TICOCIN Injection (Teicoplanin)

Table of Content

For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only

Qualitative and Quantitative Composition

TICOCIN-200

Each vial contains:
Teicoplanin, IP..................................... 200 mg

Excipients……………………………….q.s.

TICOCIN-400

Each vial contains:
Teicoplanin, IP..................................... 400 mg

Excipients……………………………….q.s.

Dosage Form(s) and Strength(s)

Sterile lyophilised powder filled in a vial (200 mg and 400 mg) for reconstitution for intravenous (IV)/intramuscular (IM) use only.

Clinical Particulars

Therapeutic Indications

TICOCIN injection is indicated for use in serious gram-positive infections, staphylococcal infections in patients sensitive or unresponsive to penicillin and cephalosporins, continuous ambulatory peritoneal dialysis (CAPD)-related peritonitis, and as prophylaxis in orthopaedic surgery cases at risk for gram-positive infections.

Posology and Method of Administration

Dosage

The dose and duration of treatment should be adjusted according to the underlying type and severity of infection and clinical response of the patient, and patient factors such as age and renal function.

Measurement of Serum Concentrations

Teicoplanin trough serum concentrations should be monitored at steady state after completion of the loading dose regimen in order to ensure that a minimum trough serum concentration has been reached:

  • FOR MOST GRAM-POSITIVE INFECTIONS: Teicoplanin trough levels of at least 10 mg/L when measured by high-performance liquid chromatography (HPLC), or at least 15 mg/L when measured by fluorescence polarisation immunoassay (FPIA) method.
  • FOR ENDOCARDITIS AND OTHER SEVERE INFECTIONS: Teicoplanin trough levels of 15–30 mg/L when measured by HPLC, or 30–40 mg/L when measured by the FPIA method.

During maintenance treatment, teicoplanin trough serum concentrations monitoring may be performed at least once a week to ensure that these concentrations are stable.

Adults and Elderly Patients with Normal Renal Function

Indications

Loading dose

regimen

Targeted trough

concentrations at days 3 to 5

Maintenance dose

Targeted trough

concentrations during

maintenance

 

Complicated

skin and soft tissue infections

 

Pneumonia

 

Complicated

urinary tract infections

400 mg

IV or

IM

(this equates to

approximately 6

mg/kg body

weight) every 12

hours, for three

administrations

>15 mg/L1

6 mg/kg body weight

IV or

IM once a

day

>15 mg/L1

once a week

Bone

and joint

infections

800 mg

IV (this

equates to

approximately 12

mg/kg body

weight) every 12

hours for three to five

administrations

>20 mg/L1

 

 

12 mg/kg body weight

IV or

IM once a

day

 

>20 mg/L1

Infective

endocarditis

800 mg IV (this

equates to

approximately       12 mg/kg body

weight) every             12 hours, for three to five administrations

30–40

mg/L1

12 mg/kg body weight

IV or IM once a day

>30 mg/L1

1 Measured by FPIA

The dose is to be adjusted for body weight (whatever is the weight of the patient).

Geriatric Patients

No dose adjustment is required unless there is renal impairment (see below).

Adults and Geriatric Patients with Impaired Renal Function

Dose adjustment is not required until the fourth day of treatment, at which time dosing should be adjusted to maintain a serum trough concentration of at least 10 mg/L when measured by HPLC, or at least 15 mg/L when measured by FPIA method.

After the fourth day of treatment:

IN MILD AND MODERATE RENAL INSUFFICIENCY (CREATININE CLEARANCE 30–80 mL/min): maintenance dose should be halved, either by administering the dose every two days or by administering half of this dose once a day.

IN SEVERE RENAL INSUFFICIENCY (CREATININE CLEARANCE <30 ML/MIN) AND IN HAEMODIALYSED PATIENTS: dose should be one-third the usual dose, either by administering the initial unit dose every third day or by administering one-third of this dose once a day.

Teicoplanin is not removed by haemodialysis.

Patients in CAPD

After a single IV loading dose of 6 mg/kg body weight, 20 mg/L is administered in the bag of the dialysis solution in the first week, 20 mg/L in different bags the second week, and then 20 mg/L in the overnight bag in the third week.

Paediatric Patients

The dose recommendations are the same in adults and children above 12 years of age.

NEONATES AND INFANTS (UP TO THE AGE OF 2 MONTHS)

LOADING DOSE: One single dose of 16 mg/kg body weight, administered by IV infusion on the first day.

MAINTENANCE DOSE: One single dose of 8 mg/kg body weight administered by IV infusion once a day.

CHILDREN (2 MONTHS TO 12 YEARS)

LOADING DOSE: One single IV dose of 10 mg/kg body weight administered every 12 hours, repeated three times.

MAINTENANCE DOSE: One single IV dose of 6–10 mg/kg body weight administered once a day.

Duration of Treatment

The duration of treatment should be decided based on the clinical response of the patient. For infective endocarditis, a minimum of 21 days is usually considered appropriate. Treatment should not exceed 4 months.

Combination Therapy

Teicoplanin has a limited spectrum of antibacterial activity (gram-positive). It is not suitable for use as a single agent for the treatment of some types of infections unless the pathogen is already documented and known to be susceptible or there is a high suspicion that the most likely pathogen(s) would be suitable for treatment with teicoplanin.

Method of Preparation

Add 3 mL of Sterile Water for Injections, IP, to reconstitute the vial of teicoplanin and roll the vial gently until the powder is completely dissolved, taking care to avoid formation of foam. If the solution does become foamy, then allow to stand for about 15 minutes for the foam to subside.

The reconstituted solution may be injected directly or, alternatively, diluted with any of the following:

0.9% Sodium Chloride Injection

5% Dextrose Injection  

Method of Administration

  • Teicoplanin should be administered by the IV or IM route.
  • The IV injection may be administered either as a bolus over 3–5 minutes or as a 30-minute infusion.
  • Only the infusion method should be used in neonates.

Contraindications

Hypersensitivity to teicoplanin or to any of the excipients.

Special Warnings and Precautions for Use

General

Hypersensitivity Reactions

Serious, life-threatening hypersensitivity reactions, sometimes fatal, have been reported with teicoplanin (e.g. anaphylactic shock). If an allergic reaction to teicoplanin occurs, treatment should be discontinued immediately, and appropriate emergency measures should be initiated.

Teicoplanin must be administered with caution in patients with known hypersensitivity to vancomycin, as crossed hypersensitivity reactions, including fatal anaphylactic shock, may occur.

However, a prior history of ‘red man syndrome’ with vancomycin is not a contraindication to the use of teicoplanin.

Infusion-related Reactions

In rare cases (even at the first dose), red man syndrome (a complex of symptoms, including pruritus, urticaria, erythema, angioneurotic oedema, tachycardia, hypotension and dyspnoea) has been observed.

Stopping or slowing the infusion may result in cessation of these reactions. Infusion-related reactions can be limited if the daily dose is not given via bolus injection but infused over a 30-minute period.

Severe Bullous Reactions

Life-threatening or even fatal cutaneous reactions, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of teicoplanin. If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, teicoplanin treatment should be discontinued immediately.

Spectrum of Antibacterial Activity

Teicoplanin has a limited spectrum of antibacterial activity (gram-positive). It is not suitable for use as a single agent for the treatment of some types of infections unless the pathogen is already documented and known to be susceptible or there is a high suspicion that the most likely pathogen(s) would be suitable for treatment with teicoplanin.

The rational use of teicoplanin should take into account the bacterial spectrum of activity, the safety profile and the suitability of standard antibacterial therapy to treat the individual patient. On this basis, it is expected that in most instances teicoplanin will be used to treat severe infections in patients for whom standard antibacterial activity is considered to be unsuitable.

Loading Dose Regimen

Since data on safety are limited, patients should be carefully monitored for adverse reactions when teicoplanin doses of 12 mg/kg body weight twice a day are administered. Under this regimen blood creatinine values should be monitored in addition to the recommended periodic haematological examination. Teicoplanin should not be administered by intraventricular use.

Thrombocytopaenia

Thrombocytopaenia has been reported with teicoplanin. Periodic haematological examinations are recommended during treatment, including complete cell blood count.

Nephrotoxicity

Renal failure has been reported in patients treated with teicoplanin. Patients with renal insufficiency, and/or in those receiving teicoplanin in conjunction with or sequentially with other medicinal products with known nephrotoxic potential (aminoglycosides, colistin, amphotericin B, ciclosporin, and cisplatin) should be carefully monitored, and should include auditory tests.

Since teicoplanin is mainly excreted by the kidneys, the dose of teicoplanin must be adapted in patients with renal impairment.

Ototoxicity

As with other glycopeptides, ototoxicity (deafness and tinnitus) has been reported in patients who develop signs and symptoms of impaired hearing or disorders of the inner ear during treatment with teicoplanin should be carefully evaluated and monitored, especially in case of prolonged treatment and in patients with renal insufficiency. Patients receiving teicoplanin in conjunction with or sequentially with other medicinal products with known neurotoxic/ototoxic potential (aminoglycosides, ciclosporin, cisplatin, furosemide and ethacrynic acid) should be carefully monitored and the benefit of teicoplanin evaluated if hearing deteriorates.

Special precautions must be taken when administering teicoplanin in patients who require concomitant treatment with ototoxic and/or nephrotoxic medicinal products for which it is recommended that regular haematology, liver and kidney function tests are carried out.

Superinfection

As with other antibiotics, the use of teicoplanin, especially if prolonged, may result in overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.

Drug Interactions

No specific interaction studies have been performed.

Teicoplanin and aminoglycoside solutions are incompatible and must not be mixed for injection; however, they are compatible in dialysis fluid and may be freely used in the treatment of CAPD-related peritonitis. Teicoplanin should be used with care in conjunction with or sequentially with other medicinal products with known nephrotoxic or ototoxic potential. These include aminoglycosides, colistin, amphotericin B, ciclosporin, cisplatin, furosemide, and ethacrynic acid. However, there is no evidence of synergistic toxicity in combinations with teicoplanin.

In clinical studies, teicoplanin has been administered to many patients already receiving various medications, including other antibiotics, antihypertensives, anaesthetic agents, cardiac medicinal products and antidiabetic agents, without evidence of adverse interaction.

Use in Special Populations

Patients with Renal Impairment

Please refer to Posology and Method of Administration.

Pregnant Women

There are limited amount of data from the use of teicoplanin in pregnant women. Studies in animals have shown reproductive toxicity at high doses in rats there was an increased incidence of stillbirths and neonatal mortality. The potential risk for humans is unknown. Therefore, teicoplanin should not be used during pregnancy unless clearly necessary. A potential risk of inner ear and renal damage to the foetus cannot be excluded.

Lactating Women 

It is unknown whether teicoplanin is excreted in human milk. There is no information on the excretion of teicoplanin in animal milk. A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with teicoplanin should be made taking into account the benefit of breastfeeding to the child and the benefit of teicoplanin therapy to the mother.

Fertility

Animal reproduction studies have not shown evidence of impairment of fertility.

Paediatric Use

Please refer to Posology and Method of Administration.

Effects on Ability to Drive and Use Machines

Teicoplanin can cause dizziness and headache. The ability to drive or use machines may be affected. Patients experiencing these undesirable effects should not drive or use machines.

Undesirable Effects 

Tabulated List of Adverse Reactions

In the table below, all the adverse reactions, which occurred at an incidence greater than placebo and more than one patient are listed using the following convention:

very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Adverse reactions should be monitored when teicoplanin doses of 12 mg/kg body weight twice a day are administered.

System organ class

Common

( 1/100 to <1/10)

Uncommon

( 1/1,000 to <1/100)

Rare

( 1/10,000 to <1/1,000)

Very rare

(<1/10,000)

Not known (cannot be estimated from available data)

Infections and infestations

 

 

Abscess

 

Superinfection (overgrowth of non-susceptible organisms)

Blood and lymphatic system disorders

 

Leucopaenia, thrombocyto-paenia, eosinophilia

 

 

Agranulocytosis, neutropaenia

Immune system disorders

 

 

 

Anaphylactic reaction (anaphylaxis)

 

 

Drug reaction with eosinophilia and systemic symptoms (DRESS), anaphylactic shock

Nervous system disorders

 

Dizziness, headache

 

 

Seizures 

Ear and labyrinth disorders

 

Deafness, hearing loss, tinnitus, vestibular disorder

 

 

 

Vascular disorders

 

Phlebitis

 

 

Thrombophlebitis

Respiratory, thoracic and mediastinal disorders

 

Bronchospasm

 

 

 

Gastrointestinal disorders

 

Diarrhoea, vomiting, nausea

 

 

 

Skin and sub-cutaneous tissue disorders

Rash, erythema,  pruritus

 

Red man syndrome (e.g. flushing of the upper part of the body)

 

Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, angio-oedema, dermatitis exfoliative, urticaria

Renal and urinary disorders

 

Blood creatinine increased

 

 

Renal failure (including renal failure acute)

General disorders and administration site conditions

Pain, pyrexia 

 

 

 

Injection-site abscess, chills (rigors)

Investigations

 

Transaminases increased (transient abnormality of transaminases), blood alkaline phosphatase increased (transient abnormality of alkaline phosphatase), blood creatinine increased (transient rise in serum creatinine)

     

Overdose 

Symptoms

Cases of accidental administration of excessive doses to paediatric patients have been reported. In one case, agitation occurred in a 29-day old newborn who had been administered 400 mg intravenously (95 mg/kg).

Management

Treatment of teicoplanin overdose should be symptomatic. Teicoplanin is not removed by haemodialysis and removed only slowly by peritoneal dialysis.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side effects directly via the national Pharmacovigilance Programme of India by calling on 1800 180 3024 or you can report to Cipla Ltd. on 1800 267 7779. By reporting side effects, you can help provide more information on the safety of this product.

Pharmacological Properties

Pharmacodynamic Properties 

Teicoplanin is a bactericidal, glycopeptide antibiotic.

Mechanism of Action

Teicoplanin inhibits the growth of susceptible organisms by interfering with cell wall biosynthesis at a site different from that affected by beta-lactams. Peptidoglycan synthesis is blocked by specific binding to D-alanyl-D-alanine residues.

Mechanism of Resistance

Resistance to teicoplanin can be based on the following mechanisms:

  • The modified target structure form of resistance has occurred, particularly in Enterococcus faecium. The modification is based on exchange of the terminal D-alanine-D-alanine function of the amino acid chain in a murein precursor with D-ala-D-lactate, thus reducing the affinity to vancomycin. The responsible enzymes are a newly synthesised D-lactate dehydrogenase or ligase.
  • The reduced sensitivity or resistance of staphylococci to teicoplanin is based on the overproduction of murein precursors to which teicoplanin is bound.
  • Cross-resistance between teicoplanin and the glycoprotein vancomycin may occur. A number of vancomycin-resistant enterococci are sensitive to teicoplanin (Van-B phenotype).

Susceptibility

The prevalence of resistance may vary geographically and over time for selected species and local information on resistance is desirable, particularly when treating severe infections. Where necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.

Commonly Susceptible Species

AEROBIC GRAM-POSITIVE BACTERIA

Corynebacterium jeikeiuma

Enterococcus faecalis

Staphylococcus aureus (including methicillin-resistant strains)

Streptococcus agalactiae

Streptococcus dysgalactiae subsp. equisimilisa

(Group C and G streptococci)

Streptococcus pneumoniae

Streptococcus pyogenes

Streptococci in the viridans groupa,b

ANAEROBIC GRAM-POSITIVE BACTERIA

Clostridium difficilea

Peptostreptococcus spp.a

Species for Which Acquired Resistance May Be a Problem

AEROBIC GRAM-POSITIVE BACTERIA

Enterococcus faecium

Staphylococcus epidermidis

Staphylococcus haemolyticus

Staphylococcus hominis

Inherently Resistant Bacteria

All gram-negative bacteria

Other Bacteria

Chlamydia spp.

Chlamydophila spp.

Legionella pneumophila

Mycoplasma spp.

a No current data were available when the tables were published. The primary literature, standard volumes and treatment recommendations assume sensitivity.

b Collective term for a heterogeneous group of Streptococcus species. Resistance rate can vary depending on the actual Streptococcus species.

Pharmacokinetic Properties

Teicoplanin exhibited linear pharmacokinetics at a dose range of 2–25 mg/kg.

Absorption

Teicoplanin is administered by the parenteral route (IV or IM). After IM administration, the bioavailability of teicoplanin (as compared with IV administration) is almost complete (90%). After six daily IM administrations of 200 mg, the mean (SD) maximum teicoplanin concentration (Cmax) amounted to 12.1 (0.9) mg/L and occurred at 2 hours after administration.

After a loading dose of 6 mg/kg administered via the IV route every 12 hours for three to five administrations, Cmax values range from 60 to 70 mg/L and Ctrough are usually above 10 mg/L. After an IV loading dose of 12 mg/kg administered every 12 hours for three administrations, mean values of Cmax and Ctrough are estimated to be around 100 mg/L and 20 mg/L, respectively.

After a maintenance dose of 6 mg/kg administered once daily, Cmax and Ctrough values are approximately 70 mg/L and 15 mg/L, respectively. After a maintenance dose of 12 mg/kg once daily, Ctrough values range from 18 to 30 mg/L.

Distribution

The binding to human serum proteins ranges from 87.6 to 90.8%, without any variation in function of the teicoplanin concentrations. Teicoplanin is mainly bound to human serum albumin. Teicoplanin is not distributed into red cells.

The volume of distribution at steady state (Vss) varies from 0.7 to 1.4 mL/kg. The highest values of Vss were observed in the recent studies where the sampling period was more than 8 days.

Teicoplanin is distributed mainly in the lungs, myocardium and bone tissues with tissue/serum ratios superior to 1. In blister fluids, synovial fluid and peritoneal fluid, the tissue/serum ratios ranged from 0.5 to 1. Elimination of teicoplanin from peritoneal fluid occurs at the same rate as from serum. In pleural fluid and subcutaneous fat tissue, the tissue/serum ratios are between 0.2 and 0.5. Teicoplanin does not readily penetrate into the cerebrospinal fluid (CSF).

Metabolism

The unchanged form of teicoplanin is the main compound identified in plasma and urine, indicating minimal metabolism. Two metabolites are formed, probably by hydroxylation, and represent 2–3% of the administered dose.

Elimination

Unchanged teicoplanin is mainly excreted by the urinary route (80% within 16 days) while 2.7% of the administered dose is recovered in the faeces (via bile excretion) within 8 days following administration.

Elimination half-life of teicoplanin varied from 100 to 170 hours in the most recent studies where blood sampling duration was about 8–35 days.

Teicoplanin has a low total clearance in the range of 10–14 mL/h/kg and a renal clearance in the range of 8–12 mL/h/kg, indicating that teicoplanin is mainly excreted by renal mechanisms.

Special Populations

Patients with Renal Impairment

As teicoplanin is eliminated by the renal route, teicoplanin elimination decreases according to the degree of renal impairment. The total and renal clearances of teicoplanin depends on the creatinine clearance.

Geriatric Patients

In the elderly population, the teicoplanin pharmacokinetics is not modified unless in case of renal impairment.

Paediatric Patients

A higher total clearance (15.8 mL/h/kg for neonates, 14.8 mL/h/kg for a mean age of 8 years) and a shorter elimination half-life (40 hours for neonates; 58 hours for 8 years of age) are observed compared with adult patients.

Pharmacokinetic/Pharmacodynamic Relationship

Teicoplanin antimicrobial activity depends essentially on the duration of time during which the substance level is higher than the minimum inhibitory concentration (MIC) of the pathogen.

Non-Clinical Properties

Animal Toxicology or Pharmacology

Preclinical Safety Data

Following repeated parenteral administration to the rat and dog, effects on the kidneys were observed and were shown to be dose-dependent and reversible. Studies to investigate the potential to cause ototoxicity in the guinea pig indicate that a mild impairment of cochlear and vestibular function is possible in the absence of morphological damage.

Subcutaneous administration of teicoplanin at up to 40 mg/kg/day did not affect male and female fertility in the rat. In embryo-foetal development studies, no malformations were observed following subcutaneous administration of up to 200 mg/kg/day in the rat and IM administration up to 15 mg/kg/day in the rabbit. However, in the rat, there was an increased incidence of stillbirths at doses of 100 mg/kg/day and above and neonatal mortality at 200 mg/kg/day. This effect was not reported at 50 mg/kg/day. A peri- and postnatal study in rats showed no effects on the fertility of the F1 generation or on the survival and development of the F2 generation following subcutaneous administration of up to 40 mg/kg/day.

Teicoplanin did not show any potential to cause antigenicity (in mice, guinea pigs or rabbits), genotoxicity or local irritancy.

Pharmaceutical Particulars

Incompatibilities

Teicoplanin and aminoglycoside are incompatible when mixed directly and must not be mixed before injection.

If teicoplanin is administered in combination therapy with other antibiotics, the preparation must be administered separately.

This medicinal product must not be mixed with other medicinal products except those mentioned under Posology and Method of Administration.

Shelf-Life

Please see manufacturing date and expiry date printed on pack. Do not use the product after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. 

Packaging Information

TICOCIN-200 injection and TICOCIN-400 injection: Available in vials of 10 mL.

Storage and Handling Instructions

Before Opening

Do not store above 30°C. Keep out of the reach and sight of children.

For Reconstitution

Before use, reconstitute TICOCIN injection with 3 mL of Sterile Water for Injections, IP. Do not use if the solution contains particles or if the solution is not clear.

After Reconstitution

Reconstituted solution should be stored at 2°–8°C for up to 24 hours.

Patient Counselling Information

  1. What TICOCIN injection is and what it is used for

TICOCIN injection is an antibiotic. It contains a medicine called teicoplanin. It works by killing the bacteria that cause infections in your body.

TICOCIN injection is used in adults and children (including newborn babies) to treat bacterial infections of

  • the skin and tissues underneath the skin (sometimes called soft tissue)
  • the bones and joints
  • the lungs
  • the urinary tract
  • the heart – e.g. endocarditis (inflammation of the endocardium and heart valves)
  • the abdominal wall – e.g. peritonitis (inflammation of the peritoneum)
  • the blood, when caused by any of the conditions listed above
  1. What you need to know before you use TICOCIN injection

Do not use TICOCIN injection if

  • you are allergic to teicoplanin or any excipient of this medicine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given TICOCIN injection if

  • you are allergic to an antibiotic called vancomycin
  • you have a red rash that develops on the face, neck or upper part of your body (red man syndrome)
  • you have a decrease in platelet count (thrombocytopaenia)
  • you have kidney problems
  • you are taking other medicines that may cause hearing problems and/or kidney problems. You may have regular tests to check if your kidneys and/or liver are working properly.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given TICOCIN injection.

  1. How TICOCIN injection is given

The medicine will normally be given to you by a doctor or nurse.

  • It will be given by injection into a vein (intravenous use) or muscle (intramuscular use).
  • It can also be given as an infusion through a drip into a vein.

Only infusion should be given in babies from birth to the age of 2 months.

  1. How to store TICOCIN injection

Store below 30°C and keep this medicine out of reach and sight of children. Do not use this medicine after the expiry date that is stated on the carton and label of the vial after expiry date. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions.

  1. Contents of the pack and other information.

The active substance in the TICOCIN injection is teicoplanin. Each vial contains either 200 mg or 400 mg of teicoplanin in vials of 10 mL.

Details of The Manufacturer/Marketer

Mfd. by: BDR PHARMACEUTICALS INT’L PVT. LTD.

At: Plot No. G-84/1, Tarapur M.I.D.C, Boisar,

Palghar, Boisar - 401506.

Marketed by: Cipla Ltd

Regd. Office: Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai – 400 013, India

Details of Permission or Licence Number with Date

MH/103525A dated 19/01/2021

Date of Revision

19/01/2021