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List of Drug Master Files (KDMF) for Drospirenone Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Bayer AG@[Micronization process manufacturer] Bayer AG (1)

02 INDUSTRIALE CHIMICA SRL (2)

03 Industriale Chimica srl@LAB-SERVICE SAS (1)

04 NEWCHEM SpA@Microchem SRL (1)

05 Sicor Società Italiana Corticosteroidi Srl (1)

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01 Aging Life Science Co., Ltd. (1)

02 Alvogen Korea Co., Ltd. (1)

03 Bayer Korea Co., Ltd. (1)

04 Hyundai Pharmaceutical Co., Ltd. (1)

05 Samo Pharmaceutical Co., Ltd. (1)

06 Sungjin Exim Co., Ltd. (1)

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01 drospirenone (6)

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01 Germany (1)

02 Italy (5)

URL Supplier Web Content
Bayer Korea Co., Ltd.
2006-03-02
309-2-ND
Bayer AG@[Micronization p...
Germany
Ernst-Schering-Straße 14...
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Hyundai Pharmaceutical Co., Ltd.
2016-12-02
Number 2395-2-ND
INDUSTRIALE CHIMICA SRL
Italy
Via EH Grieg, 13 - 21047 ...
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Alvogen Korea Co., Ltd.
2018-03-12
Number 2395-2-ND(1)
INDUSTRIALE CHIMICA SRL
Italy
Via EH Grieg, 13 - 21047 ...
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Aging Life Science Co., Ltd.
2022-01-10
Number 434-44-ND
Industriale Chimica srl@L...
Italy
Via EH Grieg 13 21047 Sar...
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Sungjin Exim Co., Ltd.
2021-03-12
Wed133-13-ND
NEWCHEM SpA@Microchem SRL
Italy
Via Roveggia, 47, 37136 V...
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Samo Pharmaceutical Co., Ltd.
2013-01-04
711-13-ND
Sicor Società Italiana C...
Italy
13048, Tenuta S. Alessand...
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Looking for 67392-87-4 / Drospirenone API manufacturers, exporters & distributors?

Drospirenone manufacturers, exporters & distributors 1

65

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.

Drospirenone KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Drospirenone Drug Master File in Korea (Drospirenone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Drospirenone. The MFDS reviews the Drospirenone KDMF as part of the drug registration process and uses the information provided in the Drospirenone KDMF to evaluate the safety and efficacy of the drug.

After submitting a Drospirenone KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Drospirenone API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Drospirenone suppliers with KDMF on PharmaCompass.

Drospirenone Manufacturers | Traders | Suppliers

Drospirenone Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Drospirenone

Get in contact with the supplier of your choice:

  1. Bayer AG
  2. Industriale Chimica s.r.l.
  3. NEWCHEM SPA
  4. Sicor Spa
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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