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

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01 Alembic Pharmaceuticals Limited (1)

02 Dottikon Exclusive Synthesis AG (1)

03 Lonza AG (1)

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01 AstraZeneca Korea Co., Ltd. (2)

02 Eltech Pharmachem Co., Ltd. (1)

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01 Olaparib (3)

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01 India (1)

02 Switzerland (1)

03 U.S.A (1)

URL Supplier Web Content
Eltech Pharmachem Co., Ltd.
2022-06-27
Number 469-5-ND
Alembic Pharmaceuticals L...
India
API Division Karakhadi, P...
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AstraZeneca Korea Co., Ltd.
2019-10-29
Wed248-11-ND
Dottikon Exclusive Synthe...
Switzerland
Hembrunnstrasse 17 CH-560...
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AstraZeneca Korea Co., Ltd.
2019-10-29
Wed248-12-ND
Lonza AG
Switzerland
Lonzastrasse, 3930 Visp, ...
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Looking for 763113-22-0 / Olaparib API manufacturers, exporters & distributors?

Olaparib manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Olaparib

Synonyms

763113-22-0, Lynparza, Azd2281, Azd-2281, Ku-0059436, Azd 2281

Cas Number

763113-22-0

Unique Ingredient Identifier (UNII)

WOH1JD9AR8

About Olaparib

Olaparib is a small molecule inhibitor of the nuclear enzyme poly(ADP-ribose) polymerase (PARP) with potential chemosensitizing, radiosensitizing, and antineoplastic activities. Olaparib selectively binds to and inhibits PARP, inhibiting PARP-mediated repair of single strand DNA breaks; PARP inhibition may enhance the cytotoxicity of DNA-damaging agents and may reverse tumor cell chemoresistance and radioresistance. PARP catalyzes post-translational ADP-ribosylation of nuclear proteins and can be activated by single-stranded DNA breaks.

Olaparib Manufacturers

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

Olaparib Suppliers

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

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

Olaparib KDMF

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

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

After submitting a Olaparib 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 Olaparib API can apply through the Korea Drug Master File (KDMF).

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

Olaparib Manufacturers | Traders | Suppliers

Olaparib Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Olaparib

Get in contact with the supplier of your choice:

  1. Alembic Pharmaceuticals Limited
  2. DOTTIKON EXCLUSIVE SYNTHESIS AG
  3. Lonza Inc & Lonza America Inc
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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