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List of Certificates of Suitability (CEPs) for Levonorgestrel Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 Hubei Gedian Humanwell Pharmaceutical Co., Ltd. E-Zhou CN (1)

02 BAYER AG Leverkusen DE (1)

03 GEDEON RICHTER PLC Budapest HU (1)

04 Industriale Chimica S.R.L. Saronno IT (1)

05 Jenapharm GmbH & Co KG Jena DE (1)

06 LUPIN LIMITED Mumbai IN (1)

07 QINHUANGDAO ZIZHU PHARMACEUTICAL CO., LTD. Qinhuangdao City CN (3)

08 STERLING CHEMICAL MALTA LTD. Birzebbugia MT (2)

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01 Levonorgestrel (6)

02 Levonorgestrel, Micro 20 (1)

03 Levonorgestrel, Micronised (1)

04 Levonorgestrel, Micronised, Process II (1)

05 Levonorgestrel, Micronised, code 200318 (1)

06 Levonorgestrel, Non-micronised and micronised (1)

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01 China (4)

02 Germany (2)

03 Hungary (1)

04 India (1)

05 Italy (3)

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01 Valid (9)

02 Withdrawn by EDQM Failure to CEP procedure (1)

03 Withdrawn by Holder (1)

URL Supplier Web Content
R1-CEP 2000-101 - Rev 03
Valid
Chemical
2017-03-03
926
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R1-CEP 1999-141 - Rev 04
Valid
Chemical
2021-12-20
926
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R1-CEP 2003-127 - Rev 02
Valid
Chemical
2012-03-06
926
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R1-CEP 2012-349 - Rev 00
Valid
Chemical
2019-09-26
926
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R0-CEP 2022-225 - Rev 00
Valid
Chemical
2022-12-20
926
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R1-CEP 2013-237 - Rev 00
Valid
Chemical
2019-04-30
926
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R1-CEP 2006-218 - Rev 01
Withdrawn by Holder
Chemical
2014-02-27
2015-07-10
926
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R1-CEP 2015-056 - Rev 00
Valid
Chemical
2023-02-07
926
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R0-CEP 2021-255 - Rev 01
Valid
Chemical
2023-06-16
926
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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.

Levonorgestrel CEP

A Levonorgestrel CEP of the European Pharmacopoeia monograph is often referred to as a Levonorgestrel Certificate of Suitability (COS). The purpose of a Levonorgestrel CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Levonorgestrel EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Levonorgestrel to their clients by showing that a Levonorgestrel CEP has been issued for it. The manufacturer submits a Levonorgestrel CEP (COS) as part of the market authorization procedure, and it takes on the role of a Levonorgestrel CEP holder for the record. Additionally, the data presented in the Levonorgestrel CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Levonorgestrel DMF.

A Levonorgestrel CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Levonorgestrel CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Levonorgestrel suppliers with CEP (COS) on PharmaCompass.

Levonorgestrel Manufacturers | Traders | Suppliers

Levonorgestrel Manufacturers, Traders, Suppliers 1
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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