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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 1Neuland Laboratories

15 1Quotient Sciences

16 1ACTA Laboratories Inc

17 1ARx

18 1Acceleration Laboratory Services

19 1Adare Pharma Solutions

20 1Admix Pharma Laboratories, LLC

21 1Aizant Drug Research Solutions Pvt. Ltd.

22 1AlbyPharma

23 1Almelo

24 2Anacipher

25 1Angelini Pharma

26 1Appcure Labs

27 2Aragen Life Sciences

28 1Arbro Pharmaceuticals Pvt. Ltd

29 1Arcinova

30 1Arevipharma

31 1Ascent Innovative Medicines

32 1Ash Stevens

33 2Avaca Pharma

34 1Avivia

35 1Basic Pharma

36 1Bellen Chemistry

37 1Bio-Technology General Israel Ltd.

38 1Biolink LifeSciences

39 1Bioplus Life Sciences

40 1BirgiMefar Group

41 1Bluepharma

42 1Boston Analytical

43 1Cambrex Corporation

44 1Catalent Pharma Solutions

45 1Cebiphar

46 1ChemCon GmbH

47 1Chromcore Lifesciences

48 1Clearsynth Labs Limited

49 1Crenza Pharma

50 1Curia

51 1Curida AS

52 1Curtis Health Caps

53 1Cyndea Pharma S.L

54 1DPT Laboratories, Ltd

55 1Dishman Carbogen Amcis

56 1Diverchim S.A.

57 1Doctor's Analytical Laboratories

58 1Era Pharma Solutions

59 1Etico Lifesciences

60 1Eurofins BioPharma Services

61 1Evotec

62 1Flagship Biotech International Pvt. Ltd

63 1Fresenius SE & Co. KGaA

64 1FumoPrep

65 1GALENIX INNOVATIONS

66 1GALIEN LPS

67 1GRAM Laboratory Inc

68 1Globela Pharma

69 1Healios Labs

70 1JGL d.d

71 1JSL Health Sciences

72 1KriSan Biotech

73 1Labiana Life Sciences S.A

74 1Lamda Laboratories

75 1Legacy Pharmaceuticals Switzerland

76 1Lonza Capsugel

77 1Lubrizol Life Science Health

78 1M2M Pharmaceuticals Ltd

79 1Madras Pharmaceuticals

80 1Maithili Life Sciences

81 2Megsan Labs Private Limited

82 1Menadiona

83 1Merck Millipore

84 1Mithra CDMO

85 1Neopharm Labs Inc

86 1Novick Biosciences

87 1Nutrasource

88 1ORIT LABS LLC

89 1Olive Healthcare

90 1Oncomed Manufacturing A.S

91 1Onyx Scientific

92 1Ortiv-Q3 Research

93 1Osmopharm

94 1PSR Pharma Science and Research

95 1PYRAMID Laboratories, Inc

96 1Pace Analytical Services, LLC

97 1PharmaVize NV

98 1Prague Scientific

99 1Progenerics Pharma Pvt Ltd

100 1Provepharm Life Solutions

101 1Proveris Scientific

102 1QUINTA-ANALYTICA s.r.o

103 2Quantex Laboratories

104 1RD Laboratories

105 1Rafarm S.A

106 1Recipharm AB

107 1Ropack Inc

108 1SEQUENT SCIENTIFIC LTD

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 1Servier

116 2Shijiazhuang Rainbowlabs Pharmaceutical Technology

117 1Siegfried AG

118 1Societal CDMO

119 1Softigel Procaps

120 1Solara Active Pharma Sciences

121 1Solvias

122 1Stason Pharmaceuticals, Inc.

123 1Stira Pharmaceuticals

124 1Sushen Medicamentos Pvt. Ltd

125 1Symbiosis Pharmaceutical Services

126 1Tapemark Company

127 1Tepnel Pharma Services

128 1UQUIFA

129 1Unither Pharmaceuticals

130 1Vitas Analytical Services

131 1Zelmic

132 1Zenvision Pharma

133 1mKnal Global Solutions

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