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GLAND PHARMA LIMITED
FDA Orange Book

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.

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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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

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pharmacompass-2-m-2026-03-23

GLAND PHARMA LIMITED

VIRTUAL BOOTH, Contact Details

VIRTUAL BOOTH
CONTACT DETAILS
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 223 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
223 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

90 All APIs, 75 USDMF, 4 CEP/COS, 30 EU WC, 1 KDMF, 39 Listed APIs

90 All APIs
75 USDMF
4 CEP/COS
30 EU WC
1 KDMF
39 Listed APIs

DEVELOPMENTS

13 Drugs in Development

13 Drugs in Development

FINISHED DOSAGE FORMULATIONS

239 FDF Dossiers, 239 FDA Orange Book

239 FDF Dossiers
239 FDA Orange Book

EXCIPIENTS

1 All Excipients, 1 USDMF

1 All Excipients
1 USDMF

INSPECTIONS & REGISTRATIONS

35 FDA, 7 EDQM, 2 WHO-GMP, 6 GDUFA, 1 Third-Party Audit

35 FDA
7 EDQM
2 WHO-GMP
6 GDUFA
1 Third-Party Audit

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FILTER :

filter Active Ingredients Reset all filters

239 All

01 2ACETAMINOPHEN

02 1ACETAZOLAMIDE SODIUM

03 2ADENOSINE

04 1ALCAFTADINE

05 1ALLOPURINOL SODIUM

06 1AMIODARONE HYDROCHLORIDE

07 1ANGIOTENSIN II ACETATE

08 2ARGATROBAN

09 2ARSENIC TRIOXIDE

10 1AZELASTINE HYDROCHLORIDE

11 1AZITHROMYCIN

12 2BIMATOPROST

13 2BORTEZOMIB

14 1BRIMONIDINE TARTRATE

15 1BROMFENAC SODIUM

16 1BUMETANIDE

17 1CALCITRIOL

18 1CANGRELOR

19 4CARBOPLATIN

20 1CARBOPROST TROMETHAMINE

21 2CASPOFUNGIN ACETATE

22 1CETRORELIX ACETATE

23 1CHLOROTHIAZIDE SODIUM

24 1CHLORPROMAZINE HYDROCHLORIDE

25 3CISATRACURIUM BESYLATE

26 1CISPLATIN

27 1CLOFARABINE

28 1CYANOCOBALAMIN

29 2CYTARABINE

30 1DECITABINE

31 2DEFEROXAMINE MESYLATE

32 2DESMOPRESSIN ACETATE

33 2DEXAMETHASONE SODIUM PHOSPHATE

34 3DEXMEDETOMIDINE HYDROCHLORIDE

35 2DEXRAZOXANE HYDROCHLORIDE

36 1DIHYDROERGOTAMINE MESYLATE

37 1DIPHENHYDRAMINE HYDROCHLORIDE

38 3DOCETAXEL

39 1DORZOLAMIDE HYDROCHLORIDE

40 1DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

41 1DOXERCALCIFEROL

42 1DOXORUBICIN HYDROCHLORIDE

43 1DOXYCYCLINE HYCLATE

44 2EDARAVONE

45 7ENOXAPARIN SODIUM

46 2EPHEDRINE SULFATE

47 5EPINEPHRINE

48 2EPOPROSTENOL SODIUM

49 1ERIBULIN MESYLATE

50 1ERTAPENEM SODIUM

51 1ERYTHROMYCIN LACTOBIONATE

52 1ESMOLOL HYDROCHLORIDE

53 2ESOMEPRAZOLE SODIUM

54 1ETOMIDATE

55 4FLUOROURACIL

56 1FLUPHENAZINE DECANOATE

57 1FOMEPIZOLE

58 1FOSCARNET SODIUM

59 1FOSPHENYTOIN SODIUM

60 1FUROSEMIDE

61 1GANIRELIX ACETATE

62 2GEMCITABINE HYDROCHLORIDE

63 1GLYCOPYRROLATE

64 2HALOPERIDOL DECANOATE

65 1HALOPERIDOL LACTATE

66 2HEPARIN SODIUM

67 2IRINOTECAN HYDROCHLORIDE

68 1ISOPROTERENOL HYDROCHLORIDE

69 3KETAMINE HYDROCHLORIDE

70 5KETOROLAC TROMETHAMINE

71 1LABETALOL HYDROCHLORIDE

72 1LACOSAMIDE

73 1LATANOPROST

74 1LATANOPROSTENE BUNOD

75 1LEUCOVORIN CALCIUM

76 3LEVETIRACETAM

77 5LEVOFLOXACIN

78 2LEVOLEUCOVORIN CALCIUM

79 1LINCOMYCIN HYDROCHLORIDE

80 2MAGNESIUM SULFATE

81 1MELPHALAN HYDROCHLORIDE

82 2MEROPENEM

83 1MESNA

84 1METHOCARBAMOL

85 1METOPROLOL TARTRATE

86 1METRONIDAZOLE

87 2MIDAZOLAM

88 2MIDAZOLAM HYDROCHLORIDE

89 3MILRINONE LACTATE

90 3MITOMYCIN

91 1MOXIFLOXACIN HYDROCHLORIDE

92 1NELARABINE

93 2NEOSTIGMINE METHYLSULFATE

94 1NETARSUDIL

95 1NOREPINEPHRINE BITARTRATE

96 4OCTREOTIDE ACETATE

97 3OLOPATADINE HYDROCHLORIDE

98 2ONDANSETRON HYDROCHLORIDE

99 5OXALIPLATIN

100 1PACLITAXEL

101 1PANTOPRAZOLE SODIUM

102 5PHENYLEPHRINE HYDROCHLORIDE

103 1PHYTONADIONE

104 1PLERIXAFOR

105 1POLYMYXIN B SULFATE

106 1POSACONAZOLE

107 2PROCAINAMIDE HYDROCHLORIDE

108 1PROCHLORPERAZINE EDISYLATE

109 1REGADENOSON

110 2ROCURONIUM BROMIDE

111 2ROPIVACAINE HYDROCHLORIDE

112 1SELENIOUS ACID

113 1SUCCINYLCHOLINE CHLORIDE

114 1TEMSIROLIMUS

115 1THIAMINE HYDROCHLORIDE

116 2THIOTEPA

117 2TIMOLOL MALEATE

118 1TIROFIBAN HYDROCHLORIDE

119 1TOBRAMYCIN

120 4TOBRAMYCIN SULFATE

121 2TRANEXAMIC ACID

122 1TRAVOPROST

123 7VANCOMYCIN HYDROCHLORIDE

124 2VASOPRESSIN

125 2VECURONIUM BROMIDE

126 1VERAPAMIL HYDROCHLORIDE

127 1VORICONAZOLE

128 3ZINC SULFATE

129 7ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID

130 1ZIPRASIDONE MESYLATE

131 6ZOLEDRONIC ACID

filter Dosage Reset all filters

239 All

01 1INJECTABLE; INJECTION

02 124INJECTABLE;INJECTION

03 1INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

04 24INJECTABLE;INTRAVENOUS

05 1INJECTABLE;IV (INFUSION)

06 7INJECTABLE;SUBCUTANEOUS

07 7INJECTION

08 2INJECTION;SOLUTION,CONCENTRATE

09 2POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL

10 1POWDER;INTRAMUSCULAR

11 7POWDER;INTRAVENOUS

12 2POWDER;INTRAVENOUS, SUBCUTANEOUS

13 1POWDER;SUBCUTANEOUS

14 2SOLUTION, GEL FORMING/DROPS;OPHTHALMIC

15 18SOLUTION/DROPS;OPHTHALMIC

16 1SOLUTION;DROPS

17 1SOLUTION;IM-IV

18 2SOLUTION;INJECTION

19 2SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

20 31SOLUTION;INTRAVENOUS

21 1SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS

22 1SOLUTION;SUBCUTANEOUS

filter Dosage Strength Reset all filters

239 All

01 10.001MG/ML

02 10.004%

03 20.004MG/ML

04 10.005%

05 10.01%

06 10.02%

07 10.024%

08 10.03%

09 10.05%

10 10.1%

11 10.25%

12 10.25MG/ML

13 20.2MG/ML

14 10.3%

15 10.3MG/1ML

16 10.4MG/5ML (0.08MG/ML)

17 11,000 UNITS/ML

18 11.5GM/1.5ML (1GM/ML)

19 11.5GM/100ML (15MG/ML)

20 110%

21 11000UG/1ML

22 1100MG/100ML (1MG/ML)

23 2100MG/10ML (10MG/ML)

24 1100MG/20ML (5MG/ML)

25 1100MG/5ML (20MG/ML)

26 4100MG/ML

27 1100MG/ML (100MG/ML)

28 3100MG/VIAL

29 110MG/10ML

30 210MG/10ML (1MG/ML)

31 310MG/ML

32 110MG/ML (10MG/ML)

33 110MG/VIAL

34 1120MG/0.8ML (150MG/ML)

35 1125MG/125ML (1MG/ML)

36 1150MG/15ML (10MG/ML)

37 1150MG/ML (150MG/ML)

38 215MG/ML

39 115MG/VIAL

40 1160MG/16ML (10MG/ML)

41 31GM/100ML (10MG/ML)

42 11GM/10ML (100MG/ML)

43 11GM/20ML (50MG/ML)

44 11GM/VIAL

45 11MG/2ML (0.5MG/ML)

46 51MG/ML

47 11MG/ML (1MG/ML)

48 11MG/VIAL

49 12.5%

50 12.5GM/50ML (50MG/ML)

51 12.5MG/ML

52 12.5MG/VIAL

53 1200MG/100ML (2MG/ML)

54 1200MG/20ML (10MG/ML)

55 1200MG/40ML (5MG/ML)

56 1200MG/VIAL

57 120MG/20ML (1MG/ML)

58 120MG/2ML (10MG/ML)

59 120MG/ML

60 220MG/VIAL

61 120UNITS/ML (20UNITS/ML)

62 124MG/1.2ML (20MG/ML)

63 1250MCG/0.5ML

64 1250MG/50ML (5MG/ML)

65 225MG/ML

66 125MG/ML (25MG/ML)

67 12GM/50ML (40MG/ML)

68 22GM/VIAL

69 32MG/ML

70 1300MG/16.7ML (18MG/ML)

71 130MG/0.3ML (100MG/ML)

72 130MG/100ML (0.3MG/ML)

73 130MG/30ML

74 130MG/30ML (1MG/ML)

75 230MG/ML

76 13MG/1ML

77 23MG/ML

78 13UG/1ML

79 1400MG/200ML (2MG/ML)

80 140MG/0.4ML (100MG/ML)

81 140MG/2ML (20MG/ML)

82 140MG/VIAL

83 140UNITS/100ML (0.4UNITS/ML)

84 1450MG/45ML (10MG/ML)

85 14GM/100ML (40MG/ML)

86 14MCG/2ML (2MCG/ML)

87 15,000 UNITS/ML

88 1500MG/100ML

89 1500MG/100ML (5MG/ML)

90 1500MG/10ML (50MG/ML)

91 1500MG/50ML (10MG/ML)

92 1500MG/ML

93 2500MG/VIAL

94 250MG/10ML (5MG/ML)

95 250MG/50ML (1MG/ML)

96 350MG/5ML (10MG/ML)

97 250MG/ML

98 150MG/ML (50MG/ML)

99 450MG/VIAL

100 155UG/1ML

101 15GM/100ML (50MG/ML)

102 15MG/10ML (0.5MG/ML)

103 15MG/ML

104 15MG/VIAL

105 1600MG/60ML (10MG/ML)

106 160MG/0.6ML (100MG/ML)

107 160MG/100ML (0.6MG/ML)

108 160MG/2ML

109 160UG/1ML

110 16GM/250ML (24MG/ML)

111 16MG/ML

112 16UG/1ML

113 170MG/VIAL

114 180MG/0.8ML (100MG/ML)

115 180MG/8ML (10MG/ML)

116 1EQ 0.09% ACID

117 1EQ 0.1% BASE

118 1EQ 0.1MG BASE/ML

119 1EQ 0.2% BASE

120 1EQ 0.25% BASE

121 1EQ 0.25MG BASE/ML

122 1EQ 0.25MG BASE/VIAL

123 1EQ 0.2MG BASE/ML

124 2EQ 0.5% BASE

125 1EQ 0.5MG BASE/ML

126 1EQ 0.5MG BASE/VIAL

127 1EQ 0.7% BASE

128 1EQ 1.25GM BASE/VIAL

129 1EQ 1.2GM BASE/VIAL

130 1EQ 1.5GM BASE/VIAL

131 1EQ 1.5MG BASE/VIAL

132 2EQ 100MG BASE/ML

133 1EQ 100MG BASE/VIAL

134 1EQ 10GM BASE/VIAL

135 1EQ 10MG BASE/10ML (EQ 1MG BASE/ML)

136 3EQ 10MG BASE/ML

137 1EQ 10MG PHOSPHATE/ML

138 1EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)

139 1EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)

140 3EQ 1GM BASE/VIAL

141 4EQ 1MG BASE/ML

142 1EQ 2% BASE

143 1EQ 2% BASE;EQ 0.5% BASE

144 1EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)

145 1EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

146 1EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

147 1EQ 200MG BASE/VIAL

148 1EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)

149 2EQ 20MG BASE/VIAL

150 1EQ 250MG BASE/25ML (EQ 10MG BASE/ML)

151 1EQ 250MG BASE/VIAL

152 1EQ 250MG/50ML (EQ 5MG/ML)

153 1EQ 25MG BASE/5ML (EQ 5MG BASE/ML)

154 4EQ 2MG BASE/ML

155 1EQ 300MG BASE/ML

156 1EQ 30MG BASE/10ML (EQ 3MG BASE/ML)

157 1EQ 350MG BASE/VIAL

158 1EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

159 1EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)

160 2EQ 40MG BASE/ML

161 2EQ 40MG BASE/VIAL

162 3EQ 4MG BASE/100ML

163 1EQ 4MG BASE/5ML

164 1EQ 4MG PHOSPHATE/ML

165 1EQ 500,000 UNITS BASE/VIAL

166 7EQ 500MG BASE/VIAL

167 1EQ 500MG/100ML (EQ 5MG/ML)

168 1EQ 500MG/20ML (EQ 25MG/ML)

169 2EQ 50MG BASE/ML

170 1EQ 50MG BASE/VIAL

171 1EQ 50MG PHENYTOIN NA/ML

172 1EQ 5GM BASE/VIAL

173 2EQ 5MG BASE/100ML

174 3EQ 5MG BASE/ML

175 1EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)

176 1EQ 750MG BASE/VIAL

177 1EQ 750MG/150ML (EQ 5MG/ML)

178 1EQ 750MG/30ML (EQ 25MG/ML)

filter Regulatory Info Reset all filters

239 All

01 5DISCN

02 4OTC

03 217RX

04 13Blank

List of Suppliers

Supplier Virtual Booth

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01

Brand Name : ACETAMINOPHEN

ICMD China

Not Confirmed

Brand Name : ACETAMINOPHEN

ICMD China

Not Confirmed

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RLD : No

TE Code : AP

ACETAMINOPHEN

GLAND PHARMA LIMITED

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : ACETAMINOPHEN

Dosage Strength : 500MG/50ML (10MG/ML)

Approval Date : 2025-04-02

Application Number : 219215

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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02

Brand Name : ACETAMINOPHEN

ICMD China

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Brand Name : ACETAMINOPHEN

ICMD China

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RLD : No

TE Code : AP2

ACETAMINOPHEN

GLAND PHARMA LIMITED

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : ACETAMINOPHEN

Dosage Strength : 1GM/100ML (10MG/ML)

Approval Date : 2025-04-02

Application Number : 219215

RX/OTC/DISCN : RX

RLD : No

TE Code : AP2

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03

Brand Name : ACETAZOLAMIDE SODIUM

ICMD China

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Brand Name : ACETAZOLAMIDE SODIUM

ICMD China

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RLD : No

TE Code : AP

ACETAZOLAMIDE SODIUM

GLAND PHARMA LIMITED

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : ACETAZOLAMIDE SODIUM

Dosage Strength : EQ 500MG BASE/VIAL

Approval Date : 2025-06-17

Application Number : 219775

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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04

Brand Name : ADENOSINE

ICMD China

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Brand Name : ADENOSINE

ICMD China

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RLD : No

TE Code : AP

GLAND PHARMA LIMITED

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : ADENOSINE

Dosage Strength : 3MG/ML

Approval Date : 2007-06-14

Application Number : 77283

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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05

Brand Name : ADENOSINE

ICMD China

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Brand Name : ADENOSINE

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RLD : No

TE Code : AP

GLAND PHARMA LIMITED

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : ADENOSINE

Dosage Strength : 3MG/ML

Approval Date : 2018-02-16

Application Number : 206778

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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06

Brand Name : ALCAFTADINE

ICMD China

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Brand Name : ALCAFTADINE

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RLD : No

TE Code :

ALCAFTADINE

GLAND PHARMA LIMITED

Dosage Form : SOLUTION/DROPS; OPHTHALMIC

Proprietary Name : ALCAFTADINE

Dosage Strength : 0.25%

Approval Date : 2024-03-01

Application Number : 209706

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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Brand Name : ALLOPURINOL SODIUM

ICMD China

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Brand Name : ALLOPURINOL SODIUM

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RLD : No

TE Code : AP

ALLOPURINOL SODIUM

GLAND PHARMA LIMITED

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : ALLOPURINOL SODIUM

Dosage Strength : EQ 500MG BASE/VIAL

Approval Date : 2022-01-26

Application Number : 212363

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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Brand Name : AMIODARONE HYDROCHLO...

ICMD China

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Brand Name : AMIODARONE HYDROCHLO...

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RLD : No

TE Code : AP

AMIODARONE HYDROCHLORIDE

GLAND PHARMA LIMITED

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : AMIODARONE HYDROCHLORIDE

Dosage Strength : 50MG/ML

Approval Date : 2005-04-20

Application Number : 77161

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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09

Brand Name : ANGIOTENSIN ll ACETA...

ICMD China

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Brand Name : ANGIOTENSIN ll ACETA...

ICMD China

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RLD : No

TE Code : AP

ANGIOTENSIN II ACETATE

GLAND PHARMA LIMITED

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : ANGIOTENSIN ll ACETATE

Dosage Strength : EQ 2.5MG BASE/ML (EQ 2.5...

Approval Date : 2025-06-03

Application Number : 216966

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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Brand Name : ARGATROBAN

ICMD China

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Brand Name : ARGATROBAN

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RLD : No

TE Code : AP

GLAND PHARMA LIMITED

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : ARGATROBAN

Dosage Strength : 50MG/50ML (1MG/ML)

Approval Date : 2023-07-31

Application Number : 217848

RX/OTC/DISCN : RX

RLD : No

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Contact Gland Pharma Limited and get a quotation

Gland Pharma Limited is a supplier offers 68 products (APIs, Excipients or Intermediates).

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