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Shijiazhuang Cansav Pharmaceutical T...

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USDMF

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 40785

Submission : 2024-11-11

Status : Active

Type : II

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Ambroxol Hydrochloride Manufacturers

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

Ambroxol Hydrochloride Suppliers

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

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

Ambroxol Hydrochloride USDMF

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

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

click here to find a list of Ambroxol Hydrochloride 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.