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ACTIVE PHARMA INGREDIENTS

13 API Suppliers, 2 USDMF, 3 EU WC, 3 NDC API, 12 Listed Suppliers, $ API Reference Price

13 API Suppliers
2 USDMF
3 EU WC
3 NDC API
12 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

89 FDF Dossiers, 63 FDA Orange Book, 24 Europe, 2 Listed Dossiers

89 FDF Dossiers
63 FDA Orange Book
24 Europe
2 Listed Dossiers

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 2 SPI Pharma, 1 DKSH, 1 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 7 Actylis, 1 Finar, 1 Kerry, 1 Pluviaendo, 11 Roquette, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Zhejiang Huakang Pharmaceutical

relatedExcipients
2 Rochem International Inc
2 SPI Pharma
1 DKSH
1 Gangwal Healthcare
2 Nanjing Well Pharmaceutical
7 Actylis
1 Finar
1 Kerry
1 Pluviaendo
11 Roquette
1 Shijiazhuang Huaxu Pharmaceutical
1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

10 Film Formers & Plasticizers, 9 Parenteral, 6 Taste Masking, 5 Coating Systems & Additives, 4 Fillers, Diluents & Binders, 3 Topical, 2 Chewable & Orodispersible Aids, 1 Controlled & Modified Release, 1 Co-Processed Excipients, 1 Direct Compression, 1 Solubilizers, 1 Soft Gelatin

excipientsByApplications
10 Film Formers & Plasticizers
9 Parenteral
6 Taste Masking
5 Coating Systems & Additives
4 Fillers, Diluents & Binders
3 Topical
2 Chewable & Orodispersible Aids
1 Controlled & Modified Release
1 Co-Processed Excipients
1 Direct Compression
1 Solubilizers
1 Soft Gelatin

DIGITAL CONTENT

9 NEWS #PharmaBuzz

media
9 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 16 Finished Drug Prices

globalSalesInformation
1 US Medicaid Prescriptions
16 Finished Drug Prices

MARKET PLACE

7 APIs, 1 FDF Dossiers

marketPlace
7 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Exclusivities

patents
1 US Exclusivities

REF. STANDARDS & IMPURITIES

1 USP , 1 Others

otherSolutions
1 USP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 5,303

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

106,810

Annual Reports (USD Million)

Finished Drug Prices

31 RELATED EXCIPIENT COMPANIES

44EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Midazolam hcl, 59467-96-8, Versed, Hypnovel, Midazolam hydrochloride [usan], Ro 21-3981/003

Molecular Formula

C₁₈H₁₄Cl₂FN₃

Molecular Weight

362.2 g/mol

InChI Key

PLYSCVSCYOQVRP-UHFFFAOYSA-N

FDA UNII

W7TTW573JJ

A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.

1 2D Structure

Midazolam Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine;hydrochloride

2.1.2 InChI

InChI=1S/C18H13ClFN3.ClH/c1-11-21-9-13-10-22-18(14-4-2-3-5-16(14)20)15-8-12(19)6-7-17(15)23(11)13;/h2-9H,10H2,1H3;1H

2.1.3 InChI Key

PLYSCVSCYOQVRP-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1=NC=C2N1C3=C(C=C(C=C3)Cl)C(=NC2)C4=CC=CC=C4F.Cl

2.2 Other Identifiers

2.2.1 UNII

W7TTW573JJ

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Dormicum

2. Hydrochloride, Midazolam

3. Maleate, Midazolam

4. Midazolam

5. Midazolam Maleate

6. Ro 21 3981

7. Ro 21-3981

8. Ro 213981

9. Versed

2.3.2 Depositor-Supplied Synonyms

1. Midazolam Hcl

2. 59467-96-8

3. Versed

4. Hypnovel

5. Midazolam Hydrochloride [usan]

6. Ro 21-3981/003

7. Buccolam

8. Midazolam Hydrochloride Civ

9. Nsc-751451

10. W7ttw573jj

11. Shp615

12. Shp-615

13. 8-chloro-6-(2-fluorophenyl)-1-methyl-4h-imidazo[1,5-a][1,4]benzodiazepine Hydrochloride

14. 8-chloro-6-(2-fluorophenyl)-1-methyl-4h-imidazo[1,5-a][1,4]benzodiazepine;hydrochloride

15. Rocam

16. Ro-213981001

17. 8-chloro-6-(2-fluorophenyl)-1-methyl-4h-imidazo(1,5-a)(1,4)benzodiazepine Hydrochloride

18. Dsstox_cid_27824

19. Dsstox_rid_82587

20. Dsstox_gsid_47846

21. Midazolam Hydrochloride (usan)

22. Cas-59467-96-8

23. Ncgc00168254-01

24. Einecs 261-776-6

25. Unii-w7ttw573jj

26. Ro-21-3981/003

27. Versed Hydrochloride

28. Versed (tn)

29. Seizalam

30. Hypnovel Hydrochloride

31. Midazolam Hydrochloride Preservative Free

32. Midazolam (hydrochloride)

33. Schembl41265

34. Mls001401415

35. Chebi:6932

36. Chembl1200420

37. Dtxsid8047846

38. Hy-b0676a

39. Bcp15579

40. Midazolam Hydrochloride [mi]

41. Tox21_112613

42. Nsc751451

43. Midazolam Hydrochloride [hsdb]

44. Akos024457308

45. Tox21_112613_1

46. Ccg-100983

47. Midazolam Hydrochloride [mart.]

48. Midazolam Hydrochloride [vandf]

49. Nc00233

50. Nsc 751451

51. 4h-imidazo(1,5-a)(1,4)benzodiazepine, 8-chloro-6-(2-fluorophenyl)-1-methyl-, Hydrochloride

52. 8-chloro-6-(2-fluorophenyl)-1-methyl-4h-imidazo(1,5-a)(1,4)benzodiazepine Monohydrochloride

53. 8-chloro-6-(o-fluorophenyl)-1-methyl-4h-imidazo(1,5-a)(1,4)benzodiazepine Monohydrochloride

54. Midazolam Hydrochloride [who-dd]

55. Ncgc00168254-02

56. 4h-imidazo(1,5-a)(1,4)benzodiazepine, 8-chloro-6-(2-fluorophenyl)-1-methyl-, Monohydrochloride

57. Smr000469160

58. Midazolam Hydrochloride [orange Book]

59. Midazolam Hydrochloride Civ [usp-rs]

60. D00696

61. 467m968

62. Q27292444

63. 4h-imidazo[1,5a][1,4]benzodiazepine, 8-chloro-6-(2-fluorophenyl)-1-methyl-, Hydrochloride

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₈H₁₄Cl₂FN₃
Molecular Weight	362.2 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	1
Exact Mass	361.0548810 g/mol
Monoisotopic Mass	361.0548810 g/mol
Topological Polar Surface Area	30.2 Å²
Heavy Atom Count	24
Formal Charge	0
Complexity	471
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Midazolam hydrochloride
Drug Label	Midazolam hydrochloride is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 1 mg or 5 mg midazolam USP compou...
Active Ingredient	Midazolam hydrochloride
Dosage Form	Syrup; Injectable
Route	Injection; Oral
Strength	eq 2mg base/ml; eq 1mg base/ml; eq 5mg base/ml
Market Status	Prescription
Company	Wockhardt; Ranbaxy; Bedford; Hospira; Gland Pharma; Roxane; Hi Tech Pharma; Paddock; Fresenius Kabi Usa; Hikma Maple; Bedford Labs; Akorn

2 of 4
Drug Name	Midazolam hydrochloride preservative free
Active Ingredient	Midazolam hydrochloride
Dosage Form	Injectable
Route	Injection
Strength	eq 1mg base/ml; eq 5mg base/ml
Market Status	Prescription
Company	Sagent Strides; Hospira; Bd Rx

3 of 4
Drug Name	Midazolam hydrochloride
Drug Label	Midazolam hydrochloride is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 1 mg or 5 mg midazolam USP compou...
Active Ingredient	Midazolam hydrochloride
Dosage Form	Syrup; Injectable
Route	Injection; Oral
Strength	eq 2mg base/ml; eq 1mg base/ml; eq 5mg base/ml
Market Status	Prescription
Company	Wockhardt; Ranbaxy; Bedford; Hospira; Gland Pharma; Roxane; Hi Tech Pharma; Paddock; Fresenius Kabi Usa; Hikma Maple; Bedford Labs; Akorn

4 of 4
Drug Name	Midazolam hydrochloride preservative free
Active Ingredient	Midazolam hydrochloride
Dosage Form	Injectable
Route	Injection
Strength	eq 1mg base/ml; eq 5mg base/ml
Market Status	Prescription
Company	Sagent Strides; Hospira; Bd Rx

4.2 Drug Indication

Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from three months to less than 18 years).

Buccolam must only be used by parents / carers where the patient has been diagnosed to have epilepsy.

For infants between three and six months of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.

Epileptic seizures

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Adjuvants, Anesthesia

Agents that are administered in association with anesthetics to increase effectiveness, improve delivery, or decrease required dosage. (See all compounds classified as Adjuvants, Anesthesia.)

Anesthetics, Intravenous

Ultrashort-acting anesthetics that are used for induction. Loss of consciousness is rapid and induction is pleasant, but there is no muscle relaxation and reflexes frequently are not reduced adequately. Repeated administration results in accumulation and prolongs the recovery time. Since these agents have little if any analgesic activity, they are seldom used alone except in brief minor procedures. (From AMA Drug Evaluations Annual, 1994, p174) (See all compounds classified as Anesthetics, Intravenous.)

GABA Modulators

Substances that do not act as agonists or antagonists but do affect the GAMMA-AMINOBUTYRIC ACID receptor-ionophore complex. GABA-A receptors (RECEPTORS, GABA-A) appear to have at least three allosteric sites at which modulators act: a site at which BENZODIAZEPINES act by increasing the opening frequency of GAMMA-AMINOBUTYRIC ACID-activated chloride channels; a site at which BARBITURATES act to prolong the duration of channel opening; and a site at which some steroids may act. GENERAL ANESTHETICS probably act at least partly by potentiating GABAergic responses, but they are not included here. (See all compounds classified as GABA Modulators.)

Hypnotics and Sedatives

Drugs used to induce drowsiness or sleep or to reduce psychological excitement or anxiety. (See all compounds classified as Hypnotics and Sedatives.)

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.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Benzodiazepines [CS]; Benzodiazepine [EPC]

5.3 ATC Code

N05CD08

API SUPPLIERS

01

Cohance Lifesciences

India

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

Medlab Asia & Asia Health

Not Confirmed

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

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India

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USDMF CEP/COS JDMF EU-WC

NDC

KDMF VMF ASMF

AUDIT

02

Jai Radhe Sales

India

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

Medlab Asia & Asia Health

Not Confirmed

Jai Radhe Sales is your partner for all your sourcing needs.

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India

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

03

Nortec Quimica

Brazil

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

Medlab Asia & Asia Health

Not Confirmed

Nortec Quimica is the largest API manufacturer in Latin America.

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Brazil

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

04

Supriya Lifescience

India

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

Medlab Asia & Asia Health

Not Confirmed

Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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India

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

05

F.I.S. Fabbrica Italiana Sintetici

Italy

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

Medlab Asia & Asia Health

Not Confirmed

06

Cambrex Corporation

U.S.A

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

Medlab Asia & Asia Health

Not Confirmed

07

Centaur Pharmaceuticals

India

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

Medlab Asia & Asia Health

Not Confirmed

08

Precise Group

India

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

Medlab Asia & Asia Health

Not Confirmed

09

Precise Group

India

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

Medlab Asia & Asia Health

Not Confirmed

10

Formil Quimica Ltd

Brazil

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

Medlab Asia & Asia Health

Not Confirmed

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USDMF

01

Cambrex Profarmaco Milano Srl

U.S.A

Medlab Asia & Asia Health

Not Confirmed

02

Fis Fabbrica Italiana Sintetici Spa

Italy

Medlab Asia & Asia Health

Not Confirmed

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EU WC

01

Cohance Lifesciences

India

Medlab Asia & Asia Health

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

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Midazolam Hydrochloride IH

Date of Issue : 2022-07-07

Valid Till : 2025-07-21

Written Confirmation Number : WC-0150

Address of the Firm : R. S. No. 50/1, Mukteswarapuram (V), Jaggalahpet (M), Krishna -District- 521175,...

02

Centaur Pharmaceuticals

India

Medlab Asia & Asia Health

Not Confirmed

03

Lake Chemicals

India

Medlab Asia & Asia Health

Not Confirmed

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NDC API

01

COHANCE LIFESCIENCES LIMITED

India

Medlab Asia & Asia Health

Not Confirmed

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

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MIDAZOLAM HYDROCHLORIDE

NDC Package Code : 17511-134

Start Marketing Date : 2020-11-28

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (20mg/20mg)

Marketing Category : BULK INGREDIENT

02

CAMBREX PROFARMACO MILANO SRL

U.S.A

Medlab Asia & Asia Health

Not Confirmed

03

F.I.S. FABBRICA ITALIANA SINTETICI ...

Italy

Medlab Asia & Asia Health

Not Confirmed

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Listed Suppliers

01

Cohance Lifesciences

India

Medlab Asia & Asia Health

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

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India

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Midazolam Hydrochloride

About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...

Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our expertise in complex chemistries, we provide end-to-end CDMO services to global innovators and have delivered numerous projects from concept to commercialization over the years.As a global API player, we serve customers across nearly 60 countries with 80+ molecules backed by robust R&D, regulatory capabilities and manufacturing infrastructure. We are among the top backward integrated exporters of pellets and have strong development and manufacturing capabilities.

02

Jai Radhe Sales

India

Medlab Asia & Asia Health

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Midazolam Hydrochloride

About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.

03

Nortec Quimica

Brazil

Medlab Asia & Asia Health

Not Confirmed

Nortec Quimica is the largest API manufacturer in Latin America.

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Brazil

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Midazolam Hydrochloride

About the Company : Nortec Química stands as the largest manufacturer of Active Pharmaceutical Ingredients (IFAs) in Latin America, embarking on its mission to ensure the availability of quality medi...

Nortec Química stands as the largest manufacturer of Active Pharmaceutical Ingredients (IFAs) in Latin America, embarking on its mission to ensure the availability of quality medicines with IFAs developed in Brazil. The company's approach involves leveraging the expertise of major National Research Centers and tapping into the experience of the Brazilian Chemical and Petrochemical Industry. Nortec Química plays a significant role in the Brazilian pharmaceutical landscape and the Unified Health System (SUS), producing APIs for branded, generic, and similar medicines, as well as medicines dedicated to addressing neglected diseases.

04

Supriya Lifescience

India

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Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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Midazolam Hydrochloride

About the Company : Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Su...

Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Supriya follows industry standards and constantly improves to deliver quality products. Its facility is 47,000 square meters with dedicated areas for warehouse, QA, QC, R&D, production and finished products. The current capacity is 550 KL, with plans to expand to over 1000 KL by 2024. Supriya has 14 active USDMFs, 8 active CEPs, strong R&D and compliant facilities worldwide. Supriya works with innovators, generic companies, and as a CMO.

05

Centaur Pharmaceuticals

India

Medlab Asia & Asia Health

Not Confirmed

06

Formil Quimica Ltd

Brazil

Medlab Asia & Asia Health

Not Confirmed

07

Fuan Pharmaceutical

China

Medlab Asia & Asia Health

Not Confirmed

08

Lake Chemicals

India

Medlab Asia & Asia Health

Not Confirmed

09

Precise Group

India

Medlab Asia & Asia Health

Not Confirmed

Precise Group

India

Medlab Asia & Asia Health

Not Confirmed

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About the Company : Indian Pharmaceutical Company, Precise Group is emerging as a global player in several verticals in healthcare. The Mumbai based drug manufacturing company’s strength lies in a s...

Indian Pharmaceutical Company, Precise Group is emerging as a global player in several verticals in healthcare. The Mumbai based drug manufacturing company’s strength lies in a strong network of industry professionals who care capable of handling the development of APIs, several Ready-to-fill Pellets and other intermediates, and chemicals. The company’s influence has a universal reach coordinating with multi-levels of global healthcare service providers for generic drugs. It holds a valued equity in niche pharma sectors in USA, Europe and Africa. Precise Group’s business encompasses the protection of the interest of their shareholders, is complaint with international regulatory bodies and meets the protocol favored in any region as a pharma suppler spanning developed and new markets. The technologically advanced manufacturing hub near Mumbai conducts manufacturing programs to sustain quality drugs at cost effect prices.

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10

Precise Group

India

Medlab Asia & Asia Health

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Precise Group

India

Medlab Asia & Asia Health

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API Reference Price

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