Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
01 1Granules India Limited
02 1Aarti Pharmalabs
03 1Supriya Lifescience
04 1Alembic Pharmaceuticals Limited
05 1Aurobindo Pharma Limited
06 1Cadila Pharmaceuticals
07 1Chemeca Drugs
08 2Chemi SpA
09 1Cilag AG
10 1Derivados Quimicos SAU
11 1Dipharma
12 1Divis Laboratories
13 1Emnar Pharma
14 1Erregierre SpA
15 1Glenmark Life Sciences
16 1HANZHONG HANJIANG VENTUREPHARM PHARMACEUTICAL LTD
17 2Hetero Drugs
18 2Hikal
19 1Ipca Laboratories
20 1Jubilant Generics
21 1Lupin Ltd
22 1NORDIC SYNTHESIS AB
23 1Olon S.p.A
24 1Seven Star Pharmaceutical
25 1Sifavitor srl
26 1Solmag
27 1Sun Pharmaceutical Industries Limited
28 1UQUIFA
29 1ZHEJIANG LANGHUA PHARMACEUTICAL
30 1Zhejiang Apeloa Jiayuan Pharmaceutical
31 1Zhejiang Shaxing Pharm. & Chem
32 2Zhejiang Supor Pharmaceuticals Co., LTD
33 2Zydus Lifesciences
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2021-05-27
Pay. Date : 2021-04-15
DMF Number : 35694
Submission : 2021-03-29
Status :
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-19
Pay. Date : 2013-06-25
DMF Number : 27204
Submission : 2013-06-17
Status :
Type : II
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33538
Submission : 2019-01-25
Status :
Type : II
A Bupropion manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bupropion, including repackagers and relabelers. The FDA regulates Bupropion manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bupropion 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 Bupropion manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bupropion supplier is an individual or a company that provides Bupropion active pharmaceutical ingredient (API) or Bupropion finished formulations upon request. The Bupropion suppliers may include Bupropion API manufacturers, exporters, distributors and traders.
click here to find a list of Bupropion suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bupropion DMF (Drug Master File) is a document detailing the whole manufacturing process of Bupropion active pharmaceutical ingredient (API) in detail. Different forms of Bupropion DMFs exist exist since differing nations have different regulations, such as Bupropion USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bupropion DMF submitted to regulatory agencies in the US is known as a USDMF. Bupropion USDMF includes data on Bupropion's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bupropion USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bupropion suppliers with USDMF on PharmaCompass.
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