Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
01 1Porton Pharma Solutions
02 1Fresenius Kabi Oncology Limited
03 1Hetero Drugs
04 1MSN Laboratories
05 1Natco Pharma
06 1Sun Pharmaceutical Industries Limited
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40093
Submission : 2024-06-13
Status :
Type : II
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PharmaCompass offers a list of Alectinib Hydrochloride 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 Alectinib Hydrochloride manufacturer or Alectinib Hydrochloride supplier for your needs.
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PharmaCompass also assists you with knowing the Alectinib Hydrochloride API Price utilized in the formulation of products. Alectinib Hydrochloride API Price is not always fixed or binding as the Alectinib Hydrochloride Price is obtained through a variety of data sources. The Alectinib Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ALECENSA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ALECENSA, including repackagers and relabelers. The FDA regulates ALECENSA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ALECENSA API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A ALECENSA supplier is an individual or a company that provides ALECENSA active pharmaceutical ingredient (API) or ALECENSA finished formulations upon request. The ALECENSA suppliers may include ALECENSA API manufacturers, exporters, distributors and traders.
click here to find a list of ALECENSA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ALECENSA DMF (Drug Master File) is a document detailing the whole manufacturing process of ALECENSA active pharmaceutical ingredient (API) in detail. Different forms of ALECENSA DMFs exist exist since differing nations have different regulations, such as ALECENSA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ALECENSA DMF submitted to regulatory agencies in the US is known as a USDMF. ALECENSA USDMF includes data on ALECENSA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ALECENSA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ALECENSA suppliers with USDMF on PharmaCompass.
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