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

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01 Hubei Gedian Humanwell Pharmaceutical (1)

02 LGM Pharma (1)

03 Shanghai Minbiotech (1)

04 Symbiotec Pharmalab (2)

05 ASG Biochem (1)

06 Aurisco Pharmaceutical (1)

07 Bayer AG (1)

08 CHEMO (1)

09 Cipla (1)

10 Curia (1)

11 Gedeon Richter (4)

12 Guangzhou Tosun Pharmaceutical (1)

13 Hangzhou Deli Chemical (1)

14 Industriale Chimica s.r.l. (2)

15 Lupin Ltd (1)

16 NEWCHEM SPA (2)

17 Nanjing Bold Chemical (1)

18 Qingdao Qingmei Biotech (1)

19 Sicor Societa Italiana Corticosteroidi Srl (1)

20 Sterling Spa (1)

21 Sun Pharmaceutical Industries Limited (1)

22 Swati Spentose (1)

23 Symbiotica Specialty Ingredients (1)

24 Teva API (1)

25 Teva Pharmaceutical Industries (1)

26 Zhejiang Xianju Junye Pharmaceutical Co. LTD (1)

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01 China (8)

02 Germany (1)

03 Hungary (4)

04 India (7)

05 Israel (2)

06 Italy (6)

07 Malaysia (1)

08 Spain (1)

09 U.S.A (2)

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01 Active (10)

02 Blank (22)

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01 Valid (14)

02 Withdrawn by Holder (1)

03 Blank (17)

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01 303MF10024 (1)

02 305MF10096 (1)

03 305MF10112 (1)

04 Blank (29)

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01 WC-0161A2 (1)

02 WC-0162 (1)

03 WC-0168 (1)

04 Blank (29)

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USDMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Shanghai Minbiotech CB

2024 Spring Meeting

Not Confirmed

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USDMF

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CEP/COS

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Application Number
32885
R0-CEP 2018-118 - Rev 00
Indian CDSCO WC-0161A2
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
DROSPIRENONE USP
Drospirenone
Drospirenone EP/USP
Issue/Submission Date
2018-08-30
2019-09-05
2022-07-05
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USDMF

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CEP/COS

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Application Number
Indian CDSCO WC-0162
Status
 
Valid
2025-07-02
Filing Details
Drospirenone USP/EP
Issue/Submission Date
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

Close WC

Application Number
20676
R1-CEP 2010-081 - Rev 00
303MF10024
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
DROSPIRENONE USP
Drospirenone
Drospirenone at Via E. H. Grieg, 13...
Issue/Submission Date
2007-07-11
2016-03-24
2021-02-01
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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
22802
R1-CEP 2015-247 - Rev 01
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
DROSPIRENONE
Drospirenone, Micronised, non-micro...
Issue/Submission Date
2009-05-15
2023-08-01
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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
36709
R0-CEP 2021-370 - Rev 01
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
DROSPIRENONE EP/USP
Drospirenone, Micronised, non-micro...
Issue/Submission Date
2022-01-26
2023-07-21
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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
17866
R0-CEP 2022-278 - Rev 01
305MF10112
Status
Active
Fees Unpaid
N/A
Valid
 
Filing Details
DROSPIRENONE USP
Drospirenone, Process 2
Drospirenone at BUDAPEST, GYOMROI U...
Issue/Submission Date
2004-12-03
2023-07-31
2023-09-26
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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
12138
R1-CEP 2009-070 - Rev 02
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
DROSPIRENONE
Drospirenone, Micronised (micro 15)
Issue/Submission Date
1996-09-09
2022-07-27
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USDMF

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Japanese DMF

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Written Confirmation

Caution WC

Application Number
23580
Indian CDSCO WC-0168
Status
Active
Fees Paid
N/A
 
Expired
2022-07-14
Filing Details
DROSPIRENONE USP
Drospirenone USP
Issue/Submission Date
2010-08-16
2019-07-15
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USDMF

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Application Number
22878
Status
Active
Fees Paid
Reviewed
 
Filing Details
DROSPIRENONE
Issue/Submission Date
2009-06-18
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USDMF

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Application Number
23397
Status
Active
Fees Paid
Reviewed
 
Filing Details
DROSPIRENONE USP
Issue/Submission Date
2010-01-12
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USDMF

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CEP/COS

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Application Number
R0-CEP 2022-279 - Rev 00
Status
Valid
 
Filing Details
Drospirenone, Process 2 micronized
Issue/Submission Date
2022-12-01
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USDMF

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Application Number
R1-CEP 2009-402 - Rev 00
Status
Valid
 
Filing Details
Drospirenone
Issue/Submission Date
2015-06-08
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USDMF

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Application Number
R0-CEP 2021-508 - Rev 00
Status
Valid
 
Filing Details
Drospirenone, Process I
Issue/Submission Date
2022-05-30
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USDMF

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Application Number
R0-CEP 2011-021 - Rev 01
Status
Withdrawn by Holder
 
Filing Details
Drospirenone
Issue/Submission Date
2014-07-28
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USDMF

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Application Number
R1-CEP 2012-143 - Rev 00
Status
Valid
 
Filing Details
Drospirenone
Issue/Submission Date
2018-11-05
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Application Number
R1-CEP 2013-336 - Rev 00
Status
Valid
 
Filing Details
Drospirenone, Fine Form
Issue/Submission Date
2019-02-12
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Application Number
305MF10096
Status
 
Filing Details
Drospirenone at Piazzale Luigi Cad...
Issue/Submission Date
2023-08-09
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Application Number
R1-CEP 2012-049 - Rev 01
Status
Valid
 
Filing Details
Drospirenone
Issue/Submission Date
2021-08-25
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Application Number
R1-CEP 2010-014 - Rev 01
Status
Valid
 
Filing Details
Drospirenone
Issue/Submission Date
2022-01-04
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Looking for 67392-87-4 / Drospirenone API manufacturers, exporters & distributors?

Drospirenone manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Drospirenone 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 Drospirenone manufacturer or Drospirenone supplier for your needs.

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

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

API | Excipient name

Drospirenone

Synonyms

67392-87-4, Dihydrospirorenone, Dehydrospirorenone, Drospirenona, 1,2-dihydrospirorenone, Drsp

Cas Number

67392-87-4

Unique Ingredient Identifier (UNII)

N295J34A25

About Drospirenone

Drospirenone is a synthetic spironolactone analogue and progestin with progestational and anti-mineralocorticoid activity. Drospirenone binds to the progesterone receptor, the resulting complex becomes activated and binds to specific sites on DNA. This results in a suppression of LH activity and an inhibition of ovulation as well as an alteration in the cervical mucus and endometrium. This leads to an increased difficulty of sperm entry into the uterus and implantation. This drug is used in oral contraceptives.

Drospirenone Manufacturers

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

Drospirenone Suppliers

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

click here to find a list of Drospirenone 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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