Research & Development

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Our key areas of research

Covered an area of 10,000 square meters, complete R&D facilities and advanced testing techniques such as HPLC, GC, NMR (Bruker400MHz), LC-MS, infrared spectrophotometer or UV spectrophotometer to ensure the delivery of top- quality chemicals and meet different needs of our customers.

The well-equipped laboratory and excellent research staff (more than 200 chemists and scientists with over 10 years’ experience in the chemical industry) ensure top-quality products, and we have successfully developed hundreds of new compounds, including API, heterocyclic and benzene derivatives which have been widely used in pharmaceutical, dye, pesticide and other industries.

The support and trust of you power us to constantly develop new compounds to meet the growing demands of the market.

Polysaccharides

Cross-linked Hyaluronic acid - Chemical link between two chains of linear Hyaluronic acid makes it more stable and resistant towards enzymatic degradation.

Peptides

Peptide is 'Mer' of 40 or less amino acids. In addition to boosting collagen production, wound healing and joint recovery, benefits of peptide therapy encourage healthy cell repair and production.

capabilities

Formulations

Oral dosage forms: SR, Gastric floating systems
Injectables: Long acting, depot injections, targeted drug delivery systems
Ophthalmic: Eye drops, implants
Topicals: Ointments, creams, gels
Nano/ Microparticulate systems: Liposomes, polymeric nanoparticles, NLCs, dendrimeric peptides, microsponges, nanosponges, SMEDDS, solid dispersion, in situ gels, MOFs, etc and use of these drug delivery systems in above listed routes of administration.

Recombinant/Biological products

•Recombinant Albumin
•Recombinant Enterokinase
•L Asparaginase
•PEG- Asparaginase
•Enoxaparin

API

Commercial List

No. Molecule Therapy Area Dosage Form USDMF e-DMF CEP BDMF KDMF JDMF
1 Cyproterone Acetate Antiandrogen Tablet ü
2 Levofloxacin Hemihydrate Antibacterial Injection; Tablet ü ü ü
3 Linagliptin Anti-Diabetes Tablet ü
4 Granisetron Hydrochloride Anti-emetic Tablet; Injectable, Transdermal Patch ü ü ü
5 Ondanseteron Hydrochloride Anti-emetic Injection, Tablet ü ü ü
6 Granisetron Base Anti-emetic (CINV*) Tablet, Transdermal Patch ü ü ü
7 Ondanseteron Base Anti-emetic (CINV*) Tablet ü
8 Fluconazole Antifungal Tablet,Injectable,Cream ü ü ü ü
9 Terbinafine Hydrochloride Antifungal Tablet, cream ü ü
10 Cetirizine Dihydrochloride Antihistamine Tablet, Syrup, capsules ü ü ü
11 Levocetirizine Dihydrochloride Antihistamine Tablet; Solution ü ü ü ü
12 Desloratidine Antihistamine Tablet ü
13 Praziquantel Anti-infective Tablet ü ü
14 Celecoxib Anti-inflammatory Capsule ü ü ü ü
15 Meloxicam Anti-inflammatory Tablet, Capsule, Injection ü ü ü
16 Solifenacin succinate Antimuscarinic Tablet ü ü ü
17 Irinotecan hydrochloride trihydrate Antineoplastics Injection ü ü ü
18 Abacavir Sulphate Antiretroviral Tablet, Oral solution ü ü
19 Atazanavir sulphate Antiretroviral Capsule, Tablet, Powder ü ü
20 Efavirenz Antiretroviral Tablet and Capsule ü ü ü
21 Lamivudine Antiretroviral Tablet ü ü ü
22 Leflunomide Antirheumatic Tablet ü ü ü
23 Entecavir Monohydrate Antiviral Tablet ü ü
24 Famciclovir Antiviral Tablet ü ü
25 Oseltamivir Phosphate Antiviral Capsule; Suspension ü ü
26 Valacyclovir Hydrochloride Dihydrate Antiviral Tablet ü
27 Valganciclovir Hydrochloride Antiviral Tablet, Solution ü ü
28 Carvedilol Beta-Blockers, Alpha Activity Tablet ü ü
29 Ambrisentan Cardiovascular Tablet ü ü
30 Amlodipine Besylate Cardiovascular Tablet ü ü ü ü ü
31 Amlodipine Mesylate Cardiovascular Tablet ü ü ü
32 Anagrelide Hydrochloride Cardiovascular Capsule ü ü ü
33 Bosentan Monohydrate Cardiovascular Tablet ü ü
34 Felodipine Cardiovascular Tablet ü ü ü
35 Ramipril Cardiovascular Tablet and Capsule ü ü ü
36 Trimetazidine Dihydrochloride Cardiovascular Tablet ü ü ü ü
37 Citalopram Hydrobromide Central Nervous System Tablet, Solution ü ü ü
38 Donepezil Hydrochloride Central Nervous System Tablet ü ü ü
39 Escitalopram Oxalate Central Nervous System Tablet ü ü ü
40 Lamotrigine Central Nervous System Tablet ü ü
41 Pramipexole Dihydrochloride Monohydrate Central Nervous System Tablet ü ü
42 Pregabalin Central Nervous System Capsule ü ü
43 Risperidone Central Nervous System Tablet/Oral Solution ü ü ü ü
44 Rivastigmine Hydrogen Tartrate Central Nervous System Capsule, Trasdermal ü ü
45 Rizatriptan Benzoate Central Nervous System Tablet ü ü
46 Topiramate Central Nervous System Capsule, Tablet ü ü ü ü
47 Venlafaxine Hydrochloride Central Nervous System Capsule, Tablet ü ü
48 Alosetron Hydrochloride Gastrointestinal Tablet ü
49 Esomeprazole Magnesium Dihydrate Gastrointestinal Capsule, Tablet, Injection ü ü ü
50 Esomeprazole Magnesium Trihydrate Gastrointestinal Capsule ü ü
51 Lansoprazole Gastrointestinal Capsule ü
52 Omeprazole Gastrointestinal Tablet ü ü
53 Omeprazole Magnesium Gastrointestinal Tablet ü
54 Omeprazole Sodium Gastrointestinal Tablet,Injection ü ü
55 Palonosetron Hydrochloride Gastrointestinal Injection, Capsule ü ü ü
56 Pantoprazole Sodium Sesquihydrate Gastrointestinal Tablet, Injection ü ü ü
57 Cinacalcet Hydrochloride Hyperparathyroidism Tablet ü
58 Pirfenidone IPF (Idiopathic Pulmonary Fibrosis) Tablet, Capsule ü ü ü
59 Deferasirox Iron chelator Tablet, Granule ü ü ü
60 Bicalutamide Nonsteroidal Antiandrogens Tablet ü ü
61 Abiraterone Acetate Oncology Tablet ü ü ü
62 Erlotinib Hydrochloride Oncology Tablet ü ü ü ü
63 Etoposide Oncology Capsule;Injection ü ü ü
64 Exemestane Oncology Tablet ü ü ü
65 Gefitinib Oncology Tablet ü ü ü
66 Imatinib Mesylate Oncology Tablet ü ü ü ü
67 Lenalidomide Oncology Capsule ü ü ü
68 Letrozole Oncology Tablet ü ü
69 Pazopanib Hydrochloride Oncology Tablet ü ü ü
70 Sorafenib Tosylate Oncology Tablet ü ü
71 Alendronate Sodium Osteoporosis Tablet, Oral solution ü ü
72 Risedronate Sodium Osteoporosis Tablet ü ü ü
73 Albuterol/Salbutamol Sulphate Respiratory Aerosol Spray, Oral syrup, Tablet ü ü
74 Arformoterol Tartrate Respiratory Inhalation ü
75 Beclomethasone Dipropionate Respiratory Aerosal spray ü ü
76 Budesonide Respiratory Capsules, Inhalation Powder, Suspension ü ü
77 Ciclesonide Respiratory Capsule, Inhalation Aerosol ü ü ü
78 Formoterol Fumarate Dihydrate Respiratory Inhalation,Aerosol, solution ü ü ü
79 Levalbuterol Hydrochloride Respiratory Solution ü
80 Mometasone Furoate Respiratory Topical,Inhalation Aerosol ü ü ü
81 Mometasone Furoate Monohydrate Respiratory Topical,Inhalation Aerosol ü ü ü
82 Salmeterol Xinafoate Respiratory Inhalation Aerosol ü ü ü
83 Tiotropium Bromide Monohydrate Respiratory Inhalation Aerosol ü ü
84 Fluticasone Propionate Respiratory, Dermatology Inhalation Aerosol, Lotion, cream, ointment ü ü ü
85 Danazol Urology Capsule ü ü
86 Tamsulosin Hydrochloride Urology Capsule ü
87 Finasteride Urology,Dermatology Tablet ü ü ü

Pellets

No Molecule Therapy Area
1 Venlafaxine Pellets 32.60% Central Nervous System
2 Lansoprazole Pellets 8.33% Gastrointestinal
3 Omeprazole Pellets 8.33% Gastrointestinal
4 Omeprazole Pellets 8.5% Gastrointestinal
5 Tamsulosin Pellets 0.4mg Urology

New DMFs Filed

No Molecule Therapy Area
1 Edaravone Amyotrophic Lateral Sclerosis
2 Empagliflozin Anti-Diabetic
3 Linagliptin Anti-Diabetic
4 Efinaconazole Anti-Fungal
5 Bictegravir Sodium Anti-HIV
6 Cabotegravir Anti-HIV
7 Darunavir Antiretroviral
8 Dolutegravir Antiretroviral
9 Rilpivirine Antiretroviral
10 Tenofovir Alafenamide Fumarate Antiretroviral
11 Rivaroxaban Anti-Thrombotic
12 Nirmaltrelvir Antiviral (Covid)
13 Tafamidis Cardiovascular
14 Vortioxetine Central Nervous System
15 Difelikefalin Chronic Kidney disease
16 Sodium Thiosulphate Cisplatin induced Ototoxicity
17 Nintedanib Idiopathic Pulmonary Fibrosis
18 Eliglustat Metabolic Disorder
19 Siponimod Fumarate Multiple Sclerosis
20 Acalabrutinib Oncology
21 Dasatinib Oncology
22 Enzalutamide Oncology
23 Nilotinib Oncology
24 Olaparib Oncology
25 Pomalidomide Oncology
26 Ticagrelor Platelet Aggregation Inhibitor
27 Apremilast Psoriatic Arthritis
28 Fluticasone Furoate Respiratory
29 Indacaterol Respiratory
30 Revefenacin Respiratory
31 Mirabegron Urological

Under development APIs

No Molecule Therapy Area Stage
1 Edoxaban Anti-coagulant Lab Development
2 Tirzepatide Anti-Diabetes Lab Development
3 Isavuconazonium Anti-Fungal Pre-Validation
4 Rifapentine Anti-Infectives Plant validation
5 Ensifentrine Anti-inflammatory Lab Development
6 Apixaban Anti-Thrombotic Pre-Validation
7 Levoglutamide Anti-ulcerative Lab Development
8 Brexpiprazole CNS Validation
9 Deucravacitinib Immunosuppressant Lab Development
10 Niraparib Oncology Lab Development
11 Relugolix Oncology Pre-Validation
12 Ruxolitinib Oncology Plant Validation
13 Glycopyrronium Respiratory Commercial
14 Vilanterol Trifenatate Respiratory Plant Validation
15 Abemaciclib Oncology Lab development
16 Alectinib Oncology Lab development
17 Venetoclax Oncology Lab development
18 Lenacapavir Anti retroviral Lab development
19 Ivacaftor Cystic Fibrosis Lab development
20 Deutavacaftor Cystic Fibrosis Lab development
21 Zavagepant CNS Lab development
22 Resmetirom NASH Lab development
23 Patiromer Hyperkalemia Lab development
24 Ixazomib Oncology Lab development
25 Etripamil Cardiovascular Lab development
26 Terlipressin Chronic kidney disorders Lab development
27 Daprodustat Anemia Lab development

Crosslinked HA Ophthalmic

Crosslinked Hyaluronic acid

  • Cross-linking is a chemical strategy that links HA (Hyaluronic acid) molecules to one another,
    creating a polymer network.
  • This process extends the retention properties of HA and decreases its susceptibility to enzymatic
    degradation, which ultimately reduces the number of times it needs to be re-applied.

Technology

  • The cross-link is a process that allows linear hyaluronic acid molecules to be linked together, to obtain new
    structures consisting of several hyaluronic acid filaments with a higher molecular weight.
  • In the cross-linking reaction, two of hyaluronic acid, hyaluronate, derivatives thereof or a mixture thereof form
    chemical bond such as ether bond in the present invention between two straight chains without producing by
    product, so a cross-linking reaction is theoretically proceeded completely

Applications – Dry Eye Syndrome

Artificial tears – dry eye syndrome

  • The main limitation of non-cross-linked HA containing tear replacement therapies is the
    frequency at which patient need to apply the medication (4 to 6 times daily) in order to
    achieve an appropriate response to treatment. Crosslinked HA has more viscoelastic
    properties, allowing patients to use only once or twice daily.
  • In dry eye disease, crosslinked HA as tear supplement seems to provide better ocular
    comfort than linear HA.
  • Crosslinked HA is resistant to degradation
  • Crosslinked HA has a better bioavailability

Sol-Gel eye drops containing Crosslinked HA

  • Crosslinked HA showed clarity in simulated tear fluid– mandatory property of an
    eye drops
    Which is in line with commercially available non-crosslinked HA eye drops
  • Crosslinked HA is forming a gel/translucent mass at the bottom which is
    indicating towards formation of a depot.
  • Depot formation – reduce frequency of administration

Crosslinked HA API (Ophthalmic)– data sheet

Name of the Test
Specification Criteria
Ophthalmic grade
Description
White or almost white, very hygroscopic powder or fibrous aggregate.
White, fibrous aggregate
Solubility
Sparingly soluble or soluble in water, practically insoluble in acetone and in anhydrous ethanol.
Sparingly soluble in water, practically insoluble in acetone and in anhydrous ethanol
PH
5.0 to 8.5
Appearance of Solution
Solution S shall be clear and its absorbance at 600 nm is not greater than 0.01.
Solution S is clear and its absorbance at 600 nm is 0.004
Nucleic acids
The absorbance of solution at 260 nm shall be maximum 0.5.
0.2
Chlorides
Maximum 0.5 %
Less than 0.5 %
Loss on drying
Maximum 20.0% w/w
11.0 % w/W
Assay (determine the glucuronic acid content by reaction with carbazole)
95.0 % to 105% (Dried substance)
101.1% on dried substance
BDDE content
Less than 2ppm
Not detected

CAPABILITIES AND INFRASTRUCTURE