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01 1Alembic Pharmaceuticals Limited

02 1Cdymax

03 1Cipla

04 1Hetero Drugs

05 2MSN Laboratories

06 1Natco Pharma

07 1Qilu Antibiotics Pharmaceutical Co., Ltd.

08 1SYNTHON Chemicals GmbH & Co. KG

09 1ScinoPharm Taiwan, Ltd

10 1Sichuan Xieli Pharmaceutical

11 1Yabao Pharmaceutical Group Co. Ltd

12 1Zhejiang Hisun Pharmaceutical

13 1Zhejiang Jiuzhou Pharmaceutical

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02

Cosmoprof
Not Confirmed

03

Cosmoprof
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07

Cosmoprof
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08

Cosmoprof
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08

Cosmoprof
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GDUFA

DMF Review : Complete

Rev. Date : 2016-06-27

Pay. Date : 2015-11-19

DMF Number : 29797

Submission : 2015-11-17

Status : Active

Type : II

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Gefitinib Manufacturers

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

Gefitinib Suppliers

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

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

Gefitinib USDMF

A Gefitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Gefitinib active pharmaceutical ingredient (API) in detail. Different forms of Gefitinib DMFs exist exist since differing nations have different regulations, such as Gefitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Gefitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Gefitinib USDMF includes data on Gefitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gefitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Gefitinib suppliers with USDMF on PharmaCompass.

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.