menu
    • menu

    Find Pregabalin manufacturers, exporters & distributors on PharmaCompass

    NEW Prospects: 43
    Pregabalin

    Virtual Booth

    Contact Supplier

    Pregabalin

    Virtual Booth

    Contact Supplier

    pharmacompass-1-m-2026-04-20

    Virtual Booth

    Contact Supplier

    Pregabalin

    Virtual Booth

    Contact Supplier

    Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Virtual Booth

    Contact Supplier

    pharmacompass-2-m-2026-04-20

    Virtual Booth

    Contact Supplier

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

    DRUG PRODUCT COMPOSITIONS

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

    MARKET PLACE

    PATENTS & EXCLUSIVITIES

    REF. STANDARDS & IMPURITIES

    ANALYTICAL

    PharmaCompass

    Synopsis

    Product SearchProduct Search

    Chemistry

    Click the arrow to open the dropdown
    read-moreClick the button for full data set
    read-moreClick the button for full data set
    Also known as: 148553-50-8, Lyrica, (s)-3-(aminomethyl)-5-methylhexanoic acid, 3-isobutyl gaba, (3s)-3-(aminomethyl)-5-methylhexanoic acid, Ci-1008
    Molecular Formula
    C8H17NO2
    Molecular Weight
    159.23  g/mol
    InChI Key
    AYXYPKUFHZROOJ-ZETCQYMHSA-N
    FDA UNII
    55JG375S6M
    Pregabalin
    A gamma-aminobutyric acid (GABA) derivative that functions as a CALCIUM CHANNEL BLOCKER and is used as an ANTICONVULSANT as well as an ANTI-ANXIETY AGENT. It is also used as an ANALGESIC in the treatment of NEUROPATHIC PAIN and FIBROMYALGIA.
    1 2D Structure

    Pregabalin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (3S)-3-(aminomethyl)-5-methylhexanoic acid
    2.1.2 InChI
    InChI=1S/C8H17NO2/c1-6(2)3-7(5-9)4-8(10)11/h6-7H,3-5,9H2,1-2H3,(H,10,11)/t7-/m0/s1
    2.1.3 InChI Key
    AYXYPKUFHZROOJ-ZETCQYMHSA-N
    2.1.4 Canonical SMILES
    CC(C)CC(CC(=O)O)CN
    2.1.5 Isomeric SMILES
    CC(C)C[C@@H](CC(=O)O)CN
    2.2 Other Identifiers
    2.2.1 UNII
    55JG375S6M
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (r-)-3-isobutyl Gaba

    2. (s)-3-(aminomethyl)-5-methylhexanoic Acid

    3. (s+)-3-isobutyl Gaba

    4. 1008, Ci

    5. 3 Isobutyl Gaba

    6. 3-(aminomethyl)-5-methylhexanoic Acid

    7. 3-isobutyl Gaba

    8. Ci 1008

    9. Ci-1008

    10. Ci1008

    11. Gaba, 3-isobutyl

    12. Lyrica

    2.3.2 Depositor-Supplied Synonyms

    1. 148553-50-8

    2. Lyrica

    3. (s)-3-(aminomethyl)-5-methylhexanoic Acid

    4. 3-isobutyl Gaba

    5. (3s)-3-(aminomethyl)-5-methylhexanoic Acid

    6. Ci-1008

    7. (s)-pregabalin

    8. Hexanoic Acid, 3-(aminomethyl)-5-methyl-, (3s)-

    9. Vronogabic

    10. Ci 1008

    11. Pregabalin Mylan

    12. Pregabalin Sandoz

    13. Pd 144723

    14. Pd-144723

    15. Pregabalin Zentiva

    16. Pregabalin Sandoz Gmbh

    17. (s)-3-isobutyl Gaba

    18. Chembl1059

    19. Chebi:64356

    20. (3s)-3-(aminomethyl)-5-methyl-hexanoic Acid

    21. 55jg375s6m

    22. Ynp-1807

    23. Nsc-759256

    24. Hexanoic Acid, 3-(aminomethyl)-5-ethyl-, (3s)-

    25. (r-)-3-isobutyl Gaba

    26. Pregabalin [usan]

    27. Hexanoic Acid, 3-(aminomethyl)-5-methyl-, (s)-

    28. Pregabalina

    29. Pregabaline

    30. Nervalin

    31. Pregablin

    32. Unii-55jg375s6m

    33. Hsdb 7530

    34. Pregabalin [usan:inn:ban:jan]

    35. Ncgc00095186-01

    36. Pregabalin- Bio-x

    37. Lyrica (tn)

    38. Mfcd00917044

    39. Lyrica Cr

    40. Pregabalin [mi]

    41. (s)-3-(aminomethyl)-5-methylhexanoicacid

    42. Pregabalin [inn]

    43. Pregabalin [jan]

    44. Pregabalin [hsdb]

    45. Pregabalin [vandf]

    46. Pregabalin [mart.]

    47. Schembl8227

    48. Dsstox_cid_25950

    49. Dsstox_rid_81246

    50. Pregabalin [usp-rs]

    51. Pregabalin [who-dd]

    52. Dsstox_gsid_45950

    53. Pregabalin (jan/usan/inn)

    54. Pregabalin [ema Epar]

    55. Pregabalin Mylan Pharma

    56. (s)-(+)-4-amino-3-(2-methylpropyl)butanoic Acid

    57. Gtpl5484

    58. Zinc5152

    59. Dea No. 2782

    60. Pregabalin, >=97% (nmr)

    61. Dtxsid1045950

    62. Pregabalin [orange Book]

    63. Pregabalin [ep Monograph]

    64. Hms3715j16

    65. Pregabalin [usp Monograph]

    66. Pregabalin 1.0 Mg/ml In Methanol

    67. Tox21_111475

    68. Bdbm50164279

    69. Akos001476611

    70. Akos005145504

    71. Lyrica;ci-1008;pd-144723

    72. Ac-1158

    73. Ccg-221247

    74. Cs-1247

    75. Db00230

    76. Ks-5378

    77. Nsc 759256

    78. (s)-3-aminomethyl-5-methylhexanoic Acid

    79. Ncgc00346738-01

    80. 121ge001

    81. Bp163672

    82. Hy-17414

    83. (s)-3-aminomethyl-5-methyl-hexanoic Acid

    84. Am20080369

    85. Cas-148553-50-8

    86. P2840

    87. En300-92104

    88. (3s)-3-(aminomethyl)-5-methyl Hexanoic Acid

    89. (s)-(+)-3-aminomethyl-5-methylhexanoic Acid

    90. D02716

    91. Ab01563007_01

    92. 553p508

    93. A808784

    94. Q412174

    95. Sr-01000942257

    96. Sr-01000942257-2

    97. Pregabalin, Europepharmacopoeia (ep) Reference Standard

    98. Z2757554242

    99. 1414928-41-8

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 159.23 g/mol
    Molecular Formula C8H17NO2
    XLogP3-1.6
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count5
    Exact Mass159.125928785 g/mol
    Monoisotopic Mass159.125928785 g/mol
    Topological Polar Surface Area63.3 Ų
    Heavy Atom Count11
    Formal Charge0
    Complexity123
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameLyrica
    PubMed HealthPregabalin (By mouth)
    Drug ClassesAnticonvulsant, Neuropathic Pain Agent
    Drug LabelPregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:Pregabalin is a white to off-white, crystalline solid with...
    Active IngredientPregabalin
    Dosage FormCapsule; Solution
    Routeoral; Oral
    Strength20mg/ml; 200mg; 25mg; 150mg; 300mg; 75mg; 100mg; 50mg; 225mg
    Market StatusPrescription
    CompanyPf Prism; Cp Pharms

    2 of 4  
    Drug NamePregabalin
    PubMed HealthPregabalin (By mouth)
    Drug ClassesAnticonvulsant, Neuropathic Pain Agent
    Drug LabelPregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:Pregabalin is a white to off-white, crystalline solid with...
    Active IngredientPregabalin
    Dosage FormCapsule; Solution
    Routeoral; Oral
    Strength20mg/ml; 200mg; 25mg; 150mg; 300mg; 75mg; 100mg; 50mg; 225mg
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Apotex; Lupin; Sandoz; Watson Labs; Actavis Elizabeth; Teva Pharms; Wockhardt Usa

    3 of 4  
    Drug NameLyrica
    PubMed HealthPregabalin (By mouth)
    Drug ClassesAnticonvulsant, Neuropathic Pain Agent
    Drug LabelPregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:Pregabalin is a white to off-white, crystalline solid with...
    Active IngredientPregabalin
    Dosage FormCapsule; Solution
    Routeoral; Oral
    Strength20mg/ml; 200mg; 25mg; 150mg; 300mg; 75mg; 100mg; 50mg; 225mg
    Market StatusPrescription
    CompanyPf Prism; Cp Pharms

    4 of 4  
    Drug NamePregabalin
    PubMed HealthPregabalin (By mouth)
    Drug ClassesAnticonvulsant, Neuropathic Pain Agent
    Drug LabelPregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:Pregabalin is a white to off-white, crystalline solid with...
    Active IngredientPregabalin
    Dosage FormCapsule; Solution
    Routeoral; Oral
    Strength20mg/ml; 200mg; 25mg; 150mg; 300mg; 75mg; 100mg; 50mg; 225mg
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Apotex; Lupin; Sandoz; Watson Labs; Actavis Elizabeth; Teva Pharms; Wockhardt Usa

    4.2 Therapeutic Uses

    Pregabalin is indicated for management of post-herpetic neuralgia. /Included in US product label/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2412

    Pregabalin is indicated for management of neuropathic pain associated with diabetic peripheral neuropathy. /Included in US product labe/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2412

    Pregabalin is indicated as an adjunctive therapy for adult patients with partial onset seizures. /Included in US product label/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2412

    The U.S. Food and Drug Administration ... has approved Lyrica (pregabalin), the first drug to treat fibromyalgia, a disorder characterized by pain, fatigue and sleep problems.

    FDA; FDA News (P07-107). Available from, as of July 31, 2007: https://www.fda.gov/bbs/topics/NEWS/2007/NEW01656.html

    4.3 Drug Warning

    Known hypersensitivity to pregabalin or any ingredient in the formulation.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2247

    Because of the possibility of increased seizure frequency, anticonvulsant drugs, including pregabalin, should be withdrawn gradually and dosage reduced slowly over at least 1 week. Abrupt discontinuance of pregabalin has been associated with insomnia, nausea, headache, and diarrhea.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2247

    In controlled studies, blurred vision, which was reported in 6 or 2% of patients receiving pregabalin or placebo, respectively, resolved in the majority of cases with continued dosing; less than 1% of patients required discontinuance of the drug. In addition, decreased visual acuity was reported in 7 or 5% of patients receiving pregabalin or placebo, respectively, while visual field changes were detected in 13 or 12% of patients receiving the drug or placebo, respectively, and funduscopic changes were observed in 2% of patients receiving pregabalin or placebo. The clinical importance of these ophthalmologic findings has not been elucidated. If visual disturbance persists, further ocular assessment should be considered, while more frequent assessment is recommended in patients who already are monitored for ocular conditions.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2247

    Weight gain, which was related to dosage and duration of exposure to pregabalin, has been reported in patients receiving pregabalin. Weight gain did not appear to be associated with baseline body mass index (BMI), gender, or age and was not limited to patients with edema.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2247

    For more Drug Warnings (Complete) data for PREGABALIN (20 total), please visit the HSDB record page.

    4.4 Drug Indication

    Pregabalin is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, fibromyalgia, neuropathic pain associated with spinal cord injury, and as adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older.

    FDA Label

    * Neuropathic pain:

    - Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.

    * Epilepsy :

    - Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

    * Generalised anxiety disorder:

    - Lyrica is indicated for the treatment of generalised anxiety disorder (GAD) in adults.

    * Epilepsy :

    Pregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

    * Generalised Anxiety Disorder:

    Pregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

    * Neuropathic pain:

    Pregabalin Mylan is indicated for the treatment of peripheral and central neuropathic pain in adults.

    * Epilepsy :

    Pregabalin Mylan is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

    * Generalised Anxiety Disorder:

    Pregabalin Mylan is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

    Neuropathic pain

    - Pregabalin Pfizer is indicated for the treatment of peripheral and central neuropathic pain in adults.

    Epilepsy

    - Pregabalin Pfizer is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

    Generalised Anxiety Disorder

    - Pregabalin Pfizer is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

    * Neuropathic pain:

    - Pregabalin Zentiva k. s. is indicated for the treatment of peripheral and central neuropathic pain in adults.

    * Epilepsy :

    - Pregabalin Zentiva k. s. is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

    * Generalised anxiety disorder:

    - Pregabalin Zentiva k. s. is indicated for the treatment of generalised anxiety disorder (GAD) in adults.

    Epilepsy

    - Pregabalin Accord is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

    Generalised Anxiety Disorder

    - Pregabalin Accord is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

    * Neuropathic pain:

    - Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults.

    * Epilepsy :

    - Pregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

    * Generalised anxiety disorder:

    - Pregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults.

    * Epilepsy :

    Pregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

    * Generalised Anxiety Disorder:

    Pregabalin Sandoz GmbH is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

    * Neuropathic pain:

    Pregabalin Sandoz is indicated for the treatment of peripheral and central neuropathic pain in adults.

    * Epilepsy :

    Pregabalin Sandoz is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

    * Generalised Anxiety Disorder:

    Pregabalin Sandoz is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

    Alleviation of acute anxiety and fear associated with transportation and veterinary visits.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Although the structure of pregabalin is similar to gamma-aminobutyric acid (GABA), it does not bind to GABA receptors. Instead, it binds the alpha2-delta subunit of presynaptic voltage-gated calcium channels in the central nervous system. Pregabalin does not modulate dopamine receptors, serotonin receptors, opiate receptors, sodium channels or cyclooxygenase activity.

    5.2 MeSH Pharmacological Classification

    Anti-Anxiety Agents

    Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. (See all compounds classified as Anti-Anxiety Agents.)

    Analgesics

    Compounds capable of relieving pain without the loss of CONSCIOUSNESS. (See all compounds classified as Analgesics.)

    Calcium Channel Blockers

    A class of drugs that act by selective inhibition of calcium influx through cellular membranes. (See all compounds classified as Calcium Channel Blockers.)

    Anticonvulsants

    Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)

    5.3 ATC Code

    N03AX16

    N03AX16

    N03AX16

    N03AX16

    N03AX16

    N03AX16

    N03AX16

    N03AX16

    N03AX16

    QN03AX16

    N03AX16

    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

    N - Nervous system

    N03 - Antiepileptics

    N03A - Antiepileptics

    N03AX - Other antiepileptics

    N03AX16 - Pregabalin

    5.4 Absorption, Distribution and Excretion

    Absorption

    After oral dosing administered in the fasted state, pregabalin absorption is rapid, and extensive. Pregabalin oral bioavailability is reported to be 90% regardless of the dose. Cmax is attained within 1.5 hours after single or multiple doses, and steady state is attained within 24-48 hours with repeated administration. Both Cmax and AUC appear to be dose proportional. Food decreases the rate of pregabalin absorption and as a result, lowers the Cmax by an estimated 25-30% and increases the Tmax to approximately 3 hours. However, the effect of food does not appear to impact the total absorption of pregabalin in a way that is clinically relevant. As a result, pregabalin can be administered with or without food.

    Route of Elimination

    Pregabalin is almost exclusively eliminated in the urine. Further, based on preclinical studies, pregabalin does not appear to undergo racemization to the R enantiomer in the body.

    Volume of Distribution

    After oral administration of pregabalin, the reported apparent volume of distribution is roughly 0.5 L/kg. Although pregabalin is not very lipophilic, it is able to cross the blood brain barrier(BBB). System L transporters facilitate the transport of large amino acids across the BBB and it has been confirmed that pregabalin is a substrate. This information suggests that system L transporters are responsible for pregabalin uptake into the BBB. In rat models, pregabalin has been shown to cross the placenta.

    Clearance

    In young healthy subjects the mean renal clearance is estimated to be 67.0 to 80.9 mL mL/min. Given pregabalin's lack of plasma protein binding, this clearance rate suggests that renal tubular reabsorption is involved.

    Pregabalin is well absorbed after oral administration ...

    Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2539

    Following oral administration of pregabalin capsules under fasting conditions, peak plasma concentrations occur within 1.5 hours. Pregabalin oral bioavailability is >/=90% and is independent of dose. Following single- (25 to 300 mg) and multiple-dose (75 to 900 mg/day) administration, maximum plasma concentrations (C max ) and area under the plasma concentration-time curve (AUC) values increase linearly. Following repeated administration, steady state is achieved within 24 to 48 hours. Multiple-dose pharmacokinetics can be predicted from single-dose data.

    Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2539

    The rate of pregabalin absorption is decreased when given with food, resulting in a decrease in Cmax of approximately 25% to 30% and an increase in Tmax to approximately 3 hours. However, administration of pregabalin with food has no clinically relevant effect on the total absorption of pregabalin. Therefore, pregabalin can be taken with or without food.

    Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2539

    Pregabalin does not bind to plasma proteins. The apparent volume of distribution of pregabalin following oral administration is approximately 0.5 L/kg. Pregabalin is a substrate for system L transporter which is responsible for the transport of large amino acids across the blood brain barrier. Although there are no data in humans, pregabalin has been shown to cross the blood brain barrier in mice, rats, and monkeys. In addition, pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating rats.

    Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2539

    For more Absorption, Distribution and Excretion (Complete) data for PREGABALIN (8 total), please visit the HSDB record page.

    5.5 Metabolism/Metabolites

    Less than 2% of pregabalin is metabolized and it is excreted virtually unchanged in the urine.

    Pregabalin undergoes negligible metabolism in humans. Following a dose of radiolabeled pregabalin, approximately 90% of the administered dose was recovered in the urine as unchanged pregabalin. The N-methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted for 0.9% of the dose. In preclinical studies, pregabalin (S-enantiomer) did not undergo racemization to the R-enantiomer in mice, rats, rabbits, or monkeys.

    Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2540

    5.6 Biological Half-Life

    The elimination half life of pregabalin is 6.3 hours.

    Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug with a mean elimination half-life of 6.3 hours in subjects with normal renal function.

    Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2540

    5.7 Mechanism of Action

    Although the mechanism of action has not been fully elucidated, studies involving structurally related drugs suggest that presynaptic binding of pregabalin to voltage-gated calcium channels is key to the antiseizure and antinociceptive effects observed in animal models. By binding presynaptically to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system, pregabalin modulates the release of several excitatory neurotransmitters including glutamate, substance-P, norepinephrine, and calcitonin gene related peptide. In addition, pregabalin prevents the alpha2-delta subunit from being trafficked from the dorsal root ganglia to the spinal dorsal horn, which may also contribute to the mechanism of action. Although pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), it does not bind directly to GABA or benzodiazepine receptors.

    Pregabalin is an anticonvulsant that is structurally related to the inhibitory CNS neurotransmitter gamma-aminobutyric acid (GABA). Pregabalin also has demonstrated analgesic activity. Although pregabalin was developed as a structural analog of GABA, the drug does not bind directly to GABA-A, GABA-B, or benzodiazepine receptors; does not augment GABA-A responses in cultured neurons; and does not alter brain concentrations of GABA in rats or affect GABA uptake or degradation. However, in cultured neurons, prolonged application of pregabalin increases the density of GABA transporter protein and increases the rate of functional GABA transport.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2248

    Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in CNS tissues. ... In vitro, pregabalin reduces the calcium-dependent release of several neurotransmitters, including glutamate, norepinephrine, and substance P, possibly by modulation of calcium channel function.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2248

    Pregabalin does not block sodium channels, is not active at opiate receptors, and does not alter cyclooxygenase enzyme activity. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake.

    Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2539

    Pregabalin is a potent ligand for the alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system that exhibits potent anticonvulsant, analgesic, and anxiolytic activity in a range of animal models. ... Potent binding to the alpha-2-delta site reduces depolarization-induced calcium influx with a consequential modulation in excitatory neurotransmitter release. Pregabalin has no demonstrated effects on GABAergic mechanisms. ...

    PMID:15315511 Ben-Menachem E; Epilepsia 45 Suppl 6: 13-8 (2004)

    For more Mechanism of Action (Complete) data for PREGABALIN (6 total), please visit the HSDB record page.

    API SUPPLIERS

    read-more
    read-more
    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    Listed Suppliers

    read-more
    read-more

    01

    HRV Pharma

    India
    arrow
    AOCS Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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

    Pregabalin

    About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

    HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    HRV Global Life Sciences

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    02

    Century Pharmaceuticals

    India
    arrow
    Vietnam Medi-Pharm Expo
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCentury has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.

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

    Pregabalin

    About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience manufacturing APIs for major pharma companies in India and abroad. Its products are made in compliance with...

    Century Pharmaceuticals, established in 1982, has 40 years of experience manufacturing APIs for major pharma companies in India and abroad. Its products are made in compliance with cGMP, 21 CFR, and ICH guidelines, and it also produces intermediates and develops new APIs as per client requirements. The company conducts biotechnological research on human therapeutic proteins, including treatments for asthma, mastocytosis, and basophilic leukemia, and supplies research-grade biotech and animal health products. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Century Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    03

    Dr. Reddy's Laboratories

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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

    Pregabalin

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
    Dr Reddy Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    04

    LGM Pharma

    U.S.A
    arrow
    CPhI North America
    Booth #730
    • fda
    • EDQM
    • WHO-GMP

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

    Contact Supplier Contact Supplier
    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Pregabalin

    About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...

    LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product CDMO, offering formulation, analytical method development and testing, regulatory support, and commercial manufacturing. Supported by a network of over 220 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    LGM Pharma CB

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    05

    Metrochem API Private Limited

    India
    arrow
    Vietnam Medi-Pharm Expo
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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

    Pregabalin

    About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

    Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
    Metrochem

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    06

    Rochem International Inc

    U.S.A
    arrow
    Sweets & Snacks Expo
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

    Contact Supplier Contact Supplier
    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Pregabalin

    About the Company : Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered i...

    Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered in Hauppauge, New York, it operates 16 offices worldwide. Rochem’s operations are fully cGMP compliant and have been audited by the USFDA and several multinational organizations. The company also trains and audits its partners to ensure FDA-compliant technologies and systems. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Rochem

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    07

    Temad Co

    Iran
    arrow
    AOCS Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTemad- We think of world-class quality.

    Contact Supplier Contact Supplier
    Flag Iran
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Pregabalin

    About the Company : Temad Co., established in 1997, is one of Iran's largest API producers and an innovative manufacturer of narcotic and non-narcotic products in the Middle East. It complies with Ira...

    Temad Co., established in 1997, is one of Iran's largest API producers and an innovative manufacturer of narcotic and non-narcotic products in the Middle East. It complies with Iranian GMP and international standards like ISO 9001/14001/17025/45001 and OHSAS 18001. Temad manufactures over 115 pharmaceutical products, meeting GMP and WHO standards, and exports to 45 countries worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Temad

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    08

    Gonane Pharma

    India
    arrow
    iPHEX India
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothGonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.

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

    Pregabalin

    About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...

    Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology products. The company is supported by a dedicated team and promoters with over 25 years of experience in manufacturing, product promotion, and regulatory audits across markets including the EU, Mexico, China, Korea, and Russia. Gonane Pharma is also engaged with Japanese customers and continues to expand into new markets. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Gonane Pharma

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    09

    Jai Radhe Sales

    India
    arrow
    AOCS Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

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

    Pregabalin

    About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...

    Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and regulatory support, and strives for global standards. Known for quality and affordability, it has established a niche through innovative methods and exports to nearly every continent. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Jai Radhe Sales

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    10

    Rusan Pharma

    India
    arrow
    CPhI Milan
    Booth #5B137
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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

    Pregabalin

    About the Company : Rusan Pharma is a global pharmaceutical company specializing in addiction and pain management, manufacturing APIs and formulations for controlled substances. Its facilities are GMP...

    Rusan Pharma is a global pharmaceutical company specializing in addiction and pain management, manufacturing APIs and formulations for controlled substances. Its facilities are GMP-approved by multiple international agencies, and it holds CEP approval for key APIs like Buprenorphine, Fentanyl, and Methadone. Rusan also produces transdermal patches, depot injections, and implants for long-acting treatments. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Rusan Pharma

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    Only 10 entries up to this point, click to access all click full view read-more
    click full view
    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    DRUG PRODUCT COMPOSITIONS

    Do you need Business Intel? Ask us

    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 165M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 165MG

    USFDA APPLICATION NUMBER - 209501

    read-more

    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 330M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 330MG

    USFDA APPLICATION NUMBER - 209501

    read-more

    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 82.5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 82.5MG

    USFDA APPLICATION NUMBER - 209501

    read-more

    DOSAGE - CAPSULE;ORAL - 100MG

    USFDA APPLICATION NUMBER - 21446

    read-more

    DOSAGE - CAPSULE;ORAL - 150MG

    USFDA APPLICATION NUMBER - 21446

    read-more

    DOSAGE - CAPSULE;ORAL - 200MG

    USFDA APPLICATION NUMBER - 21446

    read-more

    DOSAGE - CAPSULE;ORAL - 225MG

    USFDA APPLICATION NUMBER - 21446

    read-more

    DOSAGE - CAPSULE;ORAL - 25MG

    USFDA APPLICATION NUMBER - 21446

    read-more

    DOSAGE - CAPSULE;ORAL - 300MG

    USFDA APPLICATION NUMBER - 21446

    read-more

    DOSAGE - CAPSULE;ORAL - 50MG

    USFDA APPLICATION NUMBER - 21446

    read-more

    DOSAGE - CAPSULE;ORAL - 75MG

    USFDA APPLICATION NUMBER - 21446

    read-more

    Related Excipient Companies

    Upload your portfolio for free, ask us

    Excipients by Applications

    Click here to find the perfect excipient manufacturers by their capabilities

    Fillers, Diluents & Binders

    read-more
    read-more

    Direct Compression

    read-more
    read-more

    Granulation

    read-more
    read-more

    Taste Masking

    read-more
    read-more

    Empty Capsules

    read-more
    read-more

    Coating Systems & Additives

    read-more
    read-more

    Lubricants & Glidants

    read-more
    read-more

    Co-Processed Excipients

    read-more
    read-more

    Film Formers & Plasticizers

    read-more
    read-more

    Topical

    read-more
    read-more

    Chewable & Orodispersible Aids

    read-more
    read-more

    Thickeners and Stabilizers

    read-more
    read-more

    Disintegrants & Superdisintegrants

    read-more
    read-more

    Parenteral

    read-more
    read-more

    Controlled & Modified Release

    read-more
    read-more

    Emulsifying Agents

    read-more
    read-more

    API Stability Enhancers

    read-more
    read-more

    Solubilizers

    read-more
    read-more

    Surfactant & Foaming Agents

    read-more
    read-more

    Digital Content read-more

    Create Content with PharmaCompass, ask us

    NEWS #PharmaBuzz

    read-more
    read-more

    Global Sales Information

    Do you need Business Intel? Ask us

    Market Place

    Do you need sourcing support? Ask us

    Patents & EXCLUSIVITIES

    Check the patents & exclusivity for this product

    REF. STANDARDS & IMPURITIES

    Upload your portfolio for free, ask us

    USP

    read-more
    read-more

    ANALYTICAL

    Upload your methods for free, ask us

    ABOUT THIS PAGE

    Looking for 148553-50-8 / Pregabalin API manufacturers, exporters & distributors?

    Pregabalin manufacturers, exporters & distributors 1

    46

    PharmaCompass offers a list of Pregabalin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Pregabalin manufacturer or Pregabalin supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pregabalin manufacturer or Pregabalin supplier.

    API | Excipient name

    Pregabalin

    Synonyms

    148553-50-8, Lyrica, (s)-3-(aminomethyl)-5-methylhexanoic acid, 3-isobutyl gaba, (3s)-3-(aminomethyl)-5-methylhexanoic acid, Ci-1008

    Cas Number

    148553-50-8

    Unique Ingredient Identifier (UNII)

    55JG375S6M

    About Pregabalin

    A gamma-aminobutyric acid (GABA) derivative that functions as a CALCIUM CHANNEL BLOCKER and is used as an ANTICONVULSANT as well as an ANTI-ANXIETY AGENT. It is also used as an ANALGESIC in the treatment of NEUROPATHIC PAIN and FIBROMYALGIA.

    LYRICA CR Manufacturers

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

    LYRICA CR Suppliers

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

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

    LYRICA CR USDMF

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

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

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

    LYRICA CR JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The LYRICA CR Drug Master File in Japan (LYRICA CR JDMF) empowers LYRICA CR API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the LYRICA CR JDMF during the approval evaluation for pharmaceutical products. At the time of LYRICA CR JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of LYRICA CR suppliers with JDMF on PharmaCompass.

    LYRICA CR KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a LYRICA CR Drug Master File in Korea (LYRICA CR KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of LYRICA CR. The MFDS reviews the LYRICA CR KDMF as part of the drug registration process and uses the information provided in the LYRICA CR KDMF to evaluate the safety and efficacy of the drug.

    After submitting a LYRICA CR KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their LYRICA CR API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of LYRICA CR suppliers with KDMF on PharmaCompass.

    LYRICA CR CEP

    A LYRICA CR CEP of the European Pharmacopoeia monograph is often referred to as a LYRICA CR Certificate of Suitability (COS). The purpose of a LYRICA CR CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of LYRICA CR EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of LYRICA CR to their clients by showing that a LYRICA CR CEP has been issued for it. The manufacturer submits a LYRICA CR CEP (COS) as part of the market authorization procedure, and it takes on the role of a LYRICA CR CEP holder for the record. Additionally, the data presented in the LYRICA CR CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the LYRICA CR DMF.

    A LYRICA CR CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. LYRICA CR CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of LYRICA CR suppliers with CEP (COS) on PharmaCompass.

    LYRICA CR WC

    A LYRICA CR written confirmation (LYRICA CR WC) is an official document issued by a regulatory agency to a LYRICA CR manufacturer, verifying that the manufacturing facility of a LYRICA CR active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting LYRICA CR APIs or LYRICA CR finished pharmaceutical products to another nation, regulatory agencies frequently require a LYRICA CR WC (written confirmation) as part of the regulatory process.

    click here to find a list of LYRICA CR suppliers with Written Confirmation (WC) on PharmaCompass.

    LYRICA CR NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing LYRICA CR as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for LYRICA CR API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture LYRICA CR as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain LYRICA CR and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a LYRICA CR NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of LYRICA CR suppliers with NDC on PharmaCompass.

    LYRICA CR GMP

    LYRICA CR Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of LYRICA CR GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right LYRICA CR GMP manufacturer or LYRICA CR GMP API supplier for your needs.

    LYRICA CR CoA

    A LYRICA CR CoA (Certificate of Analysis) is a formal document that attests to LYRICA CR's compliance with LYRICA CR specifications and serves as a tool for batch-level quality control.

    LYRICA CR CoA mostly includes findings from lab analyses of a specific batch. For each LYRICA CR CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    LYRICA CR may be tested according to a variety of international standards, such as European Pharmacopoeia (LYRICA CR EP), LYRICA CR JP (Japanese Pharmacopeia) and the US Pharmacopoeia (LYRICA CR USP).

    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.
    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty
    • Privacy policy
    • Terms and conditions
    • Disclaimers
    • LinkedIn
    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search