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List of Drug Master Files (JDMF) for Bicalutamide Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Excella GmbH & Co. K.G. (1)

02 AARTI INDUSTRIES LIMITED. (1)

03 USV Private Limited (1)

04 Hetero Labs Limited (2)

05 Kekule Pharma Limited. (1)

06 Olon S. p. A. (1)

07 SUN PHARMACEUTICAL INDUSTRIES LTD. (1)

08 Shaanxi Dasheng Pharmaceutical Tech Co. , Ltd. (1)

09 Shilpa Pharma Lifesciences Limited (1)

10 Sumitomo Chemical Co., Ltd. (1)

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01 Bicalutamide (10)

02 Bicalutamide "BT" (1)

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01 China (1)

02 India (7)

03 Italy (1)

04 Japan (1)

05 Luxembourg (1)

URL Supplier Web Content
226MF10046
7-2-A2,Hetero Corporate,Industrial ...
2022-08-03
2014-02-20
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221MF10073
A-4, Madhura Nagar, S. R. Nagar,Hyd...
2009-04-14
2009-04-14
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219MF10221
Strada Rivoltana, km 6/7, 20053 Rod...
2022-10-26
2007-07-06
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303MF10037
F9 of Jiezuo Square, No. 2 South Fe...
2021-02-19
2021-02-19
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225MF10084
Shilpa House, #12-6-214/A1, Hyderab...
2013-04-23
2013-04-23
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222MF10219
2-7-1 Nihonbashi, Chuo-ku, Tokyo
2010-08-10
2010-08-10
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226MF10195
SUN HOUSE, Plot No. 201 B/1, Wester...
2014-10-27
2014-10-27
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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 JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Bicalutamide Drug Master File in Japan (Bicalutamide JDMF) empowers Bicalutamide API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Bicalutamide JDMF during the approval evaluation for pharmaceutical products. At the time of Bicalutamide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Bicalutamide suppliers with JDMF 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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