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    Chemistry

    Click the arrow to open the dropdown
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    Also known as: 1134-47-0, Lioresal, 4-amino-3-(4-chlorophenyl)butanoic acid, Kemstro, Baclon, Dl-baclofen
    Molecular Formula
    C10H12ClNO2
    Molecular Weight
    213.66  g/mol
    InChI Key
    KPYSYYIEGFHWSV-UHFFFAOYSA-N
    FDA UNII
    H789N3FKE8
    Baclofen
    A GAMMA-AMINOBUTYRIC ACID derivative that is a specific agonist of GABA-B RECEPTORS. It is used in the treatment of MUSCLE SPASTICITY, especially that due to SPINAL CORD INJURIES. Its therapeutic effects result from actions at spinal and supraspinal sites, generally the reduction of excitatory transmission.
    Baclofen is a gamma-Aminobutyric Acid-ergic Agonist. The mechanism of action of baclofen is as a GABA A Agonist, and GABA B Agonist.
    1 2D Structure

    Baclofen

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-amino-3-(4-chlorophenyl)butanoic acid
    2.1.2 InChI
    InChI=1S/C10H12ClNO2/c11-9-3-1-7(2-4-9)8(6-12)5-10(13)14/h1-4,8H,5-6,12H2,(H,13,14)
    2.1.3 InChI Key
    KPYSYYIEGFHWSV-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1=CC(=CC=C1C(CC(=O)O)CN)Cl
    2.2 Other Identifiers
    2.2.1 UNII
    H789N3FKE8
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Apo Baclofen

    2. Apo-baclofen

    3. Apobaclofen

    4. Atrofen

    5. Awd, Baclofen

    6. Ba-34,647

    7. Ba-34647

    8. Ba34,647

    9. Ba34647

    10. Baclofne Irex

    11. Baclofne-irex

    12. Baclofneirex

    13. Baclofen Awd

    14. Baclophen

    15. Baclospas

    16. Beta-(aminomethyl)-4-chlorobenzenepropanoic Acid

    17. Beta-(p-chlorophenyl)-gamma-aminobutyric Acid

    18. Chlorophenyl Gaba

    19. Ciba-34,647-ba

    20. Ciba34,647ba

    21. Clofen

    22. Gaba, Chlorophenyl

    23. Gen Baclofen

    24. Gen-baclofen

    25. Genbaclofen

    26. Genpharm

    27. Lebic

    28. Liorsal

    29. Lioresal

    30. Nu Baclo

    31. Nu-baclo

    32. Nubaclo

    33. Pcp-gaba

    34. Pms Baclofen

    35. Pms-baclofen

    36. Pmsbaclofen

    2.3.2 Depositor-Supplied Synonyms

    1. 1134-47-0

    2. Lioresal

    3. 4-amino-3-(4-chlorophenyl)butanoic Acid

    4. Kemstro

    5. Baclon

    6. Dl-baclofen

    7. Gabalon

    8. (+-)-baclofen

    9. Baclofene

    10. Baclofeno

    11. Baclofenum

    12. (rs)-baclofen

    13. Beta-(4-chlorophenyl)gaba

    14. 4-amino-3-(4-chlorophenyl)butyric Acid

    15. Ba-34647

    16. Gablofen

    17. Ciba 34,647-ba

    18. (+/-)-baclofen

    19. Dl-4-amino-3-p-chlorophenylbutanoic Acid

    20. Beta-(aminomethyl)-4-chlorobenzenepropanoic Acid

    21. Ba-34,647

    22. Beta-(p-chlorophenyl)-gamma-aminobutyric Acid

    23. Baclofen (r,s)

    24. C 34647ba

    25. Ba 34647

    26. Beta-(aminomethyl)-p-chlorohydrocinnamic Acid

    27. Gamma-amino-beta-(p-chlorophenyl)butyric Acid

    28. Butanoic Acid, 4-amino-3-(4-chlorophenyl)-

    29. Mfcd00055143

    30. Chembl701

    31. Nsc-755906

    32. Benzenepropanoic Acid, Beta-(aminomethyl)-4-chloro-

    33. Chebi:2972

    34. H789n3fke8

    35. (+)-baclofen; (l)-baclofen

    36. Atrofen

    37. Baclophen

    38. Lioresal Intrathecal

    39. Apo-baclofen

    40. Ncgc00015156-11

    41. (rs)-amino-3-(4-chlorophenyl)butyric Acid

    42. Dsstox_cid_2641

    43. 4-amino-3(4-chlorophenyl)butyric Acid

    44. Baclofene [inn-french]

    45. Baclofenum [inn-latin]

    46. .beta.-(aminomethyl)-p-chlorohydrocinnamic Acid

    47. Dsstox_rid_76670

    48. Baclofeno [inn-spanish]

    49. Dsstox_gsid_22641

    50. .beta.-(aminomethyl)-4-chlorobenzenepropanoic Acid

    51. Lioresal (tn)

    52. Kemstro (tn)

    53. Ccris 3722

    54. Sr-01000000107

    55. Einecs 214-486-9

    56. Brn 2104494

    57. Unii-h789n3fke8

    58. Baclofen O

    59. Ipx056

    60. Mfcd01321057

    61. Ipx 056

    62. (y)-baclofen

    63. Prestwick_85

    64. Cas-1134-47-0

    65. (?)-baclofen

    66. Fleqsuvy

    67. Lyvispah

    68. Ozobax

    69. Baclofen [usan:usp:inn:ban:jan]

    70. (a+/-)-baclofen

    71. Spectrum_000066

    72. Baclofen [usan]

    73. Baclofen [inn]

    74. Baclofen [jan]

    75. Baclofen [mi]

    76. Baclofen [vandf]

    77. (.+/-.)-baclofen

    78. (.+/-.)-baklofen

    79. Prestwick0_000085

    80. Prestwick1_000085

    81. Prestwick2_000085

    82. Prestwick3_000085

    83. Spectrum2_000092

    84. Spectrum3_000310

    85. Spectrum4_000245

    86. Spectrum5_000852

    87. Baclofen-[d4] (major)

    88. Baclofen [mart.]

    89. Baclofen [usp-rs]

    90. Baclofen [who-dd]

    91. Biomol-nt_000251

    92. Upcmld-dp142

    93. (±)-baclofen

    94. B 5399

    95. Lopac0_000163

    96. Oprea1_440627

    97. Schembl19333

    98. Bspbio_000010

    99. Bspbio_001880

    100. Kbiogr_000650

    101. Kbioss_000466

    102. Mls000028480

    103. .beta.-(4-chlorophenyl)gaba

    104. Divk1c_000001

    105. Spectrum1500135

    106. Baclofen (jp17/usp/inn)

    107. Hydrocinnamic Acid, .beta.-(aminomethyl)-p-chloro-

    108. Spbio_000044

    109. Spbio_001949

    110. Baclofen [orange Book]

    111. Benzenepropanoic Acid, .beta.-(aminomethyl)-4-chloro-

    112. Bpbio1_000012

    113. Bpbio1_000750

    114. Gtpl1084

    115. Baclofen [ep Monograph]

    116. Baclofen [usp Monograph]

    117. Dtxsid5022641

    118. Hydrocinnamic Acid, Beta-(aminomethyl)-p-chloro-

    119. Upcmld-dp142:001

    120. Bdbm24182

    121. Hms500a03

    122. Kbio1_000001

    123. Kbio2_000466

    124. Kbio2_003034

    125. Kbio2_005602

    126. Kbio3_001380

    127. Baclofen 0.5 Mg/ml In Methanol

    128. Ninds_000001

    129. Hms1568a12

    130. Hms1920e21

    131. Hms2091m03

    132. Hms2095a12

    133. Hms3260b07

    134. Hms3712a12

    135. Pharmakon1600-01500135

    136. ( Inverted Question Mark)-baclofen

    137. Albb-014712

    138. Bcp11844

    139. Bcp32777

    140. Ex-a1378

    141. Hy-b0007

    142. Tox21_110090

    143. Tox21_500163

    144. Bbl010735

    145. Ccg-38910

    146. Cx1358

    147. Nsc329137

    148. Nsc755906

    149. S4840

    150. Stk535284

    151. Akos005174692

    152. Tox21_110090_1

    153. Ac-4530

    154. Db00181

    155. Hs-1001

    156. Lp00163

    157. Mb00475

    158. Nsc 755906

    159. Nsc-329137

    160. Sb67382

    161. Sdccgsbi-0050151.p005

    162. 4-amino-3-(4-chlorophenyl)butanoicacid

    163. 4-amino-3-(p-chlorophenyl)butyric Acid

    164. Idi1_000001

    165. Smp1_000036

    166. Ncgc00015156-04

    167. Ncgc00015156-05

    168. Ncgc00015156-06

    169. Ncgc00015156-07

    170. Ncgc00015156-08

    171. Ncgc00015156-12

    172. Ncgc00015156-13

    173. Ncgc00015156-15

    174. Ncgc00015156-26

    175. Ncgc00015156-28

    176. Ncgc00023843-03

    177. Ncgc00024579-03

    178. Ncgc00024579-04

    179. Ncgc00024579-05

    180. Ncgc00024579-06

    181. Ncgc00260848-01

    182. Bb166152

    183. Smr000058294

    184. Sy023865

    185. Sy052300

    186. Sbi-0050151.p004

    187. (+/-)-baclofen, >=98% (tlc), Solid

    188. 4-amino-3-(4-chlorophenyl)butanoic Acid #

    189. Ab00051921

    190. Eu-0100163

    191. Ft-0622547

    192. Ft-0662468

    193. Ft-0662469

    194. (rs)-4-amino-3-(4-chlorophenyl)butanoic Acid

    195. D00241

    196. Ab00051921_16

    197. .beta.-(p-chlorophenyl)-.gamma.-aminobutyric Acid

    198. .gamma.-amino-.beta.-(p-chlorophenyl)butyric Acid

    199. 134b470

    200. L000002

    201. Q413717

    202. J-002965

    203. Sr-01000000107-2

    204. Sr-01000000107-4

    205. Sr-01000000107-6

    206. Sr-01000000107-8

    207. Brd-a84174873-001-05-2

    208. (+/- )-beta-(aminomethyl)-4-chlorobenzenepropanoic Acid

    209. Baclofen, British Pharmacopoeia (bp) Reference Standard

    210. Baclofen, European Pharmacopoeia (ep) Reference Standard

    211. F2173-1127

    212. Stx209; Stx-209; Stx 209; D-baclofen; Arbaclofen

    213. Baclofen Lioresal 4-amino-3-(4-chlorophenyl)butyric Acid

    214. Baclofen, United States Pharmacopeia (usp) Reference Standard

    215. N-boc-(2s,3s)-2-hydroxy-3-amino-5-methylhexanoicacid

    216. Baclofen, Pharmaceutical Secondary Standard; Certified Reference Material

    217. Baclofen Solution, 500 Mug/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

    218. Baclofen Solution, 500 Mug/ml (90:10 Meoh:dmso), Certified Reference Material, Ampule Of 1 Ml

    219. Brivaracetam-d3 Solution, 100 Mug/ml In Methanol, Certified Reference Material, Ampule Of 1 Ml

    2.4 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 213.66 g/mol
    Molecular Formula C10H12ClNO2
    XLogP3-1
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count4
    Exact Mass213.0556563 g/mol
    Monoisotopic Mass213.0556563 g/mol
    Topological Polar Surface Area63.3 Ų
    Heavy Atom Count14
    Formal Charge0
    Complexity191
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameBaclofen
    PubMed HealthBaclofen
    Drug ClassesAnalgesic, Skeletal Muscle Relaxant, Centrally Acting
    Drug LabelLIORESAL INTRATHECAL (baclofen injection) is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid, and its structural formula is: Baclofen is a white to off-white, odorless or practically odorless crystal...
    Active IngredientBaclofen
    Dosage FormTablet
    Routeoral; Oral
    Strength10mg; 20mg
    Market StatusPrescription
    CompanyWatson Labs; Vintage Pharms; Mylan Pharms; Ivax Sub Teva Pharms; Caraco; Lannett; Usl Pharma; Sun Pharm Inds; Northstar Hlthcare; Prosam Labs; Mylan; Impax Labs

    2 of 6  
    Drug NameGablofen
    PubMed HealthBaclofen
    Drug ClassesAnalgesic, Skeletal Muscle Relaxant, Centrally Acting
    Drug LabelGablofen (baclofen injection) is a muscle relaxant and antispastic. Baclofen's pharmacological class is a gamma-aminobutyric acid (GABA) ergic agonist. Baclofen's chemical name is 4-amino- 3-(4-chlorophenyl) butanoic acid, and its structural for
    Active IngredientBaclofen
    Dosage FormInjectable
    RouteIntrathecal
    Strength2mg/ml; 1mg/ml; 0.05mg/ml; 0.5mg/ml
    Market StatusPrescription
    CompanyMallinckrodt

    3 of 6  
    Drug NameLioresal
    PubMed HealthBaclofen (By mouth)
    Drug ClassesSkeletal Muscle Relaxant, Centrally Acting
    Drug LabelLIORESAL INTRATHECAL (baclofen injection) is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid, and its structural formula is: Baclofen is a white to off-white, odorless or practically odorless crystal...
    Active IngredientBaclofen
    Dosage FormInjectable
    RouteIntrathecal
    Strength2mg/ml; 0.05mg/ml; 0.5mg/ml
    Market StatusPrescription
    CompanyMedtronic Neuro

    4 of 6  
    Drug NameBaclofen
    PubMed HealthBaclofen
    Drug ClassesAnalgesic, Skeletal Muscle Relaxant, Centrally Acting
    Drug LabelLIORESAL INTRATHECAL (baclofen injection) is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid, and its structural formula is: Baclofen is a white to off-white, odorless or practically odorless crystal...
    Active IngredientBaclofen
    Dosage FormTablet
    Routeoral; Oral
    Strength10mg; 20mg
    Market StatusPrescription
    CompanyWatson Labs; Vintage Pharms; Mylan Pharms; Ivax Sub Teva Pharms; Caraco; Lannett; Usl Pharma; Sun Pharm Inds; Northstar Hlthcare; Prosam Labs; Mylan; Impax Labs

    5 of 6  
    Drug NameGablofen
    PubMed HealthBaclofen
    Drug ClassesAnalgesic, Skeletal Muscle Relaxant, Centrally Acting
    Drug LabelGablofen (baclofen injection) is a muscle relaxant and antispastic. Baclofen's pharmacological class is a gamma-aminobutyric acid (GABA) ergic agonist. Baclofen's chemical name is 4-amino- 3-(4-chlorophenyl) butanoic acid, and its structural for
    Active IngredientBaclofen
    Dosage FormInjectable
    RouteIntrathecal
    Strength2mg/ml; 1mg/ml; 0.05mg/ml; 0.5mg/ml
    Market StatusPrescription
    CompanyMallinckrodt

    6 of 6  
    Drug NameLioresal
    PubMed HealthBaclofen (By mouth)
    Drug ClassesSkeletal Muscle Relaxant, Centrally Acting
    Drug LabelLIORESAL INTRATHECAL (baclofen injection) is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid, and its structural formula is: Baclofen is a white to off-white, odorless or practically odorless crystal...
    Active IngredientBaclofen
    Dosage FormInjectable
    RouteIntrathecal
    Strength2mg/ml; 0.05mg/ml; 0.5mg/ml
    Market StatusPrescription
    CompanyMedtronic Neuro

    4.2 Drug Indication

    Baclofen is indicated for the treatment of spasticity resulting from multiple sclerosis and is particularly useful for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. It may also be of value in the treatment of patients with spinal cord injuries or diseases. Baclofen is also indicated as an intrathecal injection for the management of severe spasticity of cerebral or spinal original in patients 4 years of age and older. Patients who respond to bolus intrathecal doses of baclofen, and who require chronic therapy, can use an implantable intrathecal pump to administer baclofen via long-term infusion.

    FDA Label

    Treatment of alcohol dependence

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    In neurological diseases associated with spasm of the skeletal muscles, the clinical effects of baclofen occur due to baclofen action on reflex muscle contractions and of significant relief from painful spasm, automatism, as well as clonus. Baclofen, when used as indicated, improves mobility, increasing levels of independence, and facilitates both passive and active physiotherapy. Baclofen also stimulates gastric acid secretion. GABA-B receptor activation by baclofen may produce protective neurological effects. Baclofen also possesses anti-inflammatory properties that may be of interest in the study of addiction treatment. Preclinical studies have shown that GABA-B receptors have roles in memory storage and retrieval, reward, motivation, mood, as well as anxiety. Neuroimaging studies in humans indicate that baclofen produces region-specific alterations in brain activity.

    5.2 MeSH Pharmacological Classification

    GABA-B Receptor Agonists

    Endogenous compounds and drugs that bind to and activate GABA-B RECEPTORS. (See all compounds classified as GABA-B Receptor Agonists.)

    Muscle Relaxants, Central

    A heterogeneous group of drugs used to produce muscle relaxation, excepting the neuromuscular blocking agents. They have their primary clinical and therapeutic uses in the treatment of muscle spasm and immobility associated with strains, sprains, and injuries of the back and, to a lesser degree, injuries to the neck. They have been used also for the treatment of a variety of clinical conditions that have in common only the presence of skeletal muscle hyperactivity, for example, the muscle spasms that can occur in MULTIPLE SCLEROSIS. (From Smith and Reynard, Textbook of Pharmacology, 1991, p358) (See all compounds classified as Muscle Relaxants, Central.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    BACLOFEN
    5.3.2 FDA UNII
    H789N3FKE8
    5.3.3 Pharmacological Classes
    GABA B Agonists [MoA]; gamma-Aminobutyric Acid-ergic Agonist [EPC]; GABA A Agonists [MoA]
    5.4 ATC Code

    M03BX01

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    M - Musculo-skeletal system

    M03 - Muscle relaxants

    M03B - Muscle relaxants, centrally acting agents

    M03BX - Other centrally acting agents

    M03BX01 - Baclofen

    5.5 Absorption, Distribution and Excretion

    Absorption

    Rapidly and almost completely absorbed from the gastrointestinal tract. Absorption may be dose-dependent, being reduced with increased doses. Baclofen, when introduced directly into the intrathecal space, allows for effective CSF concentrations to be achieved with resulting plasma concentrations 100 times less than concentrations occurring with oral administration,.

    Route of Elimination

    Baclofen is rapidly and extensively eliminated from the body. There is significant intersubject variation in elimination rates. Baclofen is excreted mainly by the kidney as unchanged drug. Seventy to eighty (70 - 80%) of a dose is measured in the urine as unchanged drug. The remainder of the dose is excreted as unchanged drug in the feces or as metabolites in the urine and feces. Excretion is complete within 72 hours after administration.

    Volume of Distribution

    **Apparent volume of distribution**: 59 liters. Baclofen does not readily cross the blood-brain barrier.

    Clearance

    **Total systemic clearance**: 180 mL/min **Renal clearance**: 103 mL/min Baclofen is primarily excreted unchanged by the kidneys. It should be administered cautiously, and it may be necessary to reduce the dosage in patients with reduced renal function.

    5.6 Metabolism/Metabolites

    Approximately 15% of the dose is metabolized in the liver, mainly by deamination. In a clinical study with radiolabeled baclofen, approximately 85% of the dose was excreted unchanged in the urine and feces. The -hydroxy metabolite, 3-(p-chlorophenyl)-4-hydroxybutyric acid, is formed by the deamination of baclofen. Because baclofen is partially metabolized in the liver, patients with impaired liver function should be regularly monitored with liver function tests.

    5.7 Biological Half-Life

    Elimination half-life: Approximately 5.5 hours.

    5.8 Mechanism of Action

    The exact mechanism of action of baclofen is not fully understood at this time,. Many studies indicate that baclofen is a GABA-B receptor agonist,,,,. Despite this, there is no conclusive evidence that the effects of baclofen on GABA systems are involved in the production of its clinical effects. Baclofen is an effective and widely used antispastic agent with a spinal site of action. Its mechanism of action and pharmacological properties are different from the effects of other antispastic agents. In addition, baclofen has central sites of action, shown by its adverse event profile and general CNS depressant properties. GABA-B receptors interact with signal transduction pathways and neurotransmitter systems. Baclofen exerts an antinociceptive effect. The clinical significance of this warrants further research data for clarification. Baclofen depresses monosynaptic and polysynaptic reflex transmission, by various actions, and possibly including the stimulation of GABA-receptors. This stimulation results in the inhibition of excitatory neurotransmitter (glutamate and aspartate) release, which may normally contribute to pain and spasticity. Although baclofen is an analog of the inhibitory neurotransmitter gamma-amino-butyric acid (GABA), there are no conclusive data indicating GABA systems are involved in its clinical effects.

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    01

    Polpharma

    Poland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-08

    Pay. Date : 2012-12-11

    DMF Number : 18014

    Submission : 2005-01-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2010-316 - Rev 06

    Issue Date : 2024-10-04

    Type : Chemical

    Substance Number : 653

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10014

    Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND

    Initial Date of Registration : 2018-01-30

    Latest Date of Registration : --

     EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12658-0448

    Start Marketing Date : 1977-11-22

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

     KDMF arrow-down
    ✖

    Registrant Name : Wooshin Labotech Co., Ltd.

    Registration Date : 2019-08-02

    Registration Number : 20181018-209-J-161(5)

    Manufacturer Name : Pharmaceutical Works Polpharma S.A.

    Manufacturer Address : 19, Pelplinska Street. 83-200 Starogard Gdanski, Poland

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    Available Reg Filing : ASMF, CA
    AUDIT
    Polpharma CB

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    02

    LGM Pharma

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Virtual Booth Virtual Booth
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    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    LGM Pharma CB

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    03

    Aspen API

    Netherlands

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI India 2024
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAspen API. More than just an API.

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    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 6421

    Submission : 1986-06-18

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Aspen API Comapny Banner

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    Product Web Link

    Virtual Booth

    Digital Content

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    04

    Seqens

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-10-04

    Pay. Date : 2013-09-30

    DMF Number : 7077

    Submission : 1987-07-14

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-247 - Rev 01

    Issue Date : 2020-07-30

    Type : Chemical

    Substance Number : 653

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51014-7035

    Start Marketing Date : 2009-08-17

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF BR, CA arrow-down
    ✖
    Available Reg Filing : BR, CA
    AUDIT
    Seqens Company Banner

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    05

    Cohance Lifesciences

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI India 2024
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-12-29

    Pay. Date : 2018-11-26

    DMF Number : 33302

    Submission : 2018-11-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2018-280 - Rev 01

    Issue Date : 2022-12-15

    Type : Chemical

    Substance Number : 653

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-07

    Valid Till : 2025-07-21

    Written Confirmation Number : WC-0150

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2021-06-29

    Registration Number : 20210629-209-J-1043

    Manufacturer Name : Cohance Lifesciences Limited

    Manufacturer Address : RS 50/1, Mukteswarapuram Village, Jaggaiahpeta Mandal, Krishna District-521 175. Andhra Pradesh, India

     VMF Others AUDIT
    Cohance

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    06

    Fareva

    Luxembourg

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothFareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-23

    Pay. Date : 2013-07-10

    DMF Number : 7311

    Submission : 1988-02-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2007-238 - Rev 04

    Issue Date : 2024-01-11

    Type : Chemical

    Substance Number : 653

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 220MF10253

    Registrant's Address : NUERNBERGER STRASSE 12, 90537 FEUCHT, GERMANY

    Initial Date of Registration : 2008-12-12

    Latest Date of Registration : --

     EU-WC NDC arrow-down
    ✖

    NDC Package Code : 46014-1014

    Start Marketing Date : 2008-05-05

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF ASMF arrow-down
    ✖
    Available Reg Filing : ASMF
    AUDIT
    Fareva Company Banner

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    07

    Jai Radhe Sales

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI India 2024
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Jai Radhe Sales

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    08

    HRV Global Life Sciences

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI India 2024
    Booth #2.D38
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
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    Available Reg Filing : AU
    AUDIT
    HRV Global Life Sciences

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    Digital Content

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    09

    Octavius Pharma Pvt. Ltd

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI India 2024
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Octavius Pharma

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    10

    Bal Pharma

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI India 2024
    Booth #5.I21
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothBal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

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    Virtual Booth Virtual Booth
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    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    BalPharma

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    USDMF

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    01

    Zaklady Farmaceutyczne Polpharma Sa

    Poland
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Contact Supplier Contact Supplier
    Flag Poland
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-01-08

    Pay. Date : 2012-12-11

    DMF Number : 18014

    Submission : 2005-01-20

    Status : Active

    Type : II

    Polpharma CB

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    02

    Fine Chemicals Corp Pty Ltd

    Netherlands
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAspen API. More than just an API.

    Contact Supplier Contact Supplier
    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 6421

    Submission : 1986-06-18

    Status : Active

    Type : II

    Aspen API Comapny Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    03

    Fine Chemicals Corp Pty Ltd

    Netherlands
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAspen API. More than just an API.

    Contact Supplier Contact Supplier
    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35224

    Submission : 2020-10-16

    Status : Active

    Type : II

    Aspen API Comapny Banner

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    Product Web Link

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    04

    Fine Chemicals Corp Pty Ltd

    Netherlands
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAspen API. More than just an API.

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    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12541

    Submission : 1997-04-17

    Status : Active

    Type : IV

    Aspen API Comapny Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

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    05

    Pcas

    France
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-10-04

    Pay. Date : 2013-09-30

    DMF Number : 7077

    Submission : 1987-07-14

    Status : Active

    Type : II

    Seqens Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    06

    Cohance Lifesciences Ltd

    India
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : Complete

    Rev. Date : 2018-12-29

    Pay. Date : 2018-11-26

    DMF Number : 33302

    Submission : 2018-11-09

    Status : Active

    Type : II

    Cohance

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

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    07

    Erregierre Spa

    Italy

    USDMF

    arrow
    Antibody Engineering
    Not Confirmed

    07

    Erregierre Spa

    Italy
    arrow
    Antibody Engineering
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 7817

    Submission : 1988-12-15

    Status : Inactive

    Type : II

    blank

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    08

    Excella Gmbh And Co Kg

    Luxembourg

    USDMF

    arrow
    Antibody Engineering
    Not Confirmed

    08

    Excella Gmbh And Co Kg

    Luxembourg
    arrow
    Antibody Engineering
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-07-23

    Pay. Date : 2013-07-10

    DMF Number : 7311

    Submission : 1988-02-02

    Status : Active

    Type : II

    blank

    Portfolio PDF

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    Virtual Booth

    Digital Content

    Website

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    09

    Icfi Spa

    Italy

    USDMF

    arrow
    Antibody Engineering
    Not Confirmed

    09

    Icfi Spa

    Italy
    arrow
    Antibody Engineering
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 7499

    Submission : 1988-05-26

    Status : Inactive

    Type : II

    blank

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    10

    Resolution Chemicals Ltd

    United Kingdom

    USDMF

    arrow
    Antibody Engineering
    Not Confirmed

    10

    Resolution Chemicals Ltd

    United Kingdom
    arrow
    Antibody Engineering
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 7368

    Submission : 1988-03-08

    Status : Inactive

    Type : II

    blank

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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"BACLOFEN","year":"2021","qtr":"Q1","strtotime":1610649000,"product":"BACLOFEN IP (PHARMACEUTICAL RAW MATERIAL )","address":"5TH FLOOR,LAXMI NARAYAN COMPLEX,10\/1 PALACE ROAD,","city":"BANGALORE","supplier":"BAL PHARMA","supplierCountry":"INDIA","foreign_port":"BHAIRAWA","customer":"ASIAN PHARMACEUTICALS PVT LTD","customerCountry":"NEPAL","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"243.1","totalValueFC":"492.2","currency":"USD","unitRateINR":18000,"date":"15-Jan-2021","totalValueINR":"36000","totalValueInUsd":"492.2","indian_port":"SONAULI","hs_no":"29224990","bill_no":"7929858","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"NEPAL","selfForZScoreResived":"Pharma Grade","supplierPort":"SONAULI","supplierAddress":"5TH FLOOR,LAXMI NARAYAN COMPLEX,10\/1 PALACE ROAD,, BANGALORE","customerAddress":""},{"dataSource":"API Export","activeIngredients":"BACLOFEN","year":"2021","qtr":"Q1","strtotime":1611081000,"product":"BACLOFEN USP","address":"309 HARIKRUPA TOWER NR.OLD-SHARDA MANDIR CHAR RASTA ELLISBRIDG","city":"AHMEDABAD","supplier":"JAI RADHE SALES","supplierCountry":"INDIA","foreign_port":"SANTIAGO","customer":"RT S.A","customerCountry":"CHILE","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"149.8","totalValueFC":"1517","currency":"USD","unitRateINR":11095.113000000001,"date":"20-Jan-2021","totalValueINR":"110951.13","totalValueInUsd":"1517","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"8021627","productDescription":"API","marketType":"REGULATED MARKET","country":"CHILE","selfForZScoreResived":"Pharma Grade","supplierPort":"AHMEDABAD AIR","supplierAddress":"309 HARIKRUPA TOWER NR.OLD-SHARDA MANDIR CHAR RASTA ELLISBRIDG, AHMEDABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"BACLOFEN","year":"2021","qtr":"Q1","strtotime":1611081000,"product":"BACLOFEN BP","address":"1,MASTER CHAMBER,1ST CINEMA ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"PANCHSHEEL ORGANIC LTD.","supplierCountry":"INDIA","foreign_port":"ISLAMABAD - ISLAMABA","customer":"NAVEGAL LABORATORIES","customerCountry":"PAKISTAN","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"175","totalValueFC":"752","currency":"USD","unitRateINR":11000,"date":"20-Jan-2021","totalValueINR":"55000","totalValueInUsd":"752","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"8043353","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"1,MASTER CHAMBER,1ST CINEMA ROAD,, MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"BACLOFEN","year":"2021","qtr":"Q1","strtotime":1611685800,"product":"BACLOFEN BP","address":"1,MASTER CHAMBER,1ST CINEMA ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"PANCHSHEEL ORGANIC LTD.","supplierCountry":"INDIA","foreign_port":"ISLAMABAD - ISLAMABA","customer":"NAVEGAL LABORATORIES","customerCountry":"PAKISTAN","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"175","totalValueFC":"752","currency":"USD","unitRateINR":11000,"date":"27-Jan-2021","totalValueINR":"55000","totalValueInUsd":"752","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"8196034","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"1,MASTER CHAMBER,1ST CINEMA ROAD,, MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"BACLOFEN","year":"2021","qtr":"Q1","strtotime":1611945000,"product":"BACLOFEN IP","address":"70, PRINCESS STREET, RANVIR BUILDING, 2ND FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"PREMIER DRUG HOUSE","supplierCountry":"INDIA","foreign_port":"KATHMANDU","customer":"NOVA GENETICA P ","customerCountry":"NEPAL","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"9500","totalValueFC":"656.3","currency":"INR","unitRateINR":9600,"date":"30-Jan-2021","totalValueINR":"48000","totalValueInUsd":"656.3","indian_port":"RAXAUL","hs_no":"29420090","bill_no":"8268124","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"NEPAL","selfForZScoreResived":"Pharma Grade","supplierPort":"RAXAUL","supplierAddress":"70, PRINCESS STREET, RANVIR BUILDING, 2ND FLOOR,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"BACLOFEN","year":"2021","qtr":"Q1","strtotime":1613327400,"product":"BACLOFEN BP","address":"1,MASTER CHAMBER,1ST CINEMA ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"PANCHSHEEL ORGANIC LTD.","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"SILCO PHARMACEUTICALS LIMITED 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PELPLINSKA 19;, POLAND","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722450600,"product":"BACLOFEN BATCH NO. BA202400065","address":"CADILA CORPORATE CAMPUS","city":"AHMEDABAD, GUJARAT","supplier":"BIOINDUSTRIA L.I.M. SPA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"CADILA PHARMACEUTICALS","customerCountry":"INDIA","quantity":"11.00","actualQuantity":"11","unit":"KGS","unitRateFc":"850","totalValueFC":"10333.3","currency":"EUR","unitRateINR":"78795","date":"01-Aug-2024","totalValueINR":"866745","totalValueInUsd":"10333.3","indian_port":"Ahmedabad Air","hs_no":"29224990","bill_no":"4816796","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"15067 NOVI LIGURE (AL) VIA DE ABROSIS 2 , , ItalySDNF Italy","customerAddress":"CADILA CORPORATE CAMPUS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722450600,"product":"BACLOFEN USP","address":"221, GOREGAON-MULUND LINK ROAD,","city":"BHANDUP WEST, MUMBAI","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"RUBICON RESEARCH","customerCountry":"INDIA","quantity":"87.40","actualQuantity":"87.4","unit":"KGS","unitRateFc":"365","totalValueFC":"32156.4","currency":"USD","unitRateINR":"30860.8","date":"01-Aug-2024","totalValueINR":"2697229.55","totalValueInUsd":"32156.4","indian_port":"Bombay Air","hs_no":"29224990","bill_no":"4820871","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WARSAW","supplierAddress":"83-200 STAROGARD GDANSKIUL. PELPLINSKA 19POLAND PL","customerAddress":"221, GOREGAON-MULUND LINK ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724697000,"product":"BACLOFEN (QTY:200 KGS)ASPER INV","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"WARSZAWA, MZ","customer":"MS APL HEALTH ","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"290","totalValueFC":"58671.7","currency":"USD","unitRateINR":"24606.5","date":"27-Aug-2024","totalValueINR":"4921300","totalValueInUsd":"58671.7","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29224990","bill_no":"1002714","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WARSZAWA, MZ","supplierAddress":"83-200 STAROGARD GSANSKI UL PELPLIN SKA 19 POLAND","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"}]
    15-Jan-2021
    28-Oct-2024
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

    API Imports and Exports

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    Drugs in Development

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    ANI Pharmaceuticals Announces the Launch of Baclofen Oral Suspension

    Details:

    ANI will commercialize generic Fleqsuvy (baclofen) to treat spasticity from multiple sclerosis, offering relief from flexor spasms and pain, with significant therapeutic benefits.


    Lead Product(s): Baclofen

    Therapeutic Area: Neurology Brand Name: Fleqsuvy-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 09, 2024

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    01

    ANI Pharmaceuticals Inc

    U.S.A
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    Lead Product(s) : Baclofen

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    ANI Pharmaceuticals Announces the Launch of Baclofen Oral Suspension

    Details : ANI will commercialize generic Fleqsuvy (baclofen) to treat spasticity from multiple sclerosis, offering relief from flexor spasms and pain, with significant therapeutic benefits.

    Brand Name : Fleqsuvy-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    April 09, 2024

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    Nexus Pharmaceuticals Launches Baclofen Injection, USP

    Details:

    Baclofen is a GABA-ergic agonist. It is indicated for treatment of patients with multiple sclerosis, cerebral palsy, spinal cord injuries, and other conditions that result in muscle spasms.


    Lead Product(s): Baclofen

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 18, 2024

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    02

    Nexus Pharmaceuticals

    U.S.A
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    Lead Product(s) : Baclofen

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Nexus Pharmaceuticals Launches Baclofen Injection, USP

    Details : Baclofen is a GABA-ergic agonist. It is indicated for treatment of patients with multiple sclerosis, cerebral palsy, spinal cord injuries, and other conditions that result in muscle spasms.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    March 18, 2024

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    Allos Pharma Inc. Receives FDA Guidance for the Design of a Phase 3 Trial to Support a New Drug Application for Treatment of Fragile X Syndrome

    Details:

    Arbaclofen selectively activates GABA-B receptors to decrease presynaptic release of excitatory neurotransmitters while simultaneously decreasing excitability of the postsynaptic neuron.


    Lead Product(s): Baclofen

    Therapeutic Area: Genetic Disease Brand Name: STX209

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 23, 2023

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    03

    Allos Pharma

    U.S.A
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    Lead Product(s) : Baclofen

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Allos Pharma Inc. Receives FDA Guidance for the Design of a Phase 3 Trial to Support a New Drug Ap...

    Details : Arbaclofen selectively activates GABA-B receptors to decrease presynaptic release of excitatory neurotransmitters while simultaneously decreasing excitability of the postsynaptic neuron.

    Brand Name : STX209

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    May 23, 2023

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    Pharnext Executes a Financing Agreement with Néovacs for EUR 20.7 Million Net to Further Develop PXT3003 for Charcot-Marie-Tooth Disease Type 1A

    Details:

    The financing by Neovacs will support Pharnext operations and cash requirements, in particular the Phase III PREMIER pivotal study assessing its PTX3003 (baclofen) candidate in CMT1A, a rare debilitating peripheral neuropathy with currently no existing approved therapy.


    Lead Product(s): Baclofen,Naltrexone,Sorbitol API

    Therapeutic Area: Genetic Disease Brand Name: PTX3003

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Neovacs

    Deal Size: $20.0 million Upfront Cash: Undisclosed

    Deal Type: Financing October 03, 2022

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    Pharnext

    France
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    Lead Product(s) : Baclofen,Naltrexone,Sorbitol API

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Neovacs

    Deal Size : $20.0 million

    Deal Type : Financing

    DEALS_DEV arrow-down

    Pharnext Executes a Financing Agreement with Néovacs for EUR 20.7 Million Net to Further Develop ...

    Details : The financing by Neovacs will support Pharnext operations and cash requirements, in particular the Phase III PREMIER pivotal study assessing its PTX3003 (baclofen) candidate in CMT1A, a rare debilitating peripheral neuropathy with currently no existing a...

    Brand Name : PTX3003

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    October 03, 2022

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    Pharnext: Findings From 'Real-World' Digital Lifestyle Study, CMT&Me, on Symptom Burden of Charcot-Marie-Tooth Disease Type 1A Published in the Journal ...

    Details:

    PXT3003 (baclofen) completed an international Phase III trial with positive topline results for the treatment of CharcotMarie-Tooth disease type 1A (‘CMT1A’) and benefits from orphan drug status in Europe and the United States.


    Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API

    Therapeutic Area: Genetic Disease Brand Name: PXT3003

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 13, 2022

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    Pharnext

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    Lead Product(s) : Baclofen,Naltrexone Hydrochloride,Sorbitol API

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Pharnext: Findings From 'Real-World' Digital Lifestyle Study, CMT&Me, on Symptom Burden of Charcot...

    Details : PXT3003 (baclofen) completed an international Phase III trial with positive topline results for the treatment of CharcotMarie-Tooth disease type 1A (‘CMT1A’) and benefits from orphan drug status in Europe and the United States.

    Brand Name : PXT3003

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 13, 2022

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    Pharnext Announces First Patient Enrolled in Open Label Extension of the Pivotal Phase III Study of PXT3003 for the Treatment of Charcot-Marie-Tooth Dis...

    Details:

    PXT3003 (baclofen) is a novel fixed-dose synergistic combination of baclofen, naltrexone and sorbitol formulated as an oral solution given twice a day for the treatment of Charcot-Marie-Tooth disease type 1A.


    Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API

    Therapeutic Area: Genetic Disease Brand Name: PXT3003

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 12, 2022

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    Pharnext

    France
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    Lead Product(s) : Baclofen,Naltrexone Hydrochloride,Sorbitol API

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Pharnext Announces First Patient Enrolled in Open Label Extension of the Pivotal Phase III Study o...

    Details : PXT3003 (baclofen) is a novel fixed-dose synergistic combination of baclofen, naltrexone and sorbitol formulated as an oral solution given twice a day for the treatment of Charcot-Marie-Tooth disease type 1A.

    Brand Name : PXT3003

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 12, 2022

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    Allos Pharma Inc. Presents New Positive Data Analyses at the 18th NFXF International Fragile X Conference

    Details:

    Clinically meaningful magnitudes of improvement were observed on all three ABCFX subscales for 45% of individuals receiving high dose of arbaclofen vs 4% treated with placebo (P=0.00003), clearly demonstrating efficacy of STX209 (arbaclofen) in individuals with Fragile X.


    Lead Product(s): Baclofen

    Therapeutic Area: Genetic Disease Brand Name: STX209

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 14, 2022

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    Allos Pharma

    U.S.A
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    Lead Product(s) : Baclofen

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Allos Pharma Inc. Presents New Positive Data Analyses at the 18th NFXF International Fragile X Con...

    Details : Clinically meaningful magnitudes of improvement were observed on all three ABCFX subscales for 45% of individuals receiving high dose of arbaclofen vs 4% treated with placebo (P=0.00003), clearly demonstrating efficacy of STX209 (arbaclofen) in individua...

    Brand Name : STX209

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 14, 2022

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    Amneal Launches LYVISPAH® (baclofen) for Spasticity Related to Multiple Sclerosis and Other Spinal Cord Disorders

    Details:

    LYVISPAH is bioequivalent to oral baclofen tablets and provides flexible, a skeletal muscle relaxant, is well established for the treatment of spasticity and spinal cord injuries.


    Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API

    Therapeutic Area: Musculoskeletal Brand Name: Lyvispah

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 01, 2022

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    Amneal Pharmaceuticals

    U.S.A
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    Lead Product(s) : Baclofen,Naltrexone Hydrochloride,Sorbitol API

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Amneal Launches LYVISPAH® (baclofen) for Spasticity Related to Multiple Sclerosis and Other Spina...

    Details : LYVISPAH is bioequivalent to oral baclofen tablets and provides flexible, a skeletal muscle relaxant, is well established for the treatment of spasticity and spinal cord injuries.

    Brand Name : Lyvispah

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    June 01, 2022

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    New Data from the Open-Label PLEO-CMT-FU Trial Shows Sustained Benefit with PXT3003 in Patients with Charcot-Marie-Tooth Disease Type 1A After 5 Years o...

    Details:

    New data from the ongoing Open-Label Phase III Extension Study of PXT3003 (baclofen), the PLEO-CMT-FU trial, suggest good safety profile and continuous treatment effect of PXT3003 measured on the Overall Neuropathy Limitation Scale after 5 years of total trial time.


    Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API

    Therapeutic Area: Genetic Disease Brand Name: PXT3003

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 16, 2022

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    09

    Pharnext

    France
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    Lead Product(s) : Baclofen,Naltrexone Hydrochloride,Sorbitol API

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    New Data from the Open-Label PLEO-CMT-FU Trial Shows Sustained Benefit with PXT3003 in Patients wi...

    Details : New data from the ongoing Open-Label Phase III Extension Study of PXT3003 (baclofen), the PLEO-CMT-FU trial, suggest good safety profile and continuous treatment effect of PXT3003 measured on the Overall Neuropathy Limitation Scale after 5 years of total...

    Brand Name : PXT3003

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    May 16, 2022

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    Amneal Acquires Saol Therapeutics’ Baclofen Franchise

    Details:

    Amneal is adding Saol’s experienced institutional commercial team for Lioresal that can be utilized to support product launches, including biosimilar products, filgrastim (biosimilar for Neupogen), pegfilgrastim (biosimilar for Neulasta) & bevacizumab (biosimilar for Avastin).


    Lead Product(s): Baclofen

    Therapeutic Area: Musculoskeletal Brand Name: Lioresal

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Amneal Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Acquisition January 05, 2022

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    10

    Saol therapeutics

    U.S.A
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    Saol therapeutics

    U.S.A
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    Lead Product(s) : Baclofen

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Amneal Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Amneal Acquires Saol Therapeutics’ Baclofen Franchise

    Details : Amneal is adding Saol’s experienced institutional commercial team for Lioresal that can be utilized to support product launches, including biosimilar products, filgrastim (biosimilar for Neupogen), pegfilgrastim (biosimilar for Neulasta) & bevacizumab ...

    Brand Name : Lioresal

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    January 05, 2022

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    INTERMEDIATES SUPPLIERS

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    01

    Faran Shimi Pharmaceutical

    Iran
    Medlab Asia & Asia Health
    Not Confirmed
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    Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

    3-(4-Chlorophenyl)Glutaric Acid Monoamide

    CAS Number : 1141-23-7

    End Use API : Baclofen

    About The Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutica...

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    Dishman Carbogen Amcis

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Dishman Carbogen Amcis

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    3-(4-chlorophenyl glutaric acid)

    CAS Number : 35271-74-0

    End Use API : Baclofen

    About The Company : We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bri...

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    LifeFirst Pharma

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    LifeFirst Pharma

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    3-(4-chlorophenylglutaranic acid

    CAS Number : 1141-23-7

    End Use API : Baclofen

    About The Company : We believe in attaining the highest levels of customer satisfaction and social welfare with the philosophy of keeping first things first. Our systematic interve...

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    LifeFirst Pharma

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    LifeFirst Pharma

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    3-(4-Chlorophenyl)pentanedioic acid

    CAS Number : 35271-74-0

    End Use API : Baclofen

    About The Company : We believe in attaining the highest levels of customer satisfaction and social welfare with the philosophy of keeping first things first. Our systematic interve...

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    05

    Meck Pharma

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Meck Pharma

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    3-(4-Chlorophenyl) Glutaric Acid

    CAS Number : 35271-74-0

    End Use API : Baclofen

    About The Company : Meck Pharmaceuticals and Chemicals Pvt. Ltd. is a leading manufacturer of Pharmaceutical Bulk Drugs, API's, Intermediates, Nutraceuticals, and Specialty Chemica...

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    06

    Medilux Laboratories

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Medilux Laboratories

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    3-(4-Chlorophenyl)glutaric acid

    CAS Number : 35271-74-0

    End Use API : Baclofen

    About The Company : Medilux Laboratories has been providing quality back-end support to the pharmaceutical industry since our inception in 1988. Our resources are dedicated to prom...

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    Medilux Laboratories

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Medilux Laboratories

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    3-(4-Chlorophenyl)glutaric anhydride

    CAS Number : 53911-68-5

    End Use API : Baclofen

    About The Company : Medilux Laboratories has been providing quality back-end support to the pharmaceutical industry since our inception in 1988. Our resources are dedicated to prom...

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    08

    Medilux Laboratories

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Medilux Laboratories

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    3-(4-Chlorophenyl)glutarimide

    CAS Number : 84803-46-3

    End Use API : Baclofen

    About The Company : Medilux Laboratories has been providing quality back-end support to the pharmaceutical industry since our inception in 1988. Our resources are dedicated to prom...

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    09

    Medilux Laboratories

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Medilux Laboratories

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    • EDQM
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    3-(4-Chlorophenyl)glutaric acid monoamide

    CAS Number : 1141-23-7

    End Use API : Baclofen

    About The Company : Medilux Laboratories has been providing quality back-end support to the pharmaceutical industry since our inception in 1988. Our resources are dedicated to prom...

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    10

    Pluviaendo

    Turkey
    Medlab Asia & Asia Health
    Not Confirmed
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    Pluviaendo

    Turkey
    Medlab Asia & Asia Health
    Not Confirmed
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    3-(4-Chlorophenyl) glutaric acid monoamide

    CAS Number : 1141-23-7

    End Use API : Baclofen

    About The Company : Pluvia Consumer Health is a multinational pharmaceutical company with its head office in Turkey/Istanbul & with unique molecules & know-how. Our portfolio conta...

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    Europe

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    01

    BIOINDUSTRIA L.I.M. SpA

    Italy
    Antibody Engineering
    Not Confirmed
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    BIOINDUSTRIA L.I.M. SpA

    Italy
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    Regulatory Info :

    Registration Country : Italy

    Baclofen

    Brand Name : Baclofen

    Dosage Form : Baclofen 0.05Mg 1Ml 10 Units Intrathecal Use

    Dosage Strength : 10 vials injector soluz 0.05 mg 1 ml intrathecal use

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    02

    Bluefish Pharmaceuticals AB

    Sweden
    Antibody Engineering
    Not Confirmed
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    Bluefish Pharmaceuticals AB

    Sweden
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    Flag Sweden
    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Sweden

    baclofen

    Brand Name : Baclofen Bluefish

    Dosage Form : TABLET

    Dosage Strength : 10 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    03

    Labatec Pharma SA

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Labatec Pharma SA

    Switzerland
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    Flag Switzerland
    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Switzerland

    Baclofenum

    Brand Name : Baclocalm

    Dosage Form : Tabl

    Dosage Strength : 10mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    04

    Mallinckrodt Deutschland GmbH

    Ireland
    Antibody Engineering
    Not Confirmed
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    Mallinckrodt Deutschland GmbH

    Ireland
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    Flag Ireland
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Sweden

    baclofen

    Brand Name : Gablofen

    Dosage Form : INJECTION / INFUSION

    Dosage Strength : 0.5 MG / ML

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    05

    MOLTENI & C. F.LLI ALITTI SpA

    Italy
    Antibody Engineering
    Not Confirmed
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    MOLTENI & C. F.LLI ALITTI SpA

    Italy
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    Regulatory Info :

    Registration Country : Italy

    Baclofen

    Brand Name : Baclofen

    Dosage Form : Baclofen 10Mg 5Ml 10 Units Intrathecal Use

    Dosage Strength : 10 vials injector soluz intrathecal 10 mg 5 ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    06

    Novartis Pharma Schweiz AG

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Novartis Pharma Schweiz AG

    Switzerland
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    Flag Switzerland
    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Switzerland

    Baclofenum

    Brand Name : Lioresal

    Dosage Form : Tablet

    Dosage Strength : 10mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    07

    Orifarm AB

    Denmark
    Antibody Engineering
    Not Confirmed
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    Orifarm AB

    Denmark
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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Sweden

    baclofen

    Brand Name : Lioresal

    Dosage Form : INJECTION / INFUSION

    Dosage Strength : 2 MG / ML

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    08

    SUN PHARMACEUTICAL IND.EU.B.V.

    India
    Antibody Engineering
    Not Confirmed
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    SUN PHARMACEUTICAL IND.EU.B.V.

    India
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    Regulatory Info :

    Registration Country : Italy

    Baclofen

    Brand Name : Baclofen

    Dosage Form : Baclofen 0.05Mg 1Ml 1 Units Use Intrathecal

    Dosage Strength : 1 ampoule 0.05 mg/1 ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    09

    Mylan AB

    U.S.A
    Antibody Engineering
    Not Confirmed
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    U.S.A
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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Sweden

    baclofen

    Brand Name : Baclofen Mylan

    Dosage Form : TABLET

    Dosage Strength : 25 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    10

    Alter Nova

    Country
    Antibody Engineering
    Not Confirmed
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    Alter Nova

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    Regulatory Info :

    Registration Country : Norway

    Baclofen

    Brand Name : Lionova

    Dosage Form : Injection/infusion fluid, resolution

    Dosage Strength : 0.5 mg/ml

    Packaging : Ampoule

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - SOLUTION;ORAL - 10MG/5ML

    USFDA APPLICATION NUMBER - 208193

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    DOSAGE - SOLUTION;ORAL - 5MG/5ML

    USFDA APPLICATION NUMBER - 208193

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    DOSAGE - INJECTABLE;INTRATHECAL - 0.05MG/ML

    USFDA APPLICATION NUMBER - 22462

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    DOSAGE - INJECTABLE;INTRATHECAL - 0.5MG/ML

    USFDA APPLICATION NUMBER - 22462

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    DOSAGE - INJECTABLE;INTRATHECAL - 1MG/ML

    USFDA APPLICATION NUMBER - 22462

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    DOSAGE - INJECTABLE;INTRATHECAL - 2MG/ML

    USFDA APPLICATION NUMBER - 22462

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