid
2024-11-05
Filing Details
Levonorgestrel
Issue/Submission Date
2022-09-01
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USDMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
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USDMF

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Application Number
R1-CEP 2006-218 - Rev 01
Status
Withdrawn by Holder
 
Filing Details
Levonorgestrel
Issue/Submission Date
2014-02-27
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USDMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
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USDMF

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Application Number
R1-CEP 2013-237 - Rev 00
Status
Valid
 
Filing Details
Levonorgestrel, Micronised
Issue/Submission Date
2019-04-30
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USDMF

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CEP/COS

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Application Number
R1-CEP 1996-031 - Rev 02
Status
Withdrawn by EDQM Failure to CEP procedure
 
Filing Details
Levonorgestrel
Issue/Submission Date
2006-12-03
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USDMF

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Application Number
5156
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
LEVONORGESTREL MICROCAPSULES
Issue/Submission Date
1983-09-22
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USDMF

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Application Number
6175
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
LEVONORGESTREL INTRAUTERINE DEVICE
Issue/Submission Date
1986-01-27
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USDMF

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Application Number
6225
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
LEVONORGESTREL MICROCAPSULES
Issue/Submission Date
1986-02-20
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USDMF

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Application Number
12994
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
LEVONORGESTREL, USP
Issue/Submission Date
1998-05-18
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USDMF

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Application Number
14288
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
LEVONORGESTREL
Issue/Submission Date
1999-07-12
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Looking for 797-63-7 / Levonorgestrel API manufacturers, exporters & distributors?

Levonorgestrel manufacturers, exporters & distributors 1

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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, Price,and more, enabling you to easily find the right Levonorgestrel manufacturer or Levonorgestrel supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Levonorgestrel manufacturer or Levonorgestrel supplier.

PharmaCompass also assists you with knowing the Levonorgestrel API Price utilized in the formulation of products. Levonorgestrel API Price is not always fixed or binding as the Levonorgestrel Price is obtained through a variety of data sources. The Levonorgestrel Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Levonorgestrel

Synonyms

Norgestrel, 797-63-7, D-norgestrel, Mirena, (-)-norgestrel, Levonova

Cas Number

797-63-7

Unique Ingredient Identifier (UNII)

5W7SIA7YZW

About Levonorgestrel

A synthetic progestational hormone with actions similar to those of PROGESTERONE and about twice as potent as its racemic or (+-)-isomer (NORGESTREL). It is used for contraception, control of menstrual disorders, and treatment of endometriosis.

Levonorgestrel Manufacturers

A Levonorgestrel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levonorgestrel, including repackagers and relabelers. The FDA regulates Levonorgestrel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levonorgestrel 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 Levonorgestrel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Levonorgestrel Suppliers

A Levonorgestrel supplier is an individual or a company that provides Levonorgestrel active pharmaceutical ingredient (API) or Levonorgestrel finished formulations upon request. The Levonorgestrel suppliers may include Levonorgestrel API manufacturers, exporters, distributors and traders.

click here to find a list of Levonorgestrel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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