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Analytical Method Development and Validation Before the analysis of leachables samples, a test method must be developed and validated to ensure that the analytes of interest are not obscured or affected by the formulation of the drug product. Appropriate analytes of interest for testing are to be dertermined. Drawing from resources available in literature, or performing extractables profiles in chemistry laboratory, specific analytes of interest for a drug product are determined. Methods are dev

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01 1Famar

02 1Aspen API

03 1Bachem AG

04 1Fermion Oy

05 1Seqens

06 1Cayman Pharma s.r.o

07 1Mission | CDMO

08 1PMC Isochem

09 1Sharp

10 1Skyepharma

11 1ZACH System SA

12 1M2i Group

13 1Mikart

14 1NanoAlvand

15 1Neuland Laboratories

16 1Quotient Sciences

17 1ACTA Laboratories Inc

18 1ARx

19 1Acceleration Laboratory Services

20 1Adare Pharma Solutions

21 1Admix Pharma Laboratories, LLC

22 1Adragos Pharma

23 1Aizant Drug Research Solutions Pvt. Ltd.

24 1AlbyPharma

25 1Almelo

26 2Anacipher

27 1Angelini Pharma

28 1Appcure Labs

29 2Aragen Life Sciences

30 1Arbro Pharmaceuticals Pvt. Ltd

31 1Arcinova

32 1Arevipharma

33 1Ascent Innovative Medicines

34 1Ash Stevens

35 2Avaca Pharma

36 1Avivia

37 1Basic Pharma

38 1Bellen Chemistry

39 1Bio-Technology General Israel Ltd.

40 1Biolink LifeSciences

41 1Bioplus Life Sciences

42 1BirgiMefar Group

43 1Bluepharma

44 1Boston Analytical

45 1Cambrex Corporation

46 1Catalent Pharma Solutions

47 1Cebiphar

48 1ChemCon GmbH

49 1Chromcore Lifesciences

50 1Clearsynth Labs Limited

51 1Crenza Pharma

52 1Curia

53 1Curida AS

54 1Curtis Health Caps

55 1Cyndea Pharma S.L

56 1DPT Laboratories, Ltd

57 1Dishman Carbogen Amcis

58 1Diverchim S.A.

59 1Doctor's Analytical Laboratories

60 1Era Pharma Solutions

61 1Etico Lifesciences

62 1Eurofins BioPharma Services

63 1Evotec

64 1Flagship Biotech International Pvt. Ltd

65 1Fresenius SE & Co. KGaA

66 1FumoPrep

67 1GALENIX INNOVATIONS

68 1GALIEN LPS

69 1GRAM Laboratory Inc

70 1Globela Pharma

71 1Healios Labs

72 1JGL d.d

73 1JSL Health Sciences

74 1KriSan Biotech

75 1Labiana Life Sciences S.A

76 1Legacy Pharmaceuticals Switzerland

77 1Lonza Capsugel

78 1Lubrizol Life Science Health

79 1M2M Pharmaceuticals Ltd

80 1Madras Pharmaceuticals

81 1Maithili Life Sciences

82 2Megsan Labs Private Limited

83 1Menadiona

84 1Merck Millipore

85 1Mithra CDMO

86 1Neopharm Labs Inc

87 1Novick Biosciences

88 1Nutrasource

89 1ORIT LABS LLC

90 1Olive Healthcare

91 1Oncomed Manufacturing A.S

92 1Onyx Scientific

93 1Ortiv-Q3 Research

94 1Osmopharm

95 1PSR Pharma Science and Research

96 1PYRAMID Laboratories, Inc

97 1Pace Analytical Services, LLC

98 1PharmaVize NV

99 1Prague Scientific

100 1Progenerics Pharma Pvt Ltd

101 1Provepharm Life Solutions

102 1Proveris Scientific

103 1QUINTA-ANALYTICA s.r.o

104 2Quantex Laboratories

105 1RD Laboratories

106 1Rafarm S.A

107 1Recipharm AB

108 1Ropack Inc

109 1SGS Life Sciences

110 1STABICON LIFE SCIENCE PVT LTD

111 1Sai Life Sciences Limited

112 1Saneca Pharmaceuticals

113 1Santa S.A

114 1ScinoPharm Taiwan Ltd

115 1SeQuent Scientific

116 1Servier

117 2Shijiazhuang Rainbowlabs Pharmaceutical Technology

118 1Siegfried AG

119 1Societal CDMO

120 1Softigel Procaps

121 1Solara Active Pharma Sciences

122 1Solvias

123 1Stason Pharmaceuticals, Inc.

124 1Stira Pharmaceuticals

125 1Sushen Medicamentos Pvt. Ltd

126 1Symbiosis Pharmaceutical Services

127 1Tapemark Company

128 1Tepnel Pharma Services

129 1UQUIFA

130 1Unither Pharmaceuticals

131 1Vitas Analytical Services

132 1Zelmic

133 1mKnal Global Solutions

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