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

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01 EXCELLA GMBH & CO. KG Feucht DE (1)

02 AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN (1)

03 CIPLA LIMITED Mumbai IN (1)

04 FRESENIUS KABI ONCOLOGY LIMITED Kalyani IN (1)

05 HETERO LABS LIMITED Hyderabad IN (1)

06 KEKULE PHARMA LIMITED Hyderabad IN (1)

07 MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN (1)

08 MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN (1)

09 SHAANXI DASHENG PHARMACEUTICAL TECH CO., LTD. Xi’an CN (1)

10 SYNTHON BV Nijmegen NL (1)

11 TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL (1)

12 Zhejiang Hisun Pharmaceutical Co., Ltd. Taizhou City CN (1)

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01 Bicalutamide (10)

02 Bicalutamide, Form-H1 (1)

03 Bicalutamide, Milled, Milled (Z) (1)

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01 China (2)

02 Germany (1)

03 India (7)

04 Israel (1)

05 Netherlands (1)

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01 Valid (11)

02 Withdrawn by Holder (1)

URL Supplier Web Content
R1-CEP 2012-369 - Rev 00
Valid
Chemical
2021-05-20
2196
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R1-CEP 2012-254 - Rev 02
Valid
Chemical
2023-01-09
2196
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R1-CEP 2012-413 - Rev 00
Valid
Chemical
2019-07-10
2196
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CEP 2019-329 - Rev 01
Valid
Chemical
2024-04-30
2196
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R1-CEP 2012-283 - Rev 01
Valid
Chemical
2023-08-10
2196
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CEP 2017-174 - Rev 02
Valid
Chemical
2023-11-17
2196
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R1-CEP 2012-153 - Rev 01
Valid
Chemical
2021-09-29
2196
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R1-CEP 2012-303 - Rev 01
Valid
Chemical
2021-11-23
2196
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Looking for 90357-06-5 / Bicalutamide API manufacturers, exporters & distributors?

Bicalutamide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Bicalutamide

Synonyms

90357-06-5, Casodex, Bicalutamide (cdx), Calutide, Ici 176334, Ici-176334

Cas Number

90357-06-5

Unique Ingredient Identifier (UNII)

A0Z3NAU9DP

About Bicalutamide

Bicalutamide is a synthetic, nonsteroidal antiandrogen. Bicalutamide competitively binds to cytosolic androgen receptors in target tissues, thereby inhibiting the receptor binding of androgens. This agent does not bind to most mutated forms of androgen receptors. (NCI04)

Bicalutamide Manufacturers

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

Bicalutamide Suppliers

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

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

Bicalutamide CEP

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

A Bicalutamide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bicalutamide 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 Bicalutamide suppliers with CEP (COS) on PharmaCompass.

Bicalutamide Manufacturers | Traders | Suppliers

Bicalutamide 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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